Técnica de Medición

Transcription

Técnica de Medición

2012
ESTUDIO NACIONAL DE SALUD Y ENVEJECIMIENTO EN MÉXICO
(ENASEM-II)
Manual de Procedimientos
Antropométricos y Muestra Biológica
Septiembre del 2012
Manual de Procedimientos Antropométricos y Muestra Biológica
Estudio Nacional de Salud y Envejecimiento en México (ENASEM-II)
Responsable: Juan Pablo Gutiérrez (jpgutier@correo.insp.mx)
Elaboración
Responsable: Aurora Franco Núñez (afranco@correo.insp.mx)
1
INDICE
Introducción ...................................................................................................................... 3
Aspectos Generales ........................................................................................................ 5
Funciones Y Responsabilidades del Antropometrista ..................................................... 5
Lineamientos Generales para el Levantamiento ............................................................. 8
Procedimientos para un Levantamiento de Calidad ........................................................ 8
Presión Arterial .............................................................................................................. 10
Puntos Antropométricos ................................................................................................ 12
La Antropometría ........................................................................................................... 12
Peso .............................................................................................................................. 13
Talla ............................................................................................................................... 16
Circunferencia de Cintura .............................................................................................. 19
Circunferencia de Cadera .............................................................................................. 21
Medición de la Altura de la Rodilla ................................................................................ 22
Medición de Altura Sentado......................................................................................... 24
Medidas de Desempeño ................................................................................................ 25
Velocidad de la Marcha ................................................................................................. 27
Prueba de la Fuerza de Presión. ................................................................................... 30
Obtención de Muestras de Sangre Capilar .................................................................... 33
Determinación de Hemoglobina Glucosilada ................................................................. 34
Determinación de Hemoglobina .................................................................................... 38
Toma de Muestra Sanguínea ........................................................................................ 43
Técnica para Extracción Venosa ................................................................................... 45
Procedimiento Después de la Toma de Muestra Sanguínea ........................................ 48
Diagrama de Flujo de la Antropometría ......................................................................... 49
Bibliografía..................................................................................................................... 50
Apéndice I. Biomarcadores ............................................................................................ 51
Apéndice II. Nota Técnica sobre el Método de Análisis de Laboratorio para la
Determinación de Colesterol .......................................................................................... 67
2
INTRODUCCION
El Estudio Nacional de Salud y Envejecimiento en México (ENASEM, II) es un estudio
prospectivo poblacional acerca de la dinámica de la salud y el envejecimiento en
México. El objetivo general del estudio es contribuir en la generación de nuevo
conocimiento sobre envejecimiento y salud de los adultos mayores en México.
El estudio incluye una encuesta longitudinal1 en hogares usando una muestra
representativa nacional de personas de 50 años o más, la cual se levantó en 2001 con
seguimiento a los mismos sujetos en 2003. El levantamiento actual de la ENASEM
representa la tercera medición del estudio.
Participan en el estudio hombres y mujeres de 50 años y más seleccionados en el
estudio desde el 2001, así como sus respectivos cónyuges. Para el 2012 se contará
con una muestra adicional de nuevos participantes. En el levantamiento de la
información participa el Instituto Nacional de Estadística Geografía e Informática
(INEGI) en la aplicación de los cuestionarios y el Instituto Nacional de Salud Pública
(INSP) en la realización de mediciones antropométricas, medidas de desempeño
funcional y en la toma de la tensión arterial. Así mismo, el INSP se encargara de la
aplicación de pruebas in sitúo para la determinación de hemoglobina y hemoglobina
glucosilada y de la obtención de una muestra de sangre para la determinación en
laboratorio de biomarcadores biológicos y otra muestra será almacenada para realizar
en un futuro estudios genéticos (Los factores genéticos se asocian con enfermedades
comunes como la diabetes y las enfermedades cardiovasculares, y se relacionan con
aspectos biológicos del proceso de envejecimiento).
Cabe mencionar que mientras el INEGI aplicará los cuestionarios al total de
participantes en el estudio, el INSP se enfocará en una submuestra de los mismos. La
sub-muestra estará comprendida por la muestra total de cuatro estados.
1
Un estudio de seguimiento es aquel en el que un grupo de sujetos usualmente seleccionados al azar
es medido en varias ocasiones el tiempo, es decir, se repite el estudio en varios momentos en el
tiempo.
3
En estas áreas, el personal del INEGI llevará a cabo la entrevista en el hogar y
notificará a los encuestados que acepten participar en el estudio que en
aproximadamente dos semanas, el personal de salud del INSP acudirá al hogar a
solicitar su participación en una segunda fase del estudio.
El INEGI entregará periódicamente al INSP el listado de personas que aceptaron
responder los cuestionarios [participantes y cónyuges (si aplica)]. El personal del
INSP identificará a dichas personas y previo consentimiento informado se efectuarán
los siguientes procedimientos:
Mediciones antropométricas (talla, peso, circunferencia de cintura y cadera, talla
sentado y altura de la rodilla, tensión arterial)
Pruebas de desempeño [balance con el pie derecho e izquierdo, velocidad de la
marcha y fuerza de agarre].
Toma de muestras de sangre venosa
Toma de muestra de sangre capilar
En el presente manual se establecen los lineamientos para efectuar correctamente las
mediciones antropométricas, medidas de desempeño, toma de tensión arterial y toma
de muestras de sangre.
4
Aspectos generales
Un adecuado levantamiento de información se basa en el cumplimiento de las
funciones y responsabilidades del antropometrista, en el seguimiento de los
procedimientos establecidos para el trabajo de campo y en el conocimiento y dominio
del programa de cómputo para la captura de la información, entre otros aspectos.
La calidad de la información obtenida y el éxito del proyecto se basan en un excelente desempeño en campo del
antropometrista.
Funciones y responsabilidades del antropometrista
La función principal del antropometrista es aplicar los procedimientos establecidos
en cada medición, en el 100% de los adultos seleccionados. Esta función se logra con
las siguientes acciones a seguir:
Garantizar la calidad de los procedimientos realizados y el completo llenado de la
información, exceptuando los casos en los que se indique la omisión de algunas
mediciones.
Emplear habilidades y estrategias de convencimiento para evitar el rechazo a realizar
las mediciones.
Recopilar toda la información requerida en el tiempo destinado para cada localidad.
En caso de ser necesario, hacer las visitas adicionales necesarias para evitar
ausencia de información.
Estar atento a todas las indicaciones que se le instruyan y ser puntual en todos sus
compromisos de trabajo.
Apoyar otros trabajos comisionados por el supervisor y participar en las reuniones de
revisión que éste organice.
Comunicar al supervisor los avances logrados, así como los percances o dificultades
que pudieran afectar el levantamiento.
5
Reportar inmediatamente al supervisor toda situación anómala o irregular que se
presente durante el trabajo de campo.
Apoyar a sus compañeros de equipo para la conclusión de las actividades previstas
en cada vivienda.
Cuando por algún motivo las mediciones no puedan llevarse a cabo en algún
seleccionado, el antropometrista deberá solicitar la firma de algún integrante del hogar
en un documento donde se especifique la razón, mismo que entregará al supervisor
quien realizará la revisión y verificación correspondientes.
Si no encontrara a alguien en la vivienda y los vecinos o alguna otra persona le
comentaran que la casa está desocupada o que los propietarios están temporalmente
fuera de la localidad, deberá indicarlo en un documento escrito (puede ser en una
hoja en blanco o bien en su bitácora), especificando el nombre y el domicilio de la
persona que le proporcione esta información.
En caso de que requiera hacer aclaraciones durante el vaciado de información, el
sistema dispone de una sección de “Observaciones” que podrá abrir en cualquier
momento, para especificar claramente la causa o circunstancia por la que se realiza la
observación.
Por otra parte, la responsabilidad primordial del antropometrista es realizar cada
procedimiento con excelente calidad. Para lograr este objetivo se deben tener en
cuenta los siguientes principios:
Calidad. La excelente calidad está determinada fundamentalmente por la aplicación
correcta de las técnicas, procedimientos y la cobertura alcanzada de acuerdo con la
selección de la muestra.
6
Productividad. Es de suma importancia el cumplimiento de los estándares de
productividad del levantamiento. Esto requiere la toma total de las mediciones en el
tiempo establecido; de ahí la necesidad de cumplir con las cargas de trabajo en los
periodos acordados.
Confidencialidad. Se debe guardar estricta confidencialidad sobre la información
obtenida en cada hogar. A través de la carta de consentimiento los antropometristas
notificaran a los informantes que la información obtenida no será revelada a otras
personas.2
Respeto. El entrevistador debe mostrar respeto en todo momento hacia las
tradiciones de la zona y hacia los diversos grupos de personas que habitan en ella.
Otra de las responsabilidades de suma importancia del antropometrista es devolver
todos los materiales de trabajo al finalizar el operativo de campo, principalmente de
la computadora portátil (PC Laptop) que le haya sido asignada, así como el equipo
para cada medición (Estadímetro, Báscula, y Hemocue, etc.). En caso contrario, se
deberá presentar por escrito la justificación correspondiente, el acta administrativa, el
acta judicial o realizar el pago respectivo.
2
Conforme a las disposiciones del Artículo 38 de la Ley de Información Estadística y Geográfica en
vigor, “Los datos e informes que los particulares proporcionen para fines estadísticos o provengan de
registros administrativos o civiles, serán manejados, para efectos de esta LEY, bajo la observancia de
los principios de confidencialidad y reserva y no podrán comunicarse, en ningún caso, en forma
normativa o individualizada, ni harán prueba ante autoridad administrativa o fiscal, ni en juicio o fuera
de él.”
7
Lineamientos generales para el levantamiento
Procedimientos para un levantamiento de calidad
La recopilación de la información de las mediciones antropométricas y biológicas
se realizará mediante la aplicación de los procedimientos a los adultos de 50 años y
más seleccionados en el estudio y de ser el caso de sus respectivos cónyuges. Para
lograr un resultado de calidad, es importante que los antropometristas cumplan con lo
siguiente:
Tener claros los objetivos del levantamiento. Es común que las personas
entrevistadas pidan información acerca de lo que se busca con las mediciones, por lo
que antes de salir a campo es necesario conocer los antecedentes conceptuales del
proyecto y resolver cualquier duda al respecto.
Realizar las mediciones con los informantes e ingresar los datos cuidadosamente
en el programa de cómputo.
Nota: Es sumamente importante realizar las mediciones con toda la privacidad
posible, pues la presencia de otras personas puede influir en el informante y, en
consecuencia, se corre el riesgo de no obtener las mediciones.
Mostrar la credencial de acreditación como personal del Instituto Nacional de
Salud Pública (INSP) y portarla en un lugar visible. Esta acción representa un
respaldo para la confianza del adulto.
Propiciar un ambiente favorable. Existe una gran cantidad de grupos humanos que
tienen diversas maneras de concebir y organizar su vida. Este hecho, asociado con
las diferentes personalidades de cada individuo, obligan a poner en práctica toda la
habilidad y sensibilidad del antropometrista para establecer un ambiente de confianza
y privacidad durante la toma de las mediciones.
8
Todos
los
antropometristas
deben
seguir
uniformemente
los
anteriores
procedimientos, de esta manera, se logrará la homogeneidad en el trabajo de
campo, característica básica para que éste adquiera validez y que la información
obtenida pueda ser analizada en su conjunto y con un alto nivel de veracidad y
precisión.
9
Presión arterial
Concepto
La Presión Arterial (PA) se refiere a
la fuerza que produce la sangre sobre las
arterias, al pasar por ellas. Las arterias son vasos sanguíneos que llevan sangre
desde el corazón hacia todo el cuerpo. La sangre a su vez transporta el oxigeno y los
nutrientes
a
todos
los
órganos
del
cuerpo
para
que
puedan
funcionar
La presión arterial se compone de dos cifras:
La máxima o sistólica que es cuando el corazón bombea la sangre.
La mínima o diastólica en el momento que el corazón se relaja.
La presión alta o hipertensión arterial se define como una elevación continua o
intermitente de la presión de la sangre, ya sea diastólica o sistólica. Cuando la presión
arterial es alta, empieza a dañar los vasos sanguíneos, el corazón y los riñones. Esto
puede provocar un ataque al corazón, un ataque cerebral, enfermedades de los
riñones y otros problemas.
Cifras normales
Se considera como valor normal 120/80 mm/hg en adultos. Sin embargo, estas cifras
pueden variar dependiendo de la constitución física, edad y sexo del individuo, por lo
que para considerar una presión normal debemos preguntar a la persona si conoce el
valor de su presión arterial, puesto que algunos mantienen presiones bajas sin tener
ningún problema. Se considera hipertensión arterial cuando la presión sistólica es
mayor a 140 mm de Hg y la presión diastólica es mayor de 90 mm de Hg.
10
Equipo y material
Baumanómetro electrónico (OMRON)
Pilas AA
Lápiz o pluma
Bitácora de registro
Tarjeta de resultados
•
Se realizarán dos mediciones.
•
Preparar el baumanómetro, es decir instalar la manguera del brazalete al
baumanómetro del lado izquierdo y encender el botón azul de ON/OFF.
•
En la parte inferior izquierda de la pantalla aparece el nombre Systolic
(Sistólica) y Diastolic (Diastólica), al encender la pantalla aparece con la cifra
688 en cada una de ellas y en el apartado de pulso aparece la cifra 188 y el
reloj marcador del tiempo
•
Explicar al adulto el procedimiento que se le va a realizar.
•
Pedir al adulto que se siente y que se descubra el brazo izquierdo, en caso que
no pueda hacerlo solo, ayúdelo.
•
Pedirle que se retire, anillos, reloj, pulseras etc.
•
Debe ponerse cómodo, en posición sentado en una silla con brazos o junto a
una mesa, de tal manera que permita colocar el brazo bien extendido y a la vez
mantenerlo apoyado para facilitar la medición.
•
Localizar el pulso humeral con los dedos índice y medio, ajustar el brazalete de
tal manera que la manguera no se obstruya y quede sobre el trayecto de la
arteria.
•
Colocar el brazalete alrededor del brazo, a dos centímetros por arriba del codo.
•
Verifique que el brazalete tenga contacto con la piel sin apretar.
11
•
Una vez colocado el brazalete correctamente, se oprime el botón gris de
START el insuflará el brazalete y una vez que deje de descender la
numeración, inmediatamente después aparecerá el valor, mismo que deberá
registrarlo.
•
Retirar el brazalete del brazo del adulto.
Nota: Antropometrista recuerde que para realizar la segunda toma de presión arterial,
el adulto tiene que permanecer sentado por 5 minutos.
Baumanómetro digital
Puntos antropométricos
La antropometría
La antropometría es una técnica amigable y poco costosa, portátil y aplicable en todo
el mundo para evaluar el tamaño, las proporciones y la composición del cuerpo
humano. Refleja el estado nutricional y de salud y permite predecir el rendimiento, la
salud y la supervivencia. Como tal, es un instrumento valioso en la orientación de las
políticas de salud pública y las decisiones clínicas.
12
Es la técnica sistematizada de medir y realizar observaciones en el cuerpo humano,
en el esqueleto, que describe las diferencias cuantitativas de las medidas del cuerpo
utilizando métodos adecuados y científicos. La amplitud de las observaciones y
medidas está limitada únicamente por la naturaleza de los problemas a los cuales se
aplica; en consecuencia, las reglas, divisiones, medidas e índices tienen en todo
momento carácter “convencional”.
Son las maniobras en las cuales se obtiene el peso en kilogramos, la talla de pie, la
talla sentado y las circunferencias de cintura, cadera y talón-rodilla en centímetros,
por mencionar algunas.
Nota general
Los puntos antropométricos que a continuación se describen serán realizados 2
veces, en caso necesario de duda o margen de error se realizara una 3ra medición.
Peso
Concepto
Es la resultante de la acción que ejerce la gravedad sobre un cuerpo. (Las variaciones
que pueda haber en observación son debidas al sexo, edad del individuo y muchos
otros factores).
Es la medida de valoración nutricional más empleada, en concepto de peso, es un
indicador de masa corporal total necesaria para detectar en combinación con la talla
alteraciones en el estado nutricional tales como obesidad o desnutrición
13
Equipo y material
-
Una báscula estándar
-
Una tara de 5kg.
-
Toallas de papel
-
Lápiz o pluma
-
-
Para adultos se utilizarán básculas portátiles electrónicas digitales con precisión de
100g. El peso máximo que registra la báscula es de 150.0 Kg.
El funcionamiento y calibración de la báscula deberá revisarse con la ayuda de
taras (5Kg.) para estar seguros de que va a dar pesos exactos.
14
Indicaciones generales para peso
Explicar al adulto el procedimiento que se le va realizar.
Pedirle que se quede con el mínimo de ropa aceptable y que se quite los zapatos y
objetos pesados que sobreestimen el peso como pueden ser: llaves, monedas,
cinturones con hebillas gruesas, chamarras o suéteres, chalecos pesados etc.
Evitar pesarlos con ropa pesada o húmeda, mujeres con cabello largo mojado.
•
Indicar antes de proceder a pesar, si tienen el pantalón muy largo pedirle o
realizarle el doblez hacia arriba, de tal manera que pueda observar los talones
y punta de los pies de la persona los cuales deben de permanecer dentro de
los bordes de la bascula y tener buena visión de la pantalla.
•
Cuando sea posible, evacuar la vejiga. Nunca debe pesarse después de haber
realizado una comida abundante.
•
Pedir al adulto que de un solo paso se suba a la báscula como lo indica la
imagen siguiente.
Nota
Sólo se ayudará a subir a la báscula a los adultos con alguna discapacidad.
En caso de que la iluminación sea insuficiente, utilice una lámpara de mano para
poder observar el resultado.
15
Talla
Concepto
Es la distancia tomada en posición vertical, de pie desde el suelo al vértex o punto
más alto del cráneo.
El estado enfermizo o saludable de los individuos está en íntima relación con la talla,
siendo los principales factores la genética y la nutrición.
Equipo y material
-
Estadímetro
-
Lápiz o pluma
-
Sanitas
-
-
Tarjeta de resultados.
•
Explicar al individuo el procedimiento que se le va a realizar.
•
Se busca dentro o fuera de la casa un lugar donde el piso se encuentre lo más
plano posible, debe tener un ángulo de 90°, se colo ca la base del estadímetro
para ensamblar las partes de la regleta graduada.
•
Verificar que al unir las partes de la regleta, la numeración sea de menor a
mayor.
•
Asegúrese de que las partes de la regleta estén bien unidas y que las figuras
geométricas coincidan, es decir, debe unir (☼ con ☼), (◘ con ◘) y (◙ con ◙).
•
Introduzca el tope superior y colóquelo de tal manera que la ventanilla con las
flechas queden del lado de la numeración.
16
•
Introduzca la columna en la base de plástico asegurándose que esté
totalmente dentro de la ranura de la base y que la numeración quede del lado
izquierdo.
•
Indique a la persona que se quite los zapatos.
•
Para los casos que tengan pantalones muy largos, realice el doblez hacia
arriba, de tal manera que pueda observar los talones y pies de la persona.
•
En caso de peinados altos (chongos, coletas, diademas), indíquele que se los
quite.
•
Solicite a la persona que se coloque de espalda a la columna numérica en
posición recta con los brazos a los costados, corrobore que los talones,
pantorrillas, glúteos, espalda y cabeza queden pegados a la columna y los pies
ligeramente separados haciendo un ángulo de 45° gra dos, sin que la persona
se recargue.
•
La línea media del cuerpo deberá coincidir con la línea media del estadímetro.
•
La cabeza debe estar alineada con respecto al cuerpo, derecha y pegada a la
columna, el punto de referencia que se considera es el vértex (o el punto más
alto del cráneo) y la barbilla debe estar centrada y paralela al suelo.
•
Con la mano izquierda tome la barbilla del sujeto a fin de controlar la cabeza y
orientarla hacia el plano de Frankfurt (se refiere a una línea imaginaria que se
marca entre la órbita inferior del ojo y el cartílago prominente del oído medio)
con la mano derecha deslizará el tope móvil hasta tocar la parte coronal de la
cabeza formando un ángulo de 90°.
17
Cabeza en posición del Angulo de Frankfurt
Posición erguida
•
Asegúrese que la posición sea la correcta.
•
Después realice la lectura de la talla que está indicada con las flechas que
vienen marcadas en la ventanilla del tope movible del estadímetro; la lectura
deberá tomarse del lado izquierdo de la persona y en forma horizontal para
precisar la lectura.
•
Se registrará la talla en el programa de captura, bitácora
y tarjeta de
resultados.
Ejemplo: Estatura
165.2=/_1_/_6_/_5_/./_2_/
Centímetros
•
mm
Los pies marcados deben de quedar centrados
en medio de la base del
estadímetro (figura 1)
18
Figura 1
posición correcta para medir la talla
Circunferencia de Cintura
Concepto
La circunferencia de la cintura y cadera son ampliamente utilizados como indicadores
de obesidad abdominal en estudios sobre factores de riesgo vasculares y
metabólicos. También está claro que una gran circunferencia de cintura es el mejor
indicador de grasa intra-abdominal, de grasa visceral y de los factores de riesgo a que
conlleva esto.
Equipo y Material
-
Cinta métrica de fibra de vidrio.
-
Lápiz o pluma
-
-
Condiciones generales para la toma de las circunferencias.
Colocar y marcar el punto anatómico de referencia
Colocar la cinta métrica en circunferencia
19
La cinta no debe de hacer presión y no debe de estar doblada
La lectura debe de tomarse en centímetros y milímetros
Técnica de medición
•
El adulto deberá estar relajado de frente dejando desnuda la zona en que se
tomara la medida, los brazos cruzados y descansados sobre los hombros, sin
zapatos.
•
Se palpa el borde costal inferior y el borde superior de la cresta iliaca de ambos
lados y la ultima costilla flotante de ambos costados para identificar el punto
medio.
•
Con la cinta métrica se toma la distancia media axilar y después se hace lo
mismo del lado izquierdo.
•
Una vez marcada la media en los 2 lados con un bolígrafo, se coloca la cinta
sin comprimir alrededor de la cintura dejando visible el cero de la cinta para
medir la circunferencia y vigilando que la cinta se encuentre horizontal sin
dobleces, tome la lectura correspondiente. Recuerde que la medición se lee en
centímetros y milímetros.
•
Evite que sus dedos queden entre la cinta métrica y el cuerpo del adulto, ya
que esto conduce a tomar una lectura errónea.
•
Se realizará 2 veces la medición para que esta sea más precisa y en caso que
tenga duda entre la primera y segunda para corroborar
se realizara una
tercera medición.
20
Circunferencia de cadera
Concepto
Es un indicador que evalúa la distribución de tejido adiposo alrededor de la extensión
más grande de las nalgas.
Equipo y Material
-
-
Lápiz o pluma
-
-
Técnica de medición
•
El adulto deberá permanecer de pie con los pies separados unos 20 cm y con
el peso distribuido en forma pareja
sobre ambos pies descalzos y con la
menor ropa posible.
•
Esta circunferencia se toma horizontalmente en el nivel de máxima extensión
de los glúteos.
•
La medida se realiza en la parte más grande o voluminosa de los glúteos.
•
La evaluación se puede efectuar en el nivel de los trocánteres.
•
El antropometrista adoptara una posición junto al adulto de tal modo que pueda
ver el nivel de extensión máxima de los glúteos y colocar la cinta alrededor de
estos en un plano horizontal.
•
La cinta debe estar pegada a la piel pero se debe de procurar no comprimir
demasiado.
•
La lectura deberá realizarla del lado izquierdo del individuo, esto para evitar
malos entendidos.
21
Medición de la Altura de la Rodilla
Concepto
Son las maniobras que se realizan para tomar la medición de la distancia entre la
rodilla y el talón en centímetros
Punto tibial lateral (Tíbiale Laterale). Es el punto más proximal y lateral o externo de
la extremidad proximal de la tibia (platillo tibial externo). Con él se pueden determinar
la longitud del muslo, la altura tibial, el perímetro del muslo en su 1/3 medio.
Equipo y Material
-
-
Lápiz o pluma
-
-
•
Nota: antes de proceder a realizar la medición, se le pedirá al adulto que se
descubra la pierna 3 dedos arriba de la rodilla hasta la altura del muslo, en
caso de que este tenga algún impedimento físico, se le ayudara a realizar esta
maniobra
•
Se mide la distancia entre el talón y la parte más alta de la articulación de la
rodilla, por la parte lateral externa, con la pierna flexionada con el adulto
sentado y formando un ángulo de 90° entre el muslo y la pantorrilla
•
Colocado el antropometrista delante del adulto, pedirle que flexione la rodilla
formando un ángulo de 90º y/o se sentará para facilitar la localización del
punto.
•
Este punto se localiza buscando, en primer lugar, con el dedo pulgar o índice,
la depresión o la interlínea articular de la rodilla, rodeada por tres
protuberancias (epicóndilo femoral, borde anterolateral de la tibia y la cabeza
del peroné); en segundo lugar, y a partir de esta orientación, el antropometrista
22
presiona hacia dentro con la cara lateral del pulgar de la mano derecha hasta
localizar el borde de la tibia y, por último, se palpará hacia atrás hasta localizar
el punto anatómico coincidente con la zona más proximal y externa de la
meseta tibial. Este punto está al menos a un tercio de la distancia entre el
punto anterior y posterior de la rodilla.
•
Una vez identificado el punto anatómico, el sujeto se coloca nuevamente en
bipedestación realizándose la marca justo en el lugar en que el dedo o la uña
del pulgar o el índice sienten el borde tibial descrito, comprobándose, como
siempre, que está correctamente señalado.
•
Debe medir, de ser posible en la pierna izquierda con el adulto sentado, sin
zapatos y con la rodilla en ángulo recto (en personas encamados se debe
poner la pierna en ángulo de 90°)
•
Medir la distancia entre la mano puesta encima de la rodilla y el punto de
contacto del talón con el suelo. Siguiendo una línea recta que debe pasar por
el maléolo externo
•
Redondear la medida en 0.5 cm.
•
Registrar el resultado.
Altura de la medicion de la rodilla
23
Medición de Altura Sentado
Concepto
Distancia entre el vértex y el plano de sustentación del entrevistado, medida en cm y
milímetros.
Equipo y Material
-
Fléxometro.
-
Escuadra
-
Lápiz o pluma
-
-
•
Es la distancia que existe entre el vértex y los puntos inferiores de la pelvis
(ambos isquion), que se apoyan en el banco.
•
Normalmente, esta medida se debería efectuar con el adulto sentado en una
silla y con los pies descalzos y pegados al piso en una superficie plana.
•
Se orienta la cabeza del sujeto en el Plano de Frankfort, se le pide que esté
sentado lo más erguido que pueda, tocando con la zona alta de la espalda y
parte posterior de la cabeza en la pared y formando un ángulo de 90º con los
muslos, al igual que la articulación de la rodilla y las manos apoyadas en los
muslos.
•
Se registra la medición en su bitácora, recuerde que son centímetros y
milímetros.
•
Se le invita a levantarse del banco.
•
Este procedimiento se realizará a cada uno de los adultos 2 veces. Si surgiera
alguna duda entre la primera medición y segunda se realiza una tercera para
confirmación.
24
Medidas de Desempeño
La estimación de la capacidad funcional es importante en la evaluación de las
personas en edad avanzada; por lo general se determina esa capacidad en términos
de las actividades cotidianas, como caminar, vestirse y comer. También pueden
efectuarse diversas pruebas funcionales como la fuerza del apretón, el tiempo
necesario para caminar 3 metros y la capacidad para mantenerse en pie sobre una
sola pierna. Estas pruebas son buenos elementos predictivos de la independencia de
la función general y en general se relacionan con la masa corporal y la masa
muscular.
Se piensa que un estado nutricional deficiente y las alteraciones de la composición
del cuerpo se asocian con crecientes problemas del equilibrio y la marcha en las
personas de edad avanzada y, por lo tanto, con el riesgo de sufrir caídas
Antropometrista es importante que las instrucciones para las siguientes pruebas
sean claras y precisas para que el adulto pueda realizarlas, recuerde que de ninguna
manera debe el adulto sentir que está siendo evaluado.
25
Ahora haremos algunos ejercicios para medir su movilidad. Le voy a mostrar cómo
hacer el siguiente ejercicio. Me gustaría que usted tratara de hacerlo. Si cree que no
puede o cree que es peligroso para usted le ruego que me lo diga.
Estando de pié, por favor intente pararse en un solo pié sin apoyarse o agarrarse de
ninguna cosa. Puede intentarlo con cualquiera de sus piernas; después probaremos
con la otra.
Voy a contar el tiempo, así le avisaré cuándo empezar y cuando terminar (DIEZ
SEGUNDOS). Podemos parar en cualquier momento que usted sienta que pierde el
equilibrio.
Comencemos con la pierna con la que se sienta más seguro(a)
Registro de resultados
Se va a registrar el tiempo que el adulto logre permanecer parado en un solo pie tanto
para el pie izquierdo como para el derecho, en caso de que no realice la prueba se
debe de registrar el código que corresponda de acuerdo sea el caso del resultado de
la prueba.
26
Velocidad de la Marcha
Ahora voy a observar como camina usted normalmente. Si usted usa un bastón u otra
ayuda para caminar y siente que la necesita para caminar un recorrido corto, puede
usarla.
Para esta prueba vamos a buscar un espacio adecuado en donde se pueda realizar
este ejercicio.
Equipo y Material
-
Listón de 3 metros de largo
Cronometro (reloj)
Indicaciones:
Primera Prueba de Velocidad al caminar
Este es nuestro recorrido. Le pediré que usted camine hasta el final del
recorrido a su velocidad acostumbrada, tal como si estuviera caminando en la
calle para ir a la tienda.
Muestre el recorrido al participante.
27
Camine todo el recorrido hasta que pase a la otra orilla de la cinta antes de
parar. Yo caminaré con usted. ¿Usted siente que esto es seguro?
Pida al participante que se ponga de pie con los dos pies tocando la línea de
inicio.
Cuando quiera que comience, yo diré: “Listo, empiece.” Cuando el participante
reconozca esta instrucción diga: “Listo, empiece.”
Presione el botón de empezar para iniciar el cronómetro mientras que el
participante empieza a caminar.
Camine detrás y hacia un lado del participante.
Pare de tomar el tiempo cuando uno de los pies del participante esté
completamente al otro lado de la línea.
3 metros
Se va a registrar el tiempo que el adulto logre pasar uno de los 2 pies completamente
al otro lado la línea de termino del listón, en caso de que no realice la prueba se debe
de registrar el código que corresponda de acuerdo a los códigos de resultado de la
28
pregunta1.18
Tiempo para recorrer 3 metros
1.17 Tiempo de la Primera
Prueba
[___|___] .
Min
[___|___]
[___][___] . [___][___]
> 0 pase a 1.19
seg.
Si no pudo realizar la prueba
anote…….00 00
Trató, pero no pudo…………………………………..…...1
1.18 Si el participante no El participante no pudo mantener
intentó o falló en la prueba, su posición sin ayuda..…………………….…………….2
indique el motivo:
No intentó, usted se sintió inseguro.................3
No intentó, el participante se sintió inseguro....4
El participante no pudo entender
las instrucciones..………………………………….……..5
Pase
a 1.23
[____]
Otro (Especifique)_________________.........6
1.19. Ayudas para el primer
recorrido
Rehusó hacerla..................................................7
Ninguna…........1
Bastón …..........2
Otra…..............7
[____]
B. Segunda Prueba de Velocidad al caminar
Ahora le pediré que repita el recorrido. Recuerde que debe caminar a su ritmo
acostumbrado, y siga hasta que pase al otro extremo del recorrido.
Pida al participante que se ponga de pie con los dos pies tocando la línea de
inicio.
Cuando yo quiera que comience, yo diré: “Listo, empiece.” Cuando el
participante reconozca esta instrucción diga: “Listo, empiece.”
Presione el botón de empezar para iniciar el cronómetro mientras que el
participante empieza a caminar.
Camine detrás y hacia un lado del participante.
Pare de tomar el tiempo cuando uno de los pies del participante esté
completamente al otro lado de la línea.
29
Se va a registrar el tiempo que el adulto logre pasar uno de los 2 pies completamente
al otro lado la línea de termino del listón, en caso de que no realice la prueba se debe
de registrar el código que corresponda de acuerdo a los códigos de resultado de la
pregunta 1.21
Prueba de la Fuerza de Presión.
Introducción
La fuerza en las manos afecta las funciones de la vida diaria como el levantar objetos o
cuerpos pesados y normalmente esta fuerza declina con la edad.
Ahora evaluaremos la fuerza de su mano al apretar un objeto. Voy a pedirle que apriete
un objeto tan fuerte como pueda hacerlo, sólo por un par de segundos y luego soltarlo.
Realizaremos la prueba con su mano derecha y su mano izquierda.
Equipo y Material
-
Dinamómetro
-
Este equipo se utiliza para medir la fuerza en kilogramos del adulto mayor, realizando
esta prueba en 2 diferentes tiempos, como se muestra en la siguiente imagen:
30
Instrucciones
Le mostraré como hacerlo
•
Sugiera al informante que se quite sus anillos u otras joyas similares.
•
Usando la mano dominante del informante ajuste el dinamómetro al
entrevistado -de vuelta a la barra para moverla hacia arriba o hacia
abajo- de manera que la barra se apoye en la parte media del dedo
índice y del dedo anular
•
En posición de píe, mantenga el dinamómetro en un ángulo de 90° y
apriete el mango durante unos segundos.
•
Verifique que el informante esté en la posición correcta: de pie y
formando con el brazo un ángulo de 90°.
•
Verifique que el dinamómetro marque cero.
•
Explique el procedimiento nuevamente.
•
Permita que el informante practique con su mano dominante. Si el
informante no puede usar su mano dominante, practique con la otra
mano y espere 30 segundos entre cada prueba.
•
Este procedimiento se deberá realizar 2 veces en cada mano.
31
ENTREVISTADOR:
Verifique la respuesta de la pregunta 1.23. Si la respuesta es código “1” realice 1.26 y
1.27; si la respuesta es código “2” realice 1.27 y si la respuesta es código “3” realice
sólo 1.26
PRIMERA MEDICIÓN
1.26. Haremos dos
mediciones con la
mano izquierda
1.27. Haremos dos
mediciones con la
mano derecha
[____][____].[____] kg
SEGUNDA MEDICIÓN
[__][__].[__] kg
[____][____].[____] kg
Intentó pero no pudo….. 993.0
Intentó pero no pudo. 993.0
No lo intentó………………..999.0
No lo intentó...………....999.0
[____][____].[____] kg
[__][__].[__]kg
[____][____].[____] kg
Intentó pero no pudo….. 993.0
Intentó pero no pudo. 993.0
No lo intentó…….………..999.0
No lo intentó...…….…..999.0
[__][__].[__] kg
[__][__].[__] kg
32
Obtención de Muestras de Sangre Capilar
Sangre capilar: También denominada periférica, es transportada a través de
capilares los cuales son vasos sanguíneos finísimos, interpuestos a través de cuyas
paredes se producen los intercambios entre sangre y tejidos. La piel fría y cianótica es
una fuente de error, esto se evita dando un masaje a la piel hasta que esté rosada y
caliente antes de la punción. La punción se hará preferiblemente en el borde libre del
pulpejo del dedo anular pues resulta más cómodo y accesible. No deberá hacerse en
una parte edematosa o congestionada, ya que es esencial que la sangre pueda fluir
libremente para obtener resultados reproducibles que se puedan comparar con los de
la sangre venosa. Una vez que la punción esté hecha, debe evitarse frotar y exprimir
fuertemente porque también da origen a error.
Equipo y material General
- Sanitas
- Guantes
- Torunderos
- Torundas impregnadas con alcohol y secas
- Portalancetas (softclix)
- Lancetas
- Contenedor de desechos punzo cortantes
- Bolsas rojas para desechos tóxicos RPBI (torundas y guantes)
- Bolsa negra para deshechos no tóxicos (envoltura de guantes, sanitas, etcétera)
33
Determinación de Hemoglobina Glucosilada
Concepto
La hemoglobina es una proteína que lleva los glóbulos rojos o hematíes. El azúcar de
la sangre se une a la hemoglobina para formar la hemoglobina A1 (glucosilada).
Si la sangre contiene más azúcar, la hemoglobina glucosilada aumenta y permanece
aumentada durante 120 días. Por esto, la medición de la hemoglobina glucosilada
refleja todas las altas y bajas de glucosa en la sangre en las pasadas 12 semanas.
La hemoglobina A1 es un promedio del nivel de azúcar en los últimos meses,
mientras que un examen para azúcar en la sangre (glucosa) sólo indica el estado de
control de diabetes en un punto determinado.
Material especifico
-
El equipo de A1CNOW consta de:
-
A1CNOW Monitor.
-
Sobre 1: Kit de dilución de la muestra
-
Micropipeta Pasteur
-
Recolector capilar
-
Criobial con solución
-
Porta criobial
-
Sobre 2: Cartucho de prueba
-
Cartucho
•
Coloque el material y el equipo A1CNOW de forma accesible sobre las sanitas,
las cuales estarán sobre una superficie plana y segura.
•
Arme el soporte para el críotubo y colóquelo cerca del A1CNOW.
•
Tenga a la mano la pipeta para la recolección de la gota.
34
•
Quite el capuchón del portalancetas y coloque la lanceta presionando para
fijarla, una vez fija, gire hasta quitar el recubrimiento de la lanceta y coloque la
capucha del portalancetas hasta escuchar un clic.
•
En caso que el lugar de punción este frio, pedirle al adulto que sede masajes
en las manos para calentar la zona, esto nos permitirá que obtengamos una
buena gota
•
Aseo del sitio de punción. Se realiza la asepsia con una torunda impregnada
con alcohol sobre la cara lateral del pulpejo del dedo anular o medio de
preferencia de la mano que utilice menos, con el fin de quitar la suciedad, el
detritus epitelial y para aumentar la cantidad de sangre en este sitio.
•
Deje secar el residuo de alcohol. Cuide que el lugar de punción esté
completamente seco, esperando durante algunos segundos, ya que, de lo
contrario, la sangre no formará una gota redondeada al salir.
•
Coloque el portalancetas cargado sobre la cara lateral del dedo y ejerza una
ligera presión sobre la zona elegida para la punción; el disparo de la lanceta
será automático, espere de 2 a 3 segundos antes de retirar el portalancetas.
•
Coloque la mano en declive para facilitar la salida de gota de sangre, sin tocar
el dedo y evitando exprimir para no diluir la muestra con líquido de los tejidos y
liberar mas glucosa.
•
Esta gota se absorberá colocando la micropipeta de tal manera que la punta
absorba la gota de sangre evitando no tocar la piel a una distancia suficiente
del dedo y cuidando que sea lo suficientemente grande, de manera que se
llene hasta la línea negra y no contenga burbujas de aire para obtener un
resultado óptimo; si esto ocurre, se tendrá que repetir el procedimiento de
recolección.
•
Limpie cuidadosamente con una torunda seca el exceso de sangre localizada
alrededor de la pipeta.
•
Introduzca la pipeta en el críotubo y de un sólo golpe presione, deje caer la
gota de sangre, saque la pipeta, cierre bien el críotubo y realice de 6 a 8
inversiones vigorosas para diluir la sangre con la sustancia.
35
•
Una vez realizada la inversión, coloque el críotubo en la base y destápelo
cuidadosamente.
•
Inmediatamente inserte el cartucho en el equipo de A1CNOW.
•
Con la segunda pipeta de burbuja, procederá a extraer la sustancia,
inmediatamente traslade la cantidad recolectada al equipo A1CNOW y
presione vigorosamente la pipeta en el círculo de color blanco que viene en el
centro del cartucho sin salirse del él. Recuerde en todo momento que la pipeta
debe estar llena hasta la marca indicada y sin burbujas; si se llega a regar, esto
puede marcar error, por lo que se tendrá que repetir el procedimiento.
•
Debe recordar que el equipo cuenta sólo con 10 reactivos, por lo tanto, se
debe tener el cuidado necesario para evitar desperdiciar este material.
Nota: El equipo tiene que mantenerse en temperatura ambiente de 18-28C°. En caso
que la temperatura sea menor, se debe proceder a calentar el cartucho frotándolo o
guardándolo en un lugar caliente para activar el reactivo. Si la temperatura es mayor,
debe conseguirse una hielera y gel congelante para conservar la temperatura.
.
Tome la muestra de sangre capilar. Ponga la muestra en el críotubo.
36
Agite vigorosamente 6-8 veces. Inserte el cartucho y agregue la muestra.
37
Determinación de hemoglobina
Concepto
Hemoglobina es el componente principal de los glóbulos rojos, del 31% al 34 %, es
una proteína de la sangre que se encarga de transportar el oxígeno desde los
órganos respiratorios hasta los tejidos. Es posible identificar a la hemoglobina como
una heteroproteína ya que es una proteína conjugada (combina una parte proteica
denominada globina con una parte no proteica que se conoce como grupo
prostético).
La técnica de Hemocue es usada ampliamente en estudios de campo, por su facilidad
de hacer las mediciones in situ, sin necesidad de preparar y conservar las muestras.
Es muy reproducible y su precisión u exactitud son muy buenas comparadas con
mediciones de Hb hechas en laboratorio con métodos de citometría de flujo. La
concentración de hemoglobina se obtiene en unidades de gr/dl.
Material especifico
-
Hemocue
-
Pilas AA
-
Cargador de luz
-
Microcubeta reactiva
-
-
•
Coloque su material y el Hemocue de forma accesible sobre las sanitas, las
cuales estarán sobre una superficie plana y segura.
38
•
Muestre al Adulto que el equipo que va a utilizar está limpio y que las lancetas
son nuevas y no han sido utilizadas en ocasiones anteriores.
•
Cargar el portalancetas. Destape la punta del portalancetas y coloque una
lanceta presionando para fijarlo, una vez fija, gire hasta quitar el recubrimiento
de la lanceta y coloque nuevamente la parte superior del portalancetas hasta
escuchar un clic.
•
Aseo del sitio de punción. Se realiza la asepsia con una torunda impregnada
con alcohol sobre la cara lateral del pulpejo del dedo anular o medio de
cualquiera de las manos, con el fin de quitar la suciedad, el detritus epitelial y
para aumentar la cantidad de sangre en este sitio.
•
Deje secar el residuo de alcohol. Cuide que el lugar de punción esté
completamente seco, esperando durante algunos segundos, ya que, de lo
contrario, la sangre no formará una gota redondeada al brotar.
•
Técnica de punción. Coloque el portalancetas cargado sobre la cara lateral del
dedo y ejerza una ligera presión sobre la zona elegida para la punción; el
disparo de la lanceta será automático. Enseguida retire el portalancetas.
•
La primera gota de sangre. Coloque la mano en declive para facilitar la salida
de una primera gota de sangre, al mismo tiempo que la absorberá para la
prueba de hemoglobina glucosilada, sin tocar el dedo y evitando exprimir o
ordeñar para no diluir la muestra con líquido de los tejidos.
•
Coloque la segunda gota de sangre en la microcubeta especial para medir
hemoglobina en el Hemocue. Esta gota se absorberá colocando la cubeta de
tal manera que la punta absorba la gota de sangre, evitando no tocar la piel a
una distancia suficiente del dedo, colocando la zona de color de la cubeta del
Hemocue y cuidando que sea lo suficientemente grande, de manera que se
llene completamente la cubeta y no contenga burbujas de aire para obtener un
resultado óptimo.
•
Limpie cuidadosamente con una torunda seca el exceso de sangre localizada
alrededor de la microcubeta.
39
•
Introduzca la microcubeta en el Hemocue (encendiendo previamente el botón
que se encuentra en la parte superior izquierda después de la pantalla),
coloque la cubeta llena en el sitio del portacubeta del Hemocue y
posteriormente
presione
hacia
dentro
para
obtener
la
medición
de
hemoglobina. Para evitar mediciones erróneas, la cubeta debe permanecer en
esta posición mientras no aparezca el resultado en la pantalla lo que tarda de
15-45 segundos.
•
Forma de riesgo de resultados de hemoglobina. La cifra de hemoglobina que
aparece en la pantalla digital del Hemocue deberá ser registrada
por el
antropometrista en la sección de registro de mediciones biológicas.
•
Retirar la cubeta de la ranura y pulsar la tecla para apagar el equipo.
•
Desechar la lanceta, torundas utilizadas, guantes y microcubeta que se usó
para la cuantificación de hemoglobina en el recipiente especial destinado para
cada uno de ellos.
Precauciones para la determinación de hemoglobina
En el momento de la punción se saca la microcubeta, extraer únicamente una
a la vez.
Nunca dejar destapado el tubo de Microcubetas de Hemocue.
Nunca tocar la zona del reactivo de la microcubeta con los dedos.
Cuando el tubo se ha abierto, se debe poner la fecha ya que tiene 90 días para
usarse después de ser destapado.
No destapar un tubo nuevo hasta que el anterior se haya terminado por
completo.
Limpiar semanalmente con una torunda humedecida en alcohol o agua
destilada el área de lectura del equipo, cuidando de no dejar pelusa ni raspar
nada; deje secar todas las partes, introduzca la porta microcubeta
completamente en el aparato.
40
Cuando aparecen las tres rayas fijas en el fotómetro indica que está en proceso de
lectura
Microcubeta obtención de sangre
41
Coloque la cubeta en el soporte para la lectura
El resultado se visualiza después de 15 a 45 segundos
42
Toma de Muestra Sanguínea
Introducción
La determinación del estado de salud de los adultos mayores debe incluir mediciones
de laboratorio, en este estudio se considera la medición de:
Colesterol Total y Colesterol de Lipoproteínas de Alta Densidad (HDLc). El
HDL es el colesterol bueno llamado así porque es factor de "protección" del
sistema cardiovascular.
La Proteína C-reactiva (PCR), es un biomarcador del sistema inmunológico, el
marcador más comúnmente utilizado para medir inflamación e infección.
Además a sido ampliamente utilizado para estudiar la asociación de PCR con
arteriosclerosis, diabetes tipo 2 y enfermedad cardiovascular.
Vitamina D. Además de ser un indicador de la salud ósea, en los últimos años
el déficit de vitamina D se ha vinculado con algunos tipos de cáncer, con la
función muscular y con el equilibrio entre otros.
TSH (Hormona estimulante de tiroides). La forma más común de disfunción
tiroidea en las personas de mayor edad es el hipotiroidismo subclínico. Los
riesgos potenciales del hipotiroidismo subclínico en los ancianos incluyen la
progresión a hipotiroidismo clínico, efectos cardiovasculares, hiperlipidemias, y
efectos neurológicos
Por otra parte, la obtención adecuada de una muestra sanguínea permite realizar
análisis de ella satisfactoriamente, por lo cual es de suma importancia llevar a cabo
este procedimiento lo más seguro, rápido, y fácilmente posible. Es importante, para
garantizar la calidad de la muestra que ésta sea correctamente colectada, que su
origen sea seguro y que los procedimientos de preparación y conservación sean
estrictamente observados (reposo, centrifugado, pipeteo y etiquetado) y que se
conserve adecuadamente hasta su llegada al laboratorio, donde se harán las
determinaciones.
43
El personal que lleva a cabo este procedimiento debe tener presente que el éxito del
trabajo encomendado depende de sus conocimientos, el trato correcto con los sujetos
de estudio y la habilidad para realizar el trabajo.
Equipo y material
-
Ligadura de látex
-
Guantes de látex
-
Tubo Vacutainer de tapón rojo
-
Aguja Vacutainer
-
Aguja Vacutainer verde mariposa
-
Aguja Vacutainer azul mariposa
-
Sanitas
-
Torunderos
-
Torundas con alcohol y secas
-
Termo individual
-
Gradilla
-
Gel congelante
-
Contenedor de desechos punzo cortantes chico
-
Contenedor de desechos punzo cortantes grande
-
Bolsa negra de deshechos
-
Bolsa roja RPBI
-
Etiquetas (Blancas o impresas) para identificación de la muestra
-
Marcador indeleble
-
44
Técnica para Extracción Venosa
•
El adulto no necesariamente debe de estar en ayuno la muestra se tomara
casual, es decir a la hora que se encuentre al seleccionado.
•
Deberá seleccionar un área adecuada, cómoda y con buena iluminación dentro
del hogar para la toma de muestra.
•
Se debe explicar que procedimiento que se le realizará al adulto, para hacerlo
sentir seguro.
•
Deberá permanecer sentado de forma que el este cómodo y para la enfermera
sea accesible la toma de muestra.
•
se prepara el campo y se acomoda el material necesario para la toma de
muestra, explique que el material es nuevo, completamente estéril y muestre al
adulto la aguja en el momento que la destapa.
•
Pídale al adulto que le muestre su antebrazo de ambos brazos, para checar
que vena y brazo son los adecuados para la toma (Ver figura 1), lugar de
donde se recomienda obtener la muestra de sangre.
Figura 1. Venas superficiales del brazo:
1Cefalica, 2 Basílica, 3 Media Basílica, 4 Media Cefálica, 5 Radial accesoria,
6 Cubital superficial y 7 radial superficial
45
•
Debe palpar con la punta de los dedos índice y medio la vena para checar el
grosor y la trayectoria de la misma.
•
Una vez seleccionado el sitio de punción, aplica un torniquete de 7 a 8 cm por
arriba del pliegue del codo. No se debe de dejar el torniquete por más de 3
minutos (porque esto ocasiona hemolisis) y se recomienda que se le pida al
adulto que cierre el puño para resaltar más las venas.
•
Se realiza la asepsia en la zona de punción, debe realizarla del centro a la
periferia y de arriba hacia abajo, rotando su torunda alcoholada. Se deja secar
la zona y no se toca ya.
•
Se fija firmemente la vena, con los dedos índice y pulgar distendiendo la piel
del lugar de punción.
•
Se realiza la venopunción utilizando el sistema vacutainer y
se penetra a
través de la piel con la aguja formando un ángulo de aproximadamente 15° a
30°, con el brazo y con el bisel hacia arriba sigui endo la dirección de la vena. El
tubo se introduce en el dispositivo (la camisa vacutainer), al tener ya la
presencia de sangre en el mismo, se retira el torniquete. Esperar que el tubo se
llene (6ml de sangre total).
NOTA: Este paso es importante ya que necesitamos una buena toma para obtener
suero no hemolizado. Recuerde en todo momento que para realizar una buena toma
debe elegir la aguja de acuerdo al grosor de la vena del adulto seleccionado, además
si acepto la toma de muestra para ADN debe tomar el segundo tubo.
46
•
Una vez realizado el procedimiento hay que indicar al adulto que relaje el puño
y se retira el tubo.
•
Colocar sobre el sitio de la punción una torunda seca al mismo tiempo que se
retira la aguja con suavidad (la torunda deberá de permanecer entre uno y tres
minutos sobre el sitio de la venopunción).
•
Debe rotar de 3 a 5 veces ligeramente la muestra.
•
Debe de etiquetar adecuadamente su tubo con el folio que le correspondiente
al adulto seleccionado.
•
En todo momento debe estar al pendiente del estado en el que se encuentra el
adulto, esto porque en algunas ocasiones puede marearse al ver la sangre o al
retirar la aguja etc.
Precauciones Generales.
El material siempre debe estar a su alcance.
Debe estar al pendiente del individuo para evitar que se mueva, se pare
o bien se desmaye, ya que estas situaciones traen como consecuencia
accidentes tales como:
Que se rompa la aguja
Que se salga la aguja y haya sangrado
Que se ocasione un hematoma
Debe pedir al familiar que no haya niños pequeños esto por que en
ocasiones andan corriendo y pueden movernos.
Figura 2. Ejemplo de toma de muestra con sistema Vacutainer®.
47
Procedimiento Después De La Toma De Muestra Sanguínea
•
La muestra de sangre total debe conservarse a una temperatura de 2° a 8° C.
•
Todas las muestras recolectadas deberán de ser centrifugadas antes de 30
min. y a 2500 RPM durante 15 a 20 minutos.
•
Se obtendrá solo el suero del tubo, observar que no se encuentre hemolizado.
•
El suero obtenido se separara en 2 alícuotas de 2.00 ml. cada una.
•
El coaguló será depositado en el contenedor de punzo cortantes Grande
•
Una vez separado y teniendo una cantidad de sueros debe depositarlos al
tanque de Nitrógeno.
•
El tanque de Nitrógeno no debe abrirse continuamente puesto ocasiona la fuga
del mismo liquido.
•
Cuando el tanque de Nitrógeno está en su capacidad deberá de ser
trasladados al laboratorio del Instituto Nacional de Salud Publica a Cuernavaca
o donde oficina central lo indique.
48
Diagrama de flujo de la antropometría
TOMA 1 DE PRESIÓN ARTERIAL
MEDICION DE ALTURA SENTADO
1Y2
MEDICION RODILLA-TALON 1 Y 2
MEDICION PANTORRILLA 1 Y 2
TOMA 2 DE PRESIÓN ARTERIAL
MEDICION DE TALLA 1
MEDICION DE TALLA 2
MEDICION DE PESO 2
MEDICION DE PESO 1
MEDICION DE CINTURA 1
MEDICION DE CINTURA 2
MEDICION DE CADERA 1
MEDICION DE CADERA 2
PRUEBA DE BALANCE
PRUEBA DE MARCHA
PRUEBA DE FUERZA
DE PRESIÓN
PRUEBA DE
HEMOGLOBINA.
GLUCOSILADA
TOMA DE MUESTRA DE
SANGRE VENOSA
49
Bibliografía.
Secretaria de Salud. Manual de procedimientos. Toma de medidas clínicas y
antropométricas en el adulto mayor. Subsecretaria de Prevención y Protección para la
Salud.
México
2002.
Disponible
en:
http://www.salud.gob.mx/unidades/cdi/documentos/DOCSAL7518.pdf
Teresa Shamah Levy, Salvador Villalpando Hernández, Juan Rivera Dommarco.
Manual de Procedimientos para proyectos de nutrición. México. Instituto Nacional de
Salud
Pública.
Diciembre
2006.
Disponible
en:
http://www.salud.gob.mx/unidades/cdi/documentos/proy_nutricion.pdf
Organización Mundial de la Salud. El estado físico: Uso e Interpretación de la
antropometría. Informe de un Comité de Expertos de la OMS. OMS, Ginebra. 1995.
Disponible
en:
http://www.who.int/childgrowth/publications/physical_status_es/en/index.html
Brull DJ, Serrano N, Zito F, Jones L, Montgomery HE, Rumley A, et all. Human CPR
gene polymorphism influences CRP levels: Implications for the predictions and
pathogenesis of coronary heart disease. Arterioscler Thromb Vasc. Biol, 2003; 23(11);
2063-2069. PMID: 12842840
Cristina Estefanell, Rocío Olivera, et all. Desafíos de la vitamina D. Nuevas propuestas
de suplementación. Arch Pediatr Urug 2010; 81(4): 248-250.
50
Manual of Procedures Anthropometrics and Biological Sample
Apéndice I. Biomarcadores
I.
Descripción de la muestra
Se analizaron en total 2.016 muestras distribuidas en cuatro estados. La base de
datos bruta con los resultados de los biomarcadores incluye a los sujetos que
forman parte de la muestra previamente entrevistada por el Instituto Nacional
de Estadística Geografía Informática (INEGI), también incluye a 13 sujetos
que participaron únicamente en la toma de muestra de sangre pero no forman
parte de la muestra entrevistada por el INEGI.
El Cuadro 1.1 incluye los identificadores a nivel hogar (CUNICAH), sub-hogar
(SUBHOG_12), e individual (NP) de los sujetos que completaron las muestras
de sangre pero no la entrevista completa con el ENASEM.
Cuadro 1.1. Sujetos que sólo completaron la muestra de sangre
ID del Hogar:
CUNICAH (=UNHHID)
3567
7992
7995
8015
9506
9513
10771
10801
10943
13042
13107
13110
14624
ID del Sub-Hogar:
SUBHOG_12
1
1
1
1
1
11
11
11
1
0
0
0
0
ID Individual:
NP
10
20
10
10
20
11
11
10
10
10
10
10
10
51
Los siguientes resultados descriptivos incluyen la muestra total, incluyendo estos
13 sujetos; sin embargo, estos no se incluyen en el archivo de datos final
disponible en la página web del ENASEM www.MHASweb.org.
El Cuadro 1.2 incluye la distribución de los sujetos según la condición de la
muestra de sangre al momento del análisis de los biomarcadores .
Cuadro 1.2 Distribución de los sujetos de acuerdo a la condición de la
muestra de sangre
Tipo de
muestra
Sin
observaciones
Lipémica
Ligeramente
lipémica
Hemolizada
Ligeramente
hemolizada
Total
No parte de la
muestra del
ENASEM
Frecuencia
%
Muestra del
ENASEM
Frecuencia
%
Total
Frecuencia
%
11
84.62
1,571
78.43
1,582
78.47
2
15.38
384
19.17
386
19.15
0
0.00
1
0.05
1
0.05
0
0.00
37
1.85
37
1.84
0
0.00
10
0.50
10
0.50
13
100.00
100.00
2,016
100.00
2,003
Se consultó con el INSP sobre la conveniencia de incluir en el análisis las
muestras lipémicas y hemolizadas. La siguiente es su opinión respecto a las
diferencias entre los tipos de muestras:
1.
El número de muestras hemolizadas no representa un serio problema, ya
que es relativamente pequeño. Dado que las muestras hemolizadas son la
excepción, y representan un pequeño número dentro de una muestra grande
(menos de 2%), se recomienda considerar incluir el total de la muestra en los
análisis.
52
2.
En cuanto al análisis del colesterol total y el HDL, es importante tener en
cuenta que la condición de sueros lipémicos puede ser resultado de una
hiperlipidemia o a que no ayunaron. Así mismo, dado que el colesterol total y el
HDL son biomarcadores interpretables en condiciones de no ayuno, los
resultados de los sueros lipémicos deben ser analizados con precaución.
53
II.
Resultados de Colesterol Total (CT)
Para el total de 2,016 muestras analizadas el valor promedio del Colesterol Total
fue de 200,6 mg/dL.
Biomarcador
CHOLESTEROL_mg_dL
N
2,016
Media
200.65
DE
Mínimo
46.68 78.00
Máximo
528.00
Los resultados que a continuación se presentan considera los puntos de corte
que recomienda la NORMA Oficial Mexicana NOM-037-SSA2-20023 para la
prevención, tratamiento y control de las dislipidemias.
TC mg/dL
Recomendable
Limítrofe
Alto riesgo
< 200
200-239
≥ 240
El Cuadro 2.1 muestra la distribución de los resultados de Colesterol Total de
acuerdo a los puntos de corte incluidos anteriormente. Los resultados indican
que 57,6% de la muestra presenta valores recomendables de Colesterol Total,
27% se encuentra dentro del límite y 15,3% tiene valores de alto riesgo.
Cuadro 2.1 Colesterol Total (CT) mg/dL
< 200
200 a 239
≥ 240
Total
Frecuencia Porcentage
1,161
57.6
546
27.1
309
15.3
2,016
100.0
Los resultados incluidos en el Cuadro 2.2 indican que el Estado 2, tiene el mayor
porcentaje de personas con nivel de colesterol de alto riesgo (19,4%).
3
http://www.salud.gob.mx/unidades/cdi/nom/037ssa202.html
4
El nombre de los 4 estados se eliminó para proteger la identidad de los entrevistados.
54
Cuadro 2.2 Resultados de Colesterol Total por Estado4
Estado
Estado 1
Estado 2
Estado 3
Estado 4
Total
< 200 mg/dL
Fr
%
201
59.1
305
52.4
196
61.4
459
59.2
1,161
57.6
200 to 239 mg/dL
Fr
%
98
28.8
164
28.2
82
25.7
202
26.1
546
27.1
≥ 240 mg/dL
Fr
%
41
12.1
113
19.4
41
12.9
114
14.7
309
15.3
Total
340
582
319
775
2,016
Los resultados por estado y genero en la Figura 2.1, indican que el porcentaje de
sujetos con niveles de colesterol de alto riesgo es similar entre hombre y
mujeres . En la Figura 2.1, los resultados por estado y de género indican que el
porcentaje de sujetos con niveles de colesterol alto riesgo es similar entre
hombres y mujeres, en 3 estados, a excepción del Estado 3, donde la diferencia
es de 8,1 puntos porcentuales mayor en mujeres que en hombres .
Figura 2.1 Resultados de Colesterol Total por Género y Estado
80
68.3
70
60
58.0
59.6
55.9
59.9
57.0
59.0
Estado 3
Estado 4
50.0
50
40
30
20
10
0
Estado 1
Estado 2
Estado 3
Estado 4
Estado 1
Hombres
Colesterol <200 mg/dL
4
Estado 2
Mujeres
Colesterol 200-239 mg/dL
Colesterol >=240 mg/dL
55
Las estadísticas descriptivas por grupo de edad en el Cuadro 2.3 indican que el
mayor porcentaje de personas dentro de los niveles recomendados de colesterol
se encuentra entre la cohorte más joven. Por otra parte, el porcentaje más bajo
de personas con niveles de colesterol de alto riesgo se encuentra entre la
cohorte más joven (91 %), el porcentaje casi se duplica entre el grupo de 51 a 60
años (17,8 %), y es más alto para la cohorte de más edad de 61 años y mayores
(14,5 %).
Cuadro 2.3 Resultados de Colesterol Total por Grupo de Edad
Colesterol
mg/dL
< 200
200 to 239
≥ 240
Total
≤ 50
%
64.5
26.4
9.1
100.0
Edad
51 a 60
%
51.9
30.3
17.8
100.0
61 y más
%
60.7
24.8
14.5
100.0
Total
%
57.7
27.1
15.3
100.0
56
III.
Resultados Colesterol HDL (C-HDL)
Para el total de 2,016 muestras analizadas el valor promedio del HDL fue de
41,20 mg/dL. A diferencia de los valores anteriores, niveles de HDL altos son
más beneficiosos y niveles bajos son perjudiciales para la salud.
Biomarcador
HDL mg/dL
N
2,016
Media
41.20
DE
10.40
Mínimo
17.00
Máximo
92.00
La NORMA Oficial Mexicana NOM-037-SSA2-2012, para la prevención,
tratamiento y control de las dislipidemias recomienda los siguientes puntos de
corte para la valoración y para el Colesterol de lipoproteínas de alta densidad (CHDL).
Recomendable
Alto Riesgo
> 35
≤ 35
HDL mg/dL
Los resultados que se muestran en el Cuadro 3.1 indican que el Estado 3 tiene
el mayor porcentaje de personas con niveles fuera del rango recomendado para
el HDL (37,0 %).
Cuadro 3.1 Resultados de HDL por Estado5
Estado
Estado 1
Estado 2
Estado 3
Estado 4
Total
5
≤ 35 mg/dL
Fr
%
108
31.8
165
28.4
118
37.0
236
30.5
627
31.1
> 35 mg/dL
Fr
%
232
68.2
417
71.6
201
63.0
539
69.5
1,389
68.9
Total
340
582
319
775
2,016
57
La Figura 3.1 indica que el porcentaje de personas con niveles de alto riesgo de
HDL es mayor para los hombres en comparación con las mujeres. En el Estado
1 la diferencia es de 20,9 puntos porcentuales, mientras que en los estados
restantes la diferencia oscila entre 11,9 y 13,6 puntos porcentuales.
Figure 3.1 Resultados de HDL por Género y Estado
90
76.7
80
70
62.3
55.8
50
55.6
44.4
44.2
37.7
36.4
40
74.2
67.9
63.6
60
77.2
32.1
30
23.3
25.8
22.8
20
10
0
Estado 1 Estado 2 Estado 3 Estado 4 Estado 1 Estado 2 Estado 3 Estado 4
Hombres
Mujeres
HDL > 35
HDL =< 35
El Cuadro 3.2 incluye los resultados de los niveles de HDL por grupos de edad.
Los resultados indican que el mayor porcentaje de las personas con niveles de
alto riesgo de HDL se encuentra entre las personas de 60 años y más (32,5 %).
Cuadro 3.2 Resultados de HDL por Grupo de Edad
HDL mg/dL
≤ 35
> 35
Total
≤ 50
29.9
70.1
100.0
Edad
51 a 60
29.7
70.3
100.0
60 y más
32.5
67.5
100.0
Total
31.1
68.9
100.0
58
IV.
Resultados de Proteína C Reactiva (PCR)
Para el total de 2,016 muestras analizadas el valor promedio del PCR fue de
4,25 mg/dL.
Biomarcador
C-Reactive Protein mg/dL
N
Media
DE
Mínimo
2,016
4.26
7.20
0.00
La valoración de los resultados de PCR considera los lineamientos de la
American Heart Association6 (Asociación Estadounidense de Cardiología) y los
del laboratorio LAMARKT7, los cuales establecen:
•
Se encuentra en bajo riesgo de desarrollar enfermedad cardiovascular si
el nivel de PCR está por debajo de 1,0 mg/dL
•
Se
encuentra
en
riesgo
promedio
de
desarrollar
enfermedad
cardiovascular si los niveles están entre 1,0 y 3,0 mg/dL
•
Se encuentra en alto riesgo de desarrollar enfermedad cardiovascular si el
nivel de PCR está por encima de 3,0 mg/dL
PCR mg/dL
Bajo riesgo
Riesgo promedio
Alto riesgo
< 1.0
1.0-3.0
3.0
Los resultados de PCR por estado indican que el Estado 1 (47,9 %) y el Estado
4 (45 %) tienen los mayores porcentajes de las personas con niveles de PCR de
alto riesgo.
6
7
http://www.nlm.nih.gov/medlineplus/spanish/ency/article/003356.htm
http://www.microelisas.com/pdf/PCR%20us%20CLIA%20%20Monobind.pdf
59
Cuadro 4.1 Resultados de Proteína C Reactiva por Estado8
< 1 mg/dL
Fr
%
67
19.7
107
18.4
79
24.8
143
18.5
396
19.6
Estado
Estado 1
Estado 2
Estado 3
Estado 4
Total
1 a 3 mg/dL
Fr
%
148
43.5
196
33.7
124
38.9
283
36.5
751
37.3
≥ 3 mg/dL
Fr
%
125
36.8
279
47.9
116
36.4
349
45.0
869
43.1
La Figura 4.1 muestra que la proporción de mujeres con niveles de alto riesgo de
la PCR es sistemáticamente superior a la proporción de hombres. En el Estado
4, la diferencia es de 16 puntos porcentuales, mientras que en el Estado 3 la
diferencia es de 10,2 puntos porcentuales, 7,8 en el Estado 1, y 5,3 en el Estado
2.
Figura 4.1 Resultados de Proteína C Reactiva por Género y Estado
60
54.2
50
40
46.3
39.4
38.9
42.4
38.9
28.5
27.2
40.6
39.9
38.8
34.9
32.1
30
51.6
35.9
30.4
35.1
30.0
26.4
23.4
22.2
20
13.8
15.7
13.3
10
0
Estado 1
Estado 2
Estado 3
Hombres
CRP <1 mg/dL
Estado 4
Estado 1
CRP 1 a 3 mg/dL
Estado 2
Estado 3
Estado 4
Mujeres
CRP >=3 mg/dL
8
60
El Cuadro 4.2 incluye los resultados de los niveles de PCR por grupos de edad.
Los resultados indican que los adultos jóvenes tienen el mayor porcentaje de las
personas con niveles de alto riesgo del CRP (48,2 %).
Cuadro 4.2 Resultados de Proteína C Reactiva por Grupo de Edad
PCR
mg/dL
<1
1 to 3
≥3
Total
≤ 50
23.4
28.4
48.2
100.0
Edad
51 a 60
17.7
38.3
44.0
100.0
60 y más
20.5
38.1
41.4
100.0
Total
19.7
37.2
43.1
100.0
61
V.
Resultados de Hormona Estimulante de Tiroides (TSH)
Para el total de 2,0159 muestras analizadas el valor promedio del TSH fue de
2,88 uIU/mL.
Biomarcador
TSH uIU/mL
N
2,015
Media
2.88
DE
5.55
Mínimo
0
Máximo
100
Los siguientes son los valores de referencia para la Hormona Estimulante de
Tiroides (TSH) establecidos en la Guía de Referencia Rápida10 para el
diagnóstico y Tratamiento de hipotiroidismo primario en adultos. Aunque el
diagnóstico de hipotiroidismo (primario, secundario o subclínico) requiere tanto
de la determinación de la hormona estimulante de tiroides como de la Tiroxina
Libre (T4), solo se proporcionan valores de TSH.
Hipotiroidismo
secundario
TSH
<0.1
Normal
0.1-4.49
Hipotiroidismo
Hipotiroidismo
subclínico
primario
4.5-10.0
>10 & <40
Los resultados de TSH por estado, en el Cuadro 5.1, indican que el Estado 3
tiene los porcentajes más altos de personas con hipotiroidismo subclínico y
primario, 12,6% y 3,8% respectivamente.
9
Los resultados de TSH no fueron obtenidos para 1 sujeto porque la muestra de sangre no era suficiente.
10
http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/265_IMSS_10_Hipotiroidismo_Primario/GRR_IMS
S_262_10.pdf 62
Cuadro 5.1 Resultados de TSH por Estado11
<0.1 uIU/mL
Estado
Fr
2
9
2
5
18
Estado 1
Estado 2
Estado 3
Estado 4
Total
%
0.6%
1.5%
0.6%
0.6%
0.9%
0.1-4.49
uIU/mL
Fr
%
295 86.8%
522 89.7%
264 83.0%
687 88.6%
1,768 87.7%
4.5-1.0
uIU/mL
Fr
%
33 9.7%
39 6.7%
40 12.6%
70 9.0%
182 9.0%
>10 & <40
mg/dL
Total
Fr
%
10 2.9%
340
12 2.1%
582
12 3.8%
318
13 1.7%
775
47 2.3% 2,015
Los resultados por estado y género, en la Figura 5.1, indican que el porcentaje
de sujetos con hipotiroidismo subclínico y primario es mayor para las mujeres
comparado con los hombres, a excepción del Estado 1.
Figure 5.1 Resultados de TSH por Género y Estado
100
90
85.5
91.5
87.6
91.1
84.9
87.1
81.8
80
70
60
50
40
30
22.0
20
10
14.5
17.2
15.1
11.4
9.8
7.2
12.1
8.6
0.0
1.0
1.3
1.7
0.0
1.0
0.3
0.8
Estado 1
Estado 2
Estado 3
Estado 4
Estado 1
Estado 2
Estado 3
Estado 4
0
Hombres
CRP <.1 uIU/mL
Mujeres
CRP .1-4.49 uIU/mL
CRP >=4.5 uIU/mL
11
63
El Cuadro 5.2 incluye los resultados de los niveles de TSH por grupos de edad.
Los resultados indican que el grupo de adultos jóvenes tienen el mayor
porcentaje de personas con nivel de TSH normal: 89,80% para los adultos de 50
años o menores y 89.22 para los adultos de 51 a 60 años de edad, en
comparación con 86,17 para los adultos de 60 años o más.
Cuadro 5.2 Resultados de TSH por Grupo de Edad
TSH uIU/mL
<0.1
.1 to 4.49
4.5 to 1.0
>10 & <40
Total
≤ 50
1.02
89.80
7.14
2.04
100.00
Edad
51 a 60
0.90
89.22
7.83
2.05
100.00
60 y más
0.87
86.17
10.35
2.62
100.00
Total
0.90
87.71
9.06
2.61
100.00
64
VI.
Resultados de Vitamina D
Para el total de 2,01312 muestras analizadas el valor promedio del TSH fue de
24,21 ng/dL.
Biomarcador
Vitamina D ng/dL
N
2,016
Media
24.21
DE
8.62
Mínimo
4.7
Máximo
92.3
Los siguientes son los puntos de corte para Vitamina D, parte de las directrices
para la evaluación de la deficiencia de Vitamina D.
Vitamina D ng/dL
Deficiencia
Normal
<20
≥20
Los resultados en el Cuadro 6.1 indican que el Estado 1 tiene el mayor
porcentaje de personas con deficiencia de vitamina D (54,7%), seguido por el
Estado 2 (36,8%).
Cuadro 6.1 Resultados de Vitamina D por Estado13
≥ 20 ng/dL
Total
Fr
%
Estado 1
154
45.3%
340
Estado 2
368
63.2%
582
Estado 3
222
70.0%
317
Estado 4
620
80.1%
774
Total
1,36
67.8% 2,013
4
La Figura 6.1 indica que el porcentaje de personas con deficiencia de vitamina D
Estado
< 20 ng/dL
Fr
%
186
54.7%
214
36.8%
95
30.0%
154
19.9%
649
32.2%
es consistentemente más bajo para los hombres en comparación con las
12
13
Los resultados de Vitamina D no fueron obtenidos para 3 sujetos porque la muestra de sangre no era suficiente.
65
mujeres; la diferencia oscila entre 4,4 (en el Estado 4) y 25,7 puntos
porcentuales (en el Estado 3).
Figura 6.1 Resultados de Vitamina D por Género y Estado
85.6
90
80
82.8
78.4
72.9
70
60.4
60
50
81.8
56.6
53.6
46.4
39.6
40
43.3
40.1
27.1
30
20
21.6
17.2
14.4
10
0
Estado 1
Estado 2
Estado 3
Estado 4
Estado 1
Estado 2
Hombres
Estado 3
Estado 4
Mujeres
Vitamina D <20 ng/mL
Vitamina D >=20 ng/mL
El Cuadro 6.2 incluye los resultados de los niveles de Vitamina D por grupos de
edad. Los resultados indican que el mayor porcentaje de personas con
deficiencia de vitamina D se encuentra entre las personas de 60 años y más
(38,0%).
Cuadro 6.2 Resultados de Vitamina D por Grupo de Edad
Vitamina D
ng/dL
< 20
≥ 20
Total
≤ 50
27.5
72.5
100.0
Edad
51 a 60
25.8
74.2
100.0
60 y más
38.0
62.0
100.0
Total
32.2
67.8
100.0
66
Apéndice II. Nota Técnica sobre el Método de Análisis de
Laboratorio para la Determinación de Colesterol
Se recibieron un número de muestras de suero que no fueron tomadas en ayuno
y algunas con evidencia de grasa en la muestra (lipémicas). De acuerdo con las
normas del equipo Architect usado para las determinaciones, las muestras
fueron centrifugadas, con lo cual se formó una capa de grasa en la parte
superior del tubo (ver figura 1 anexa), de dimensiones variables y que parte fue
absorbida por la pipeta del brazo del robot del equipo, con lo cual las mediciones
se vieron afectadas.
Figura 1. Efecto de la Centrifugación sobre los Lípidos y el Pipeteo del
Robot
Adicionalmente, a petición de la Dra. Mara Téllez-Rojo se centrifugaron 12
muestras que mostraban niveles muy altos de colesterol. Una vez que se
revisaron estos resultados, se analizó el procedimiento utilizado para la medición
67
inicial. Una vez hecho este análisis se decidió repetir todas el análisis de todas
las muestras “sin centrifugación” para que no apareciera la capa de grasa y se
distribuyera en la muestra. Se repitió análisis de las 12 muestras de sangres, se
volvieron a medir y se compararon con un segundo método más drástico que
consiste en calentar la muestra a 38°C durante 5 min para asegurar que la grasa
se disuelva y no presente mayor trabajo para medirla. Este método no se usa
comúnmente en las muestras de suero, ya que afecta otras substancias las
cuales podrían ser medidas más tarde.
La línea azul en la Figura 2 representa las mediciones hechas después de la
centrifugación, las cuales muestran resultados más altos y menos variabilidad en
comparación con las otras tres líneas. Las línea roja y verde representan las
mediciones hechas sin centrifugación; y, finalmente, la línea azul con la 'x'
representa las mediciones realizadas después de calentar la muestra. Como se
puede observar en la figura, las mediciones que no fueron centrifugadas son
altamente comparables y tienen mayor variabilidad en contraste con la línea que
representa las mediciones después de la centrifugación
68
Figura 2. Análisis de 12 Muestras (enviadas para verificación por la Dra.
Téllez)
COLESTEROL mg/dL
Para asegurar la calidad de las mediciones, se midieron de manera simultánea
sueros de control de calidad, en cantidad doble de lo habitual. Las muestras de
control de calidad se incluyeron al principio del análisis, y se intercalaron cada
50 muestras y al final del análisis. Como se indica en las mediciones que se
presentan en un gráfico de Levy-Jennings a continuación, los resultados
entregados son de buena calidad. Se utilizaron los criterios de Westgard para
interpretar los resultados de control de calidad, los cuales establecen que el
medio determinado por la fabricación no debe exceder de ± 1 desviación
69
estándar (DE). Las Figuras 3 y 4 muestran los resultados de suero sanguíneo de
acuerdo con el criterio establecido por las directrices en Merck Colesterol 2015;
la primera figura presenta una concentración media de 101 mg / dL y la segunda
presenta una concentración media de 242 mg / dL. Los resultados indican que la
diferencia en las mediciones de control de calidad no exceden mas de ± 1 SD.
Figura 3. Curvas de Levy-Jennings. Suero control de calidad Merck
Colesterol #2015, lote 14431, con concentración teórica de 101 mg/dL.;
corridas en varias mediciones entre el 5 y el 16 de Febrero 2015.
70
Figure 4. Curvas de Levy-Jennings. Suero control de calidad Merck
Colesterol #2015, lote 14431, con concentración teórica de 242 mg/dL.;
corridas en varias mediciones entre el 5 y el 16 de Febrero 2015.
71
Conclusiones
Se analizaron de nuevo todas las 2.016 muestras sin el método de
centrifugación. Los resultados ‘corregidos’ que se presentan aquí, son buenas
mediciones según lo confirmado por los resultados de control de calidad que se
presentaron
anteriormente.
Sin
embargo,
estas
muestras
no
fueron
originalmente tomadas en ayuno, lo cual no cumple con la recomendación de la
ATP II, que recomienda un mínimo de 12 horas de ayuno y el punto de corte
internacional >200 mg/dL para diagnóstico de hipercolesterolemia.
Finalmente, en la siguiente tabla se comparan los resultados de prevalencia de
hipercolesterolemia con los de ENSANUT 2012 y los de la ENASEM. Como se
puede ver, los resultados indican que la prevalencia de la hipercolesterolemia es
similar en ambos estudios.
Tabla 1. Comparación de Prevalencias de Colesterol, ENASEM y ENSANUT
2012
Edad
<30
31-40
41-50
51-60
61-70
71-80
>81
Colesterol
> 200 mg/dL (%)
ENASEM 2012
23.81
36.65
39.56
34.12
45.32
38.26
34.86
ENSANut 2012
19.7
27.9
37.9
36.7
42.1
56.8
33.2
72
Apéndice III. Material de Instrucciones de Architect®
En la siguiente tabla se enumeran los contenidos de los materiales incluidos
en el Apéndice III. Cada paquete contiene la información utilizada por el
laboratorio para realizar los ensayos.
Colesterol …………………………………
Page 74
Ultra HDL (UHDL) …………………………
Page 81
CRP Vario ………………………………….
Page 88
TSH …………………………………………. Page 97
TSH Controles ……………………………… Page 104
TSH Calibradores ….………………………. Page 105
25-OH Vitamin D …………………………… Page 106
73
CHOLESTEROL
7D62-20
30-3126/R3
CHOLESTEROL
This package insert contains information to run the Cholesterol assay on the ARCHITECT c Systems™ and the
AEROSET System.
NOTE: Changes Highlighted
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed
accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in
this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
Call your local Abbott representative
Symbols in Product Labeling
Calibrators 1 and 2
Catalog number/List number
Concentration
Serial number
Authorized Representative in the
European Community
Consult instructions for use
Ingredients
Manufacturer
In vitro diagnostic medical device
Temperature limitation
Batch code/Lot number
Use by/Expiration date
Reagent 1
ABBOTT LABORATORIES
Abbott Park, IL 60064, USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories
1
NAME
WARNINGS AND PRECAUTIONS
CHOLESTEROL
Precautions for Users
INTENDED USE
1.
2.
3.
4.
5.
The Cholesterol assay is used for the quantitation of cholesterol in
human serum or plasma.
SUMMARY AND EXPLANATION OF TEST
Measurement of serum cholesterol levels can serve as an indicator of
liver function, biliary function, intestinal absorption, propensity toward
coronary artery disease, and thyroid function. Cholesterol levels are
important in the diagnosis and classification of hyperlipoproteinemias.
Stress, age, gender, hormonal balance, and pregnancy affect normal
cholesterol levels.1
The Adult Treatment Panel of the National Cholesterol Education
Program (NCEP) recommends that all adults 20 years of age and
over should have a fasting lipoprotein profile (total cholesterol, LDL
cholesterol, HDL cholesterol, and triglyceride) once every five years to
screen for coronary heart disease risk.2
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum and plasma are acceptable specimens. The National Cholesterol
Education Program (NCEP) recommends using fasting specimens.2
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
Separate serum from red blood cells or gel as soon after collection
as possible.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
• Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin (with or without gel barrier) and sodium heparin. Ensure
centrifugation is adequate to remove platelets. Separate plasma from
red blood cells or gel as soon after collection as possible.
PRINCIPLES OF PROCEDURE
The use of enzymes to assay cholesterol has been studied by many
investigators.3,4 This reagent is based on the formulation of Allain,
et al.5 and the modification of Roeschlau6 with further improvements to
render the reagent stable in solution.
Cholesterol esters are enzymatically hydrolyzed by cholesterol
esterase to cholesterol and free fatty acids. Free cholesterol, including
that originally present, is then oxidized by cholesterol oxidase to
cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide
combines with hydroxybenzoic acid (HBA) and 4-aminoantipyrine to
form a chromophore (quinoneimine dye) which is quantitated at 500 nm.
Methodology: Enzymatic
REAGENTS
Refer to the specimen collection tube manufacturer’s instructions for
processing and handling requirements.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
Reagent Kit
7D62 Cholesterol is supplied as a liquid, ready-to-use, single
reagent kit which contains:
10 x 84 mL
Estimated tests per kit: 3,032
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients
Cholesterol Oxidase (Microbial)
Cholesterol Esterase (Microbial)
Peroxidase (Horseradish)
4-Aminoantipyrine
HBA
For in vitro diagnostic use.
Do not use components beyond the expiration date.
Do not mix materials from different kit lot numbers.
Contains nonsterile bovine serum albumin.
CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials are considered
potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.7 Biosafety Level 28 or other
appropriate biosafety practices9,10 should be used for materials that
contain or are suspected of containing infectious agents.
Specimen Storage
Serum and plasma
Concentration
> 200 U/L
> 500 U/L
> 300 U/L
0.25 mmol/L
10 mmol/L
Temperature
20 to 25°C
2 to 8°C
-20°C
Maximum
Storage
7 days
7 days
3 months
Bibliographic
Reference
11
11, 12
11
Guder et al.11 suggest storage of frozen specimens at -20°C for
no longer than the time interval cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
The Abbott Clinical Chemistry Cholesterol reagent is certified to be
traceable to the National Reference System for Cholesterol, against
the Abell-Kendall reference method in a CDC-Certified Cholesterol
Reference Method Laboratory Network (CRMLN).
REAGENT HANDLING AND STORAGE
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
PROCEDURE
Materials Provided
7D62 Cholesterol Reagent Kit
Materials Required but not Provided
Reagent Storage
•
1E65 Multiconstituent Calibrator,
3 x 5 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Unopened reagents are stable until the expiration date when stored at
2 to 8°C.
Reagent stability is 30 days if the reagent is uncapped and onboard.
2
PROCEDURE (Continued)
EXPECTED VALUES
Assay Procedure
Reference Range
For a detailed description of how to run an assay, refer to Section 5 of
Serum/Plasma
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and plasma: Specimens with cholesterol values exceeding
705 mg/dL (18.26 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
Child13
Desirable
Borderline
High
Adult2
Desirable
Borderline
High
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a 1:4
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor.
Range (mg/dL)
Range (mmol/L)
< 170
170 to 199
≥ 200
< 4.40
4.40 to 5.15
≥ 5.18
< 200
200 to 239
≥ 240
< 5.18
5.18 to 6.19
≥ 6.22
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0259.
The National Cholesterol Education Program (NCEP) Adult Treatment
Panel III Report2 recommends the adult classification shown above.
Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must
be multiplied by the appropriate dilution factor before reporting the
result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
Cholesterol is linear up to 705 mg/dL (18.26 mmol/L). Linearity was
verified using Clinical and Laboratory Standards Institute (CLSI) protocol
NCCLS EP6-P.14
Limit of Detection (LOD)
The LOD for Cholesterol is 5.0 mg/dL (0.13 mmol/L). The LOD is
the mean concentration of an analyte-free sample + 2 SD, where
SD = the pooled, within-run standard deviation of the analyte-free
sample. A study performed on an ARCHITECT c System and an
AEROSET System produced an LOD for the Cholesterol assay
of 0.80 mg/dL (0.021 mmol/L).
CALIBRATION
Limit of Quantitation (LOQ)
Calibration is stable for approximately 30 days (720 hours) and is
required with each change in reagent lot number. Verify calibration
curve with at least two levels of controls according to the established
quality control requirements for your laboratory. If control results fall
outside acceptable ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the
Multiconstituent Calibrator package insert.
The LOQ for Cholesterol is 6.2 mg/dL (0.161 mmol/L). The LOQ is the
analyte concentration at which the CV = 20%.
Interfering Substances15
Interference studies were conducted using CLSI protocol NCCLS
EP7-P.16 Interference effects were assessed by Dose Response and
Paired Difference methods, at the medical decision level of the analyte.
Interfering
Substance
Interferent
Concentration
7.5 mg/dL (128 µmol/L)
Bilirubin
15 mg/dL (257 µmol/L)
750 mg/dL (7.5 g/L)
Hemoglobin
1,000 mg/dL (10.0 g/L)
1,000 mg/dL (10.0 g/L)
Intralipid
2,000 mg/dL (20.0 g/L)
1.5 mg/dL (85 µmol/L)
Ascorbate
3 mg/dL (170 µmol/L)
QUALITY CONTROL
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
N
4
4
4
4
4
4
4
4
Target
Observed
(mg/dL) (% of Target)
252.3
91.7
252.3
86.8
241.1
109.5
241.1
111.9
236.1
102.5
236.1
101.9
282.2
98.7
282.2
97.6
Bilirubin solutions at the above concentrations were prepared by
addition of a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition of
hemolysate to human serum pools. Intralipid solutions at the above
concentrations were prepared by addition of Intralipid to human serum
pools. Ascorbate solutions at the above concentrations were prepared
by addition of ascorbic acid to human serum pools.
RESULTS
Precision
Refer to the instrument-specific operations manual for information on
results calculations.
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
The imprecision of the Cholesterol assay is ≤ 3% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-A17
are summarized below.
Control
N
Mean (mg/dL)
Within Run
LIMITATIONS OF THE PROCEDURE
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
Between Run
Between Day
Total
3
SD
%CV
SD
%CV
SD
%CV
SD
%CV
Level 1
80
261.4
1.98
0.8
1.01
0.4
3.36
1.3
4.03
1.5
Level 2
80
129.2
0.78
0.6
1.03
0.8
1.64
1.3
2.09
1.6
TRADEMARKS
SPECIFIC PERFORMANCE CHARACTERISTICS (Continued)
Method Comparison
AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
c System is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.
Correlation studies were performed using CLSI protocol NCCLS EP9-A.18
Serum results from the Cholesterol assay on the AEROSET System
were compared with those from a commercially available enzymatic
methodology.
Serum results from the Cholesterol assay on the ARCHITECT c System
were compared with the Cholesterol assay on the AEROSET System.
N
Y - Intercept
Correlation Coefficient
Slope
Range (mg/dL)*
AEROSET
vs. Comparative
Method
79
0.933
0.993
1.016
70.6 to 416.8
ARCHITECT
vs. AEROSET
101
-0.840
0.993
0.979
39.5 to 687.6
*AEROSET Range
BIBLIOGRAPHY
1. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical
Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:480–5.
2. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
and treatment of high blood cholesterol in adults (Adult Treatment
Panel III). JAMA 2001;285:2486–97.
3. Flegg HM. An investigation of the determination of serum
cholesterol by an enzymatic method. Ann Clin Biochem 1973;10:79–
84.
4. Richmond W. Preparation and properties of a cholesterol oxidase
from Nocardia sp. and its application to the enzymatic assay of total
cholesterol in serum. Clin Chem 1973;19(12):1350–6.
5. Allain CC, Poon LS, Chan CS, et al. Enzymatic determination of
total serum cholesterol. Clin Chem 1974;20(4):470–5.
6. Roeschlau P, Bernt E, Gruber WA. Enzymatic determination of total
cholesterol in serum. Z Klin Chem Klin Biochem 1974;12:226.
7. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Occupational Exposure to
Bloodborne Pathogens.
8. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication
(CDC), 4th ed. Washington, DC: US Government Printing Office,
May 1999.
9. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
10. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
11. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
preanalytical variables. Annex In: Samples: From the Patient to the
Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 12–3.
12. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
13. American Academy of Pediatrics, Committee on Nutrition.
Cholesterol in childhood. Pediatrics 1998:101(1);141–7.
14. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
15. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-143–3-163.
16. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
National Committee for Clinical Laboratory Standards, 1986.
17. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1999.
18. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline (EP9A). Wayne, PA: The National Committee for Clinical Laboratory
Standards, 1995.
4
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Cholesterol Serum/Plasma—Conventional and SI Units
Configure assay parameters — General
● General
Configure assay parameters — SmartWash
о Calibration о SmartWash о Results
о Interpretation
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Chol
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
R1
ALBP0
Water
300
1
Cuvette
Trig
10% Detergent B *** 345
Assay: Chol
Type: Photometric
Version: 1
Number: 1018
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 500 / 660
Main: 31 – 33
Last required read: 33
Absorbance range: ___ – ___
Color correction: ___ – ___
Sample blank type: None
*** Select “Detergent B” for software prior to version 2.2.
Cholesterol Serum/Plasma—Conventional Units
о Reaction definition
Reagent: CHOL0
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STANDARD : 2.4
___
1:4
: 25.0
2.4
_________ : ___
___
Reaction check:
None
● Reagent / Sample о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
___
75
___
Configure assay parameters — Results — Conventional Units
R1
240
___
Type 0
Water Dilution factor
___ =
1:1.00
___ =
1:4.00
___ =
о General
о SmartWash ● Results о Interpretation
Assay: Chol
Result units: mg/dL
Assay defaults:
Low-Linearity:
7†
High-Linearity: 705
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0 – 199
Default
dilution
●
о
о
о Calibration
о Reagent / Sample ● Validity checks
Configure result units — Conventional Units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
Maximum absorbance variation: ___
Configure assay parameters — Calibration
о General
Assay:
● Calibration о SmartWash о Results
Chol
Calibration method: Linear
● Calibrators
Calibrator set:
MCC
Replicates: 3
о Volumes
[Range 1 – 3]
о Calibrators
Calibrator: MCC
Blank:
Cal 1:
Cal 2:
о Intervals
Calibrator level:
Blank: Water
Cal 1: MCC1
Cal 2: MCC2
● Volumes
Calibrator level
Water
MCC1
MCC2
о Calibrators
о Volumes
Calibration intervals:
Full interval: 720
Calibration type:
Adjust type: None
о Calibrators
о Interpretation
Chol
1
mg/dL
0
[Range 0 – 4]
1.0000
0.0000
о Volumes
Blank absorbance range:
Span:
Span absorbance range:
Expected cal factor:
Expected cal factor tolerance %:
о Intervals
Sample
2.4
2.4
2.4
Diluted
sample
___
___
___
● Intervals
Cholesterol Serum/Plasma—SI Units
о Validity checks
Concentration:
0††
‡
‡
Configure assay parameters — Results — SI Units
о General
Assay: Chol
Result units: mmol/L
Assay defaults:
Low-Linearity:
0.17†
High-Linearity: 18.26
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 5.17
о Validity checks
Diluent
___
___
___
Water
___
___
___
о Validity checks
Configure result units — SI Units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
(hours)
о Intervals
_____ – _____
Blank – Blank
_____ – _____
0.00
0
о Calibration
● Validity checks
Chol
1
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.
5
AEROSET SYSTEM ASSAY PARAMETERS
Cholesterol Serum/Plasma—Conventional Units
Cholesterol Serum/Plasma—SI Units
Assay Configuration: Outline Page
Assay Name
Assay #
Chol
18
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
7**
Reference Ranges*
Age
L-Reference-H
0
199
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Assay Name
Assay #
Chol
18
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.17**
Reference Ranges*
Age
Line
B-Line
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
0.0
705
0.0
0.0
0.0
0.0
Max
0.0*
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
B-Line
L-Reference-H
0.00
5.17
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
N/A
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
18.26
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Assay Configuration: Base Page
Reaction Mode
Wavelength-Prim/Sec Read time-Main/Flex
AbsMaxVar
END UP
500 / 660
31 – 33 / 0 – 0
0.0
Sample Blank Test
Blank Read Time Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
25.0
2.4
75
0
Diluent: DILUENT D–18*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CHOL061 – ___*
240
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
0
mg/dL
Reaction Mode
AbsMaxVar
END UP
500 / 660
31 – 33 / 0 – 0
0.0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
25.0
2.4
75
0
Diluent: DILUENT D–18*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CHOL061 – ___*
240
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Assay Configuration: Calibration Page
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.4
C1
MCC 1
2.4
C2
MCC 2
2.4
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Calib Mode
Linear
3/3
Sample
S.Vol
BLK Water
2.4
C1
MCC 1
2.4
C2
MCC 2
2.4
Interval (H)
720
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Interval (H)
720
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Assay Configuration: SmartWash Page
Rgt Probe
Rgt Probe
Reagent
ALBP061
Wash
Water
Vol
300
Assay Name
—
Wash
—
Vol
—
Reagent
ALBP061
Wash
Water
Vol
300
Assay Name
—
Wash
—
Vol
—
Cuvette
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
6
ULTRA HDL
3K33-20
30-4129/R5
ULTRA HDL
This package insert contains information to run the Ultra HDL assay on the ARCHITECT c Systems™ and the
AEROSET System.
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
Symbols in Product Labeling
Calibrator
Concentration
Serial number
Authorized Representative in the
European Community
Ingredients
Manufacturer
Reagent 1
Reagent 2
ABBOTT LABORATORIES
Abbott Park, IL 60064, USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
May 2008
©2005, 2008 Abbott Laboratories
1
NAME
ULTRA HDL
Reagent Handling
INTENDED USE
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
which could impact results.
The Ultra HDL (UHDL) assay is used for the quantitation of high density
lipoprotein (HDL) cholesterol in human serum or plasma.
Plasma lipoproteins are spherical particles containing varying amounts
of cholesterol, triglycerides, phospholipids, and proteins. Phospholipids,
free cholesterol, and proteins constitute the outer surface of the
lipoprotein particle, while the inner core contains mostly esterified
cholesterol and triglyceride. These particles serve to solubilize and
transport cholesterol and triglyceride in the bloodstream.
The relative proportions of protein and lipid determine the density
of these lipoproteins and provide a basis on which to begin their
classification.1 The classes are: chylomicron, very-low-density
lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density
lipoprotein (HDL). Numerous clinical studies have shown that the
different lipoprotein classes have very distinct and varied effects on
coronary heart disease risk.2
The principle role of HDL cholesterol in lipid metabolism is the uptake
and transport of cholesterol from peripheral tissues to the liver
through a process known as reverse cholesterol transport (a proposed
cardioprotective mechanism).3 Low HDL cholesterol levels are strongly
associated with an increased risk of coronary heart disease.4-7
Hence, the determination of serum HDL cholesterol is a useful tool in
identifying high-risk patients. The Adult Treatment Panel of the National
Cholesterol Education Program (NCEP) recommends that in all adults
20 years of age and over, a fasting lipoprotein profile (total cholesterol,
LDL cholesterol, HDL cholesterol, and triglyceride) should be obtained
once every five years to screen for coronary heart disease risk.8
Reagent Storage
• Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
• DO NOT FREEZE.
• Protect reagents from direct sunlight.
• Reagent stability is 28 days if the reagent is uncapped and onboard.
Indications of Deterioration
• Quality control results outside of the acceptance criteria defined by
your laboratory.
• Presence of turbidity.
1.
2.
3.
4.
It is recommended that all human sourced materials be considered
5.
and
contain a mixture of 5-chloro-2-methyl-4-isothiazolin3-one and 2-methyl-4-isothiazolin-3-one (3:1), which is a
component of ProClin, and are classified per applicable European
Community (EC) Directives as: Irritant (Xi). The following are the
appropriate Risk (R) and Safety (S) phrases:
R43
May cause sensitization by skin contact.
S24
Avoid contact with skin.
S35
This material and its container must be disposed
of in a safe way.
S37
Wear suitable gloves.
S46
If swallowed, seek medical advice immediately
and show this container or label.
The Ultra HDL assay is a homogeneous method for directly measuring
HDL cholesterol concentrations in serum or plasma without the need for
off-line pretreatment or centrifugation steps.
The method uses a two-reagent format and depends on the properties
of a unique detergent. This method is based on accelerating the
reaction of cholesterol oxidase (CO) with non-HDL unesterified
cholesterol and dissolving HDL cholesterol selectively using a specific
detergent. In the first reagent, non-HDL unesterified cholesterol is
subject to an enzyme reaction and the peroxide generated is consumed
by a peroxidase reaction with DSBmT yielding a colorless product. The
second reagent consists of a detergent (capable of solubilizing HDL
cholesterol), cholesterol esterase (CE), and chromagenic coupler to
develop color for the quantitative determination of HDL cholesterol.
Methodology: Accelerator Selective Detergent
Suitable Specimens
REAGENTS
Serum and plasma are acceptable specimens. The National Cholesterol
Education Program (NCEP) recommends using fasting specimens for
a lipoprotein profile. If the specimen is nonfasting, only the values for
total cholesterol and HDL cholesterol are usable.12
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
When processing samples, separate serum from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
into glass or plastic tubes. Acceptable anticoagulants are sodium
heparin, lithium heparin (with or without gel barrier), and spray-dried
EDTA.* Ensure centrifugation is adequate to remove platelets.
When processing samples, separate plasma from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
*NOTE: Lower HDL cholesterol results obtained from EDTA plasma
have been attributed to an osmotic dilution effect. The NCEP has
suggested multiplying EDTA plasma results by a factor of 1.03 to
correct the EDTA result to a serum equivalent value.13
ASSAY PARAMETERS section of this package insert and Section 5 of
Reagent Kit
3K33 Ultra HDL is supplied as a liquid, ready-to-use, two-reagent
kit which contains:
4 x 84 mL
4 x 32 mL
Estimated tests per kit: 1,440
Calculation is based on the minimum reagent fill volume per kit.
Cholesterol oxidase (E. coli)
Peroxidase (Horseradish)
Concentration
< 1,000 U/L
< 1,300 ppg U/L
N, N-bis (4-sulphobutyl)-m-toluidine-disodium
(DSBmT)
< 1.0 mmol/L
Accelerator
< 1.0 mmol/L
Ascorbic oxidase (Curcubita sp.)
< 3,000 U/L
Cholesterol esterase (Pseudomonas sp.)
< 1,500 U/L
4-Aminoantipyrine
< 0.1%
Detergent
< 2.0%
The Ultra HDL reagent is certified as traceable to the HDL cholesterol
designated comparison method, covering the NCEP medical decision
points, by the CDC-Certified Cholesterol Reference Method Laboratory
Network (CRMLN).
2
SPECIMEN COLLECTION AND HANDLING (Continued)
QUALITY CONTROL
Specimen Storage
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
Serum and Plasma
Temperature
Maximum
Storage
Bibliographic
Reference
20 to 25°C
2 days
14
2 to 8°C
7 days
14, 15
3 months
14
-20°C
al.14
Guder et
suggest storage of frozen specimens at -20°C for
no longer than the time interval cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
RESULTS
Refer to the instrument-specific operations manual for information on
results calculations.
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
PROCEDURE
Materials Provided
3K33 Ultra HDL Reagent Kit
Using three homogenous HDL assays, Camps, et al. have reported
artificially low HDL results in patients with liver cirrhosis.16 Published
studies are not available that define the severity of liver disease
necessary to affect lipoprotein and HDL metabolism, or establish other
possible patterns of interference with HDL results. When an HDL result
is diagnostically critical with concomitant clinically relevant liver disease,
use a recognized precipitation or ultracentrifugation HDL-reference
method for confirmation. Artificially decreased or increased HDL values
in the presence of dyslipidemias have been reported.17,18
For the AEROSET System only: Ultra HDL must be run on a separate
7D60-02 Total Bilirubin (TBil) and
7D74-20
line from
Triglyceride (Trig).
•
1E68 HDL Calibrator,
6 x 1 mL
• Control Material
Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and plasma: Specimens with HDL cholesterol values exceeding
180 mg/dL (4.66 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
EXPECTED VALUES
Reference Range
If using the Automated Dilution Protocol, the system performs a dilution
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information.
Serum/Plasma12
Manual dilutions should be performed as follows:
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
Range
(mg/dL)
Range
(mmol/L)
Major risk factor for heart disease
< 40
< 1.04
Negative risk factor for heart disease
≥ 60
≥ 1.55
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0259.
The National Cholesterol Education Program (NCEP) Adult Treatment
Panel III Report recommends the classification shown above.
Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
Linearity
Ultra HDL is linear up to 180 mg/dL (4.66 mmol/L), with recovery within
10% of the predicted value with 95% confidence.
Linearity was verified using a modified Clinical and Laboratory
Standards Institute (CLSI) protocol NCCLS EP6-A.19 An internal
verification study produced linear results up to 221 mg/dL
(5.72 mmol/L).
CALIBRATION
Calibration is stable for approximately 28 days (672 hours) and is
required with each change in reagent lot number. Verify calibration with
at least two levels of controls according to the established quality control
requirements for your laboratory. If control results fall outside acceptable
ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the HDL Calibrator
package insert.
Limit of Detection and Quantitation
The limit of quantitation (LOQ) for Ultra HDL is 5.0 mg/dL (0.13 mmol/L),
and the limit of detection (LOD) is 2.5 mg/dL (0.06 mmol/L).
The LOD testing for Ultra HDL was performed using a study design
based on CLSI protocol NCCLS EP17-A.20 An internal verification
study produced an LOD for Ultra HDL of 0.3 mg/dL (0.01 mmol/L).
The proportions of false positives (α) and false negatives (β) were less
than 5% and the limit of blank (LOB) was 0.2 mg/dL (0.01 mmol/L).
The LOQ is the analyte concentration at which the CV = 20%.
An internal verification study produced a CV of 9.1% at an HDL
cholesterol concentration of 4.4 mg/dL (0.11 mmol/L).
3
(Continued)
Accuracy
Accuracy data for Ultra HDL were collected using the HDL Cholesterol
Certification Protocol for Manufacturers.23 The data were analyzed
using CLSI protocol NCCLS EP21-A.24
Serum results from the Ultra HDL assay on an ARCHITECT c System
and an AEROSET System were compared with the designated
comparison method (DCM) for HDL cholesterol.
Interfering Substances
Interference studies were conducted using an acceptance criteria of
5% of the target value. Interference effects were assessed by Dose
Response method, at the medical decision levels of the analyte.
Lower Decision Level
Interfering
Substance
Ascorbic Acid
Interferent Concentration
N
ARCHITECT
Target Observed
AEROSET
Mean %Bias
-1.6
-1.8
%Total Error
10.9
10.2
2.9 mg/dL (165 μmol/L)
3
35
99
3
35
99
Method Comparison
Conjugated
Bilirubin
32.6 mg/dL (557 μmol/L)
3
34
104
63.3 mg/dL (1,082 μmol/L) 3
34
77
Unconjugated
Bilirubin
32.4 mg/dL (554 μmol/L)
3
33
105
65.5 mg/dL (1,120 μmol/L) 3
33
107
Correlation studies were performed using CLSI protocol NCCLS
EP9-A2.25
Serum results from the Ultra HDL assay on the AEROSET System
were compared with those from a commercially available accelerator
selective detergent methodology.
Serum results from the Ultra HDL assay on an ARCHITECT c System
were compared with those from the Ultra HDL assay on an AEROSET
System.
Hemoglobin
Intralipid
1,000 mg/dL (10 g/L)
3
31
102
2,000 mg/dL (20 g/L)
3
31
104
1,000 mg/dL (10 g/L)
3
32
102
2,000 mg/dL (20 g/L)
3
32
115
N
Upper Decision Level
AEROSET vs.
Comparative Method
111
ARCHITECT vs.
AEROSET
110
Y - Intercept
0.46
0.61
Target Observed
N
0.999
0.999
Slope
0.97
1.00
3
69
101
%Bias at 35 mg/dL
-2
1
3
69
101
%Bias at 60 mg/dL
-2
1
Conjugated
Bilirubin
32.0 mg/dL (547 μmol/L)
3
68
102
Range (mg/dL)
12 to 188
12 to 179
63.5 mg/dL (1,086 μmol/L) 3
68
95
Unconjugated
Bilirubin
33.9 mg/dL (580 μmol/L)
3
67
102
67.1 mg/dL (1,147 μmol/L) 3
67
102
Interfering
Substance
Ascorbic Acid
Hemoglobin
Intralipid
1,000 mg/dL (10 g/L)
3
62
99
2,000 mg/dL (20 g/L)
3
62
100
1,000 mg/dL (10 g/L)
3
75
99
2,000 mg/dL (20 g/L)
3
75
101
Ascorbic acid solutions at the above concentrations were prepared by
addition of L-ascorbic acid to human serum pools. Conjugated bilirubin
solutions at the above concentrations were prepared by addition of a
ditaurobilirubin stock to human serum pools. Unconjugated bilirubin
a NIST SRM 916a bilirubin stock to human serum pools. Hemoglobin
hemolysate to human serum pools. Intralipid solutions at the above
concentrations were prepared by addition of Intralipid to human serum
pools.
Interferences from medications or endogenous substances may affect
results.21
Precision
The imprecision of the Ultra HDL assay is total SD ≤ 1.7 mg/dL or
total CV ≤ 4%, whichever is greater. Internal verification studies were
performed using CLSI protocol NCCLS EP5-A.22 Representative data
are summarized below.
Control
Level 1
N
80
80
Mean (mg/dL)
20.9
78.9
0.76
Within Run
Between Run
Level 2
SD
0.36
%CV
1.7
1.0
SD
0.23
0.36
%CV
1.1
0.5
0.73
SD
1.07
%CV
5.1
0.9
SD
1.15
1.11
%CV
5.5
1.4
Between Day
Total
4
BIBLIOGRAPHY
TRADEMARKS
1. Gotto AM. Lipoprotein metabolism and the etiology of
hyperlipidemia. Hosp Pract 1988;23(Suppl 1):4–13.
2. Third Report of the National Cholesterol Education Program (NCEP)
Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults (Adult Treatment Panel III)—Final Report.
National Institutes of Health. National Heart, Lung, and Blood
Institute. NIH Publication No. 02-5215. September 2002; I-1–II-22.
3. Badimon JJ, Badimon L, Fuster V. Regression of atherosclerotic
lesions by high density lipoprotein plasma fraction in the
cholesterol-fed rabbit. J Clin Invest 1990;85(4):1234–41.
4. Castelli WP, Doyle JT, Gordon T, et al. HDL Cholesterol and
other lipids in coronary heart disease. The cooperative lipoprotein
phenotyping study. Circulation 1977;55(5):767–72.
5. Gordon T, Castelli WP, Hjortland MC, et al. High density lipoprotein
as a protective factor against coronary heart disease. Am J Med
1977;62(5):707.
6. Williams P, Robinson D, Bailey A. High density lipoprotein and
coronary risk factors in normal men. Lancet 1979;1(8107):72–5.
7. Kannel WB, Castelli WP, Gordon T. Cholesterol in the prediction
of atherosclerotic disease; New perspectives based on the
Framingham study. Ann Intern Med 1979;90(1):85–91.
Administration. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office; January 2007.
10. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization; 2004.
11. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline―Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
12. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
and treatment of high blood cholesterol in adults (Adult Treatment
Panel III). JAMA 2001;285(19):2486–97.
13. National Cholesterol Education Program. Recommendations on
Lipoprotein Measurement, from the Working Group on Lipoprotein
Measurement. National Institutes of Health. National Heart, Lung,
and Blood Institute. NIH Publication No. 95-3044. September 1995.
14. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:22–3.
15. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
16. Camps J, Simo JM, Guaita S, et al. Altered Composition of
Lipoproteins in Liver Cirrhosis Compromises Three Homogenous
Methods for HDL-Cholesterol. Clin Chem 1999;45(5):685–88.
17. Roberts WL, Leary ET, Lambert TL, et al. Falsely low direct
HDL-cholesterol results in a patient with dysbetalipoproteinemia.
Clin Chem 2000;46:560–2.
18. Lackner, KJ, Schmitz G. Beta-VLDL of patients with type III
hyperlipoproteinemia interferes with homogenous determination of
HDL-cholesterol based on polyethylene glycol-modified enzymes.
Clin Chem 1998;44:2546–8.
19. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity
of Quantitative Measurement Procedures: A Statistical Approach;
Approved Guideline (EP6-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2003.
20. Tholen DW, Linnet K, Kondratovich M, et al. Protocols for
Determination of Limits of Detection and Limits of Quantitation;
Approved Guideline (EP17-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2004.
21. Young DS, Effects of Drugs on Clinical Laboratory Tests, 5th ed.
Washington, DC: AACC Press, 2000:3-399–3-414.
22. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
23. Cholesterol Reference Method Laboratory Network. HDL Cholesterol
Certification Protocol for Manufacturers. November 2002. Accessed
July 11, 2005 from: http://www.cdc.gov/labstandards/pdf/crmln/
MFRHDLNov2002final.pdf.
24. Krouwer JS, Astles JR, Cooper WG, et al. Estimation of Total
Analytical Error for Clinical Laboratory Methods; Approved Guideline
25. Krouwer JS, Tholen DW, Garber CC, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline—Second
Edition (EP9-A2). Wayne, PA: The National Committee for Clinical
AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
c System is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.
Licensed under PCT/JP00/03860 and PCT/JP97/04442.
5
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Ultra HDL Serum/Plasma—Conventional and SI Units
Configure assay parameters — c 8000 SmartWash
● General
Assay:
UHDL
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
R1
TRIG0
10% Detergent B*** 345 1
Cuvette
Trig
10% Detergent B
345
о Interpretation
Assay: UHDL
Type: Photometric
Version: †
Number: 1093
● Reaction definition
о Reagent / Sample
о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 604 / 700
Main: 31 – 33
Last required read: 33
Absorbance range: ___ – ___
Color correction: ___ – ___
Sample blank type: Self
Blank: 14 – 16
● Reagent / Sample
Reagent: UHDL0
Diluent: Saline
Diluted
STANDARD : 2.0
___
_________ : ___
___
_________ : ___
___
Reaction check:
R1
200
___
Type 0
Water Dilution factor
___ =
1:1.00
___ =
___ =
о Reagent / Sample
Configure assay parameters — c 16000 SmartWash
Assay:
UHDL
COMPONENT REAGENT / ASSAY
WASH
Volume Replicates
R1
AlbG0
Detergent A
345
1
R1
AlbP0
Water
345
1
R1
TRIG0
10% Detergent B
345
1
Cuvette
Trig
10% Detergent B
345
о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
___
___
___
*** Select “Detergent B” for software prior to version 2.2.
R2
67
___
Type 0
Default
dilution
●
о
о
Ultra HDL Serum/Plasma—Conventional Units
Configure assay parameters — Results
о General
Assay: UHDL
Assay number: 1093
Dilution default range:
Result units: mg/dL
Low-Linearity:
5
High-Linearity: 180
Gender and age specific ranges:*
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
40 – 60
● Validity checks
None
Maximum absorbance variation: ___
о Calibration
о General
Assay:
● Calibration о SmartWash о Results
UHDL
● Calibrators
Calibrator set:
UHDL
Replicates: 3
о Volumes
о Validity checks
Calibrator level: Concentration:
Blank: Water
0‡
Cal 1: UHDL1
††
● Volumes
Calibrator level
Water
UHDL1
о Calibrators
о Volumes
Full interval: 672
Calibration type:
Adjust type: None
о Volumes
Span:
*
†
‡
††
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Intervals
о Intervals
Calibrator: UHDL
о Calibrators
Configure result units
[Range 1 – 3]
о Calibrators
Blank:
Cal 1:
о Interpretation
Calibration method: Linear
Sample
2.0
2.0
Diluted
sample
___
___
● Intervals
о Validity checks
Ultra HDL Serum/Plasma—SI Units
Diluent Water
___ ___
___ ___
о General
Assay: UHDL
Assay number: 1093
Result units: mmol/L
Low-Linearity:
0.13
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
1.04 – 1.55
о Validity checks
(hours)
о Intervals
_____ – _____
Blank – Blank
_____ – _____
0.00
0
UHDL
†
mg/dL
0
[Range 0 – 4]
1.0000
0.0000
о Calibration
● Validity checks
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
User defined.
Due to differences in instrument systems and unit configurations, version numbers may vary.
Displays the number of decimal places defined in the decimal places parameter field.
Refer to concentration specified on calibrator labeling.
6
UHDL
†
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
AEROSET SYSTEM ASSAY PARAMETERS
Ultra HDL Serum/Plasma—Conventional Units
Ultra HDL Serum/Plasma—SI Units
Assay Name
Assay #
UHDL
93
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
5
Reference Ranges*
Age
L-Reference-H
40
60
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Line
A-Line**
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
0.0
180
0.0
0.0
0.0
0.0
Max
0.0*
Assay Name
Assay #
UHDL
93
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.13
Reference Ranges*
Age
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
A-Line**
L-Reference-H
1.04
1.55
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
N/A
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
0.0
4.66
0.0
0.0
0.0
0.0
Max
0.0*
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Reaction Mode
AbsMaxVar
END UP
604 / 700
31 – 33 / 0 – 0
0.0
Sample Blank Test
Abs Limits
UHDL ( 93 )
14 – 16
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
2.0
0.0
0
0
Diluent: _______ – __*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
UHDL061 – ___*
200
0
0
Reagent 2
UHDL052 – ___*
67
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
0
mg/dL
Reaction Mode
AbsMaxVar
END UP
604 / 700
31 – 33 / 0 – 0
0.0
Sample Blank Test
Abs Limits
UHDL ( 93 )
14 – 16
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
2.0
0.0
0
0
Diluent: _______ – __*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
UHDL061 – ___*
200
0
0
Reagent 2
UHDL052 – ___*
67
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Calib Mode
Linear
3/3
Sample
S.Vol
BLK Water
2.0
C1
UHDL 1
2.0
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
Interval (H)
672
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0.0
FAC Limit (%)
10
Calib Mode
Linear
3/3
Sample
S.Vol
BLK Water
2.0
C1
UHDL 1
2.0
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
Interval (H)
672
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0.0
FAC Limit (%)
10
Rgt Probe
Rgt Probe
Reagent
ALBG061
ALBP061
Wash
AlkW
AlkW
Vol
345
345
Assay Name
—
Wash
—
Vol
—
Cuvette
Reagent
ALBG061
ALBP061
Wash
AlkW
AlkW
Vol
345
345
Assay Name
—
Wash
—
Vol
—
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
* User defined or instrument defined.
** Ultra HDL must be run on a separate line from
7D60-02 Total Bilirubin (TBil) and
7D74-20 Triglyceride (Trig).
7
6K2640-3.0/ 02
en
2010/04/28
6K26-40
CRP Vario
NOTE: This package insert must be read carefully prior to product use.
Package insert instructions must be followed accordingly. Reliability of assay
results cannot be guaranteed if there are any deviations from the instructions
in this package insert.
•
•
•
•
It is recommended that all human sourced materials be considered
• This product contains sodium azide; for a specific listing, refer to
the REAGENTS section of this package insert. Contact with acids
liberates very toxic gas. This material and its container must be
disposed of in a safe way.
NOTE: Refer to Section 8 of the instrument-specific operations
manual for proper handling and disposal of reagents containing
sodium azide.
For product not classified as dangerous per European Directive
1999/45/EC as amended – Safety data sheet available for professional
user on request.
INTENDED USE
The MULTIGENT CRP Vario assay [CRPVa] is intended for the quantitative
immunoturbidimetric determination of C-reactive protein in human serum
and plasma with variable assay ranges [CRP16, CRP32, CRP48] using the
ARCHITECT c Systems and the AEROSET System.
C-reactive protein (CRP) is an acute phase protein whose concentration
rises non-specifically in response to inflammation. CRP is seen to increase
as a result of the inflammatory process, most notably in response to
pneumococcal (bacterial) infection, histolytic disease, and a variety of other
disease states. Intraindividual variation is a major limitation of the assay
when the assay is used for directing therapies. Intraindividual variations of
the CRP levels are from 30% to 60%. Serial measurement may be required
to estimate true mean of CRP depending on the intended use in any specific
individual. CRP is used as a marker or general diagnostic indicator of
infections and inflammation, in addition to serving as a monitor of patient
response to pharmacological therapy and surgery.
Suitable Specimens
• Serum: Use serum collected by standard venipuncture techniques into
plastic tubes with or without gel. Ensure complete clot formation has
taken place prior to centrifugation. When processing samples, separate
serum from blood cells or gel according to the specimen collection tube
manufacturer’s instructions.
Some specimens, especially those from patients receiving anticoagulant or
thrombolytic therapy, may take longer to complete their clotting processes.
Fibrin clots may subsequently form in these sera and the clots could
cause erroneous test results.
into plastic tubes. Acceptable anticoagulants are lithium heparin (with or
without gel barrier), sodium heparin, and EDTA. Ensure centrifugation
is adequate to remove platelets. When processing samples, separate
plasma from blood cells or gel according to the specimen collection tube
manufacturer’s instructions.
NOTE: Glass tubes were not tested.
ASSAY PARAMETERS section of this package insert and Section 5 of the
CRP Vario is a latex immunoassay developed to accurately and reproducibly
measure blood CRP levels in serum and plasma. When an antigen-antibody
reaction occurs between CRP in a sample and anti-CRP antibody, which has
been adsorbed to latex particles, agglutination results. This agglutination is
detected as an absorbance change (572 nm), with the rate of change being
proportional to the quantity of CRP in the sample. Three different methods
(High Sensitivity [CRP16], Standard [CRP32], and Wide Range [CRP48]) are
available to cover a wide analytical measurement range.
Methodology: Turbidimetric/Immunoturbidimetric
REAGENTS
Reagent Kit
6K26-40 MULTIGENT CRP Vario is supplied as a two-reagent kit,
which contains:
3 x 90 mL
3 x 90 mL
Specimen Storage
Method
Estimated Tests per Kit*
High Sensitivity
2,192
Standard
2,192
Wide Range
1,843
*Calculation is based on the minimum reagent fill volume per kit.
Temperature
20 to 25°C
2 to 8°C
-20°C
Maximum
Storage
15 days
2 months
3 years
Bibliographic
Reference
5
5, 6
5
Concentration
Glycine buffer (pH 7.0)
1.28%
Rabbit anti-CRP polyclonal antibodies
0.2%
adsorbed on latex particles
Inactive Ingredients:
contains bovine albumin (≤ 1%) and sodium azide (< 0.1%).
contains bovine albumin (≤ 0.1%) and sodium azide (< 0.1%).
Guder et al.5 suggest storage of frozen specimens at -20°C for no longer
than the time interval cited above. However, limitations of laboratory
equipment make it necessary in practice for clinical laboratories to establish
a range around -20°C for specimen storage. This temperature range may be
established from either the freezer manufacturer’s specifications or your
laboratory standard operating procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present, mix
and centrifuge the specimen to remove particulates prior to testing.
PROCEDURE
Reagent Handling
Materials Provided
•
Ready for use.
•
Ready for use.
• Remove air bubbles, if present in the reagent cartridge, with a
new applicator stick. Alternatively, allow the reagent to sit at the
appropriate storage temperature to allow the bubbles to dissipate.
To minimize volume depletion, do not use a transfer pipette to remove
the bubbles.
that could impact results.
6K26-40 MULTIGENT CRP Vario Kit
•
6K26-13 MULTIGENT CRP Calibrator Set
7 x 2 mL
•
6K26-14 MULTIGENT CRP Calibrator HS
1 x 2 mL
•
6K26-15 MULTIGENT CRP Calibrator WR
1 x 2 mL
•
6K26-21 MULTIGENT CRP Control HS
3 x 2 mL
Assay Procedure
For a detailed description of how to run an assay on an ARCHITECT c System
or the AEROSET System, refer to Section 5 of the instrument-specific
operations manual.
Reagent Storage
• Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
• Reagent stability is 60 days if the reagent is uncapped and onboard.
Specimen Dilution Procedure
The ARCHITECT c Systems and the AEROSET System have automatic dilution
features; refer to Section 2 of the instrument-specific operations manual for
additional information.
Serum and Plasma: Specimens with CRP values exceeding the linearity are
flagged and may be diluted by following either the Automated Dilution Protocol
or the Manual Dilution Procedure.
Indications of Deterioration
Instability or deterioration should be suspected if there are visible signs of
leakage, extreme turbidity, microbial growth, if calibration does not meet the
appropriate package insert and/or instrument-specific operations manual
criteria, or if controls do not meet the appropriate criteria.
1/9
PROCEDURE (Continued)
EXPECTED VALUES
Specimen Dilution Procedure (Continued)
Reference Range
Range (mg/dL)
Range (mg/L)
≤ 0.5
≤5
Serum and plasma9
Schlebusch et al.10 have published pediatric reference ranges.
CRP is an acute phase protein whose concentration rises non-specifically
in response to inflammation. CRP values should not be interpreted without a
complete clinical evaluation. Follow-up testing of patients with elevated values
is recommended in order to help rule out a recent response to undetected
infection or tissue injury. It is recommended that each laboratory establish its
own expected range. For diagnostic purposes, the patient’s medical history
and all other clinical findings should be considered when evaluating CRP
results.
If using the Automated Dilution Protocol, the system performs a dilution of
the specimen and automatically corrects the concentration by multiplying the
result by the appropriate dilution factor. The dilution for each method is listed
below.
Method
Dilution
High Sensitivity
1:10
Standard
1:5
Wide Range
1:5
• The operator must enter the dilution factor in the patient or control order
screen. The system uses this dilution factor to automatically correct the
concentration by multiplying the result by the entered factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result.
NOTE: If a diluted sample result is flagged indicating it is less than the linear
low limit, do not report the result. Rerun using an appropriate dilution.
Reportable Range
The reportable range for MULTIGENT CRP Vario is:
High Sensitivity Method 0.01 to 16.00 mg/dL (0.1 to 160 mg/L}
Standard Method
0.02 to 32.00 mg/dL (0.2 to 320 mg/L)
Wide Range
0.02 to 48.00 mg/dL (0.2 to 480 mg/L)
All three methods were tested for prozone up to a CRP concentration of
100 mg/dL (1,000 mg/L). No prozone effect was observed within the linear
range of the assay. At 100 mg/dL (1,000 mg/L) the observed result was
correctly flagged as above the linearity of the assay.
CALIBRATION
NOTE: The MULTIGENT CRP Vario assay must be calibrated using the
individual levels listed in the instrument-specific assay parameters. Refer to
the parameters for the High Sensitivity [CRP16], Standard [CRP32], and Wide
Range [CPR48] methods and the CRP Calibrator package insert specific for
the method used in your laboratory.
Calibration is stable for approximately 15 days (360 hours) and is required
with each change in reagent lot number. Verify calibration curve with at
least two levels of controls according to the established quality control
requirements for your laboratory. If control results fall outside acceptable
ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to Section 6
of the instrument-specific operations manual.
Limit of Quantitation (LOQ)
The LOQ is the analyte concentration at which the CV = 20%. The limit of
quantification for MULTIGENT CRP Vario is:
High Sensitivity Method
0.01 mg/dL (0.1 mg/L)
Standard and Wide Range Methods 0.02 mg/dL (0.2 mg/L)
Interfering Substances
Interference studies were conducted using an acceptance criteria of ± 5%
deviation from the target value.
Interfering Substance
Bilirubin, conjugated and fetal
30 mg/dL (513 μmol/L)
Hemoglobin
500 mg/dL (5 g/L)
Intralipid
1,500 mg/dL (15 g/L)
Rheumatoid factor
550 IU/mL (550 kU/L)
Standardization
For information on calibrator standardization, refer to the CRP Calibrator
package insert specific for the method used in your laboratory.
Precision
QUALITY CONTROL
Precision was determined over five days with two runs and four replicates of
each control per day. Representative results in mg/L are summarized below.
CRP High Sensitivity Method
Control
Level 1
Level 2
Level 3
Level 4
N
40
40
40
40
Mean (mg/L)
0.6
5.0
14.9
53.0
SD
0.022
0.07
0.13
0.26
Within Run
%CV
3.62
1.32
0.86
0.50
SD
0.005
0.02
0.10
0.33
Between Run
%CV
0.85
0.38
0.64
0.62
SD
0.022
0.07
0.16
0.40
Total
%CV
3.72
1.46
1.04
0.76
As appropriate, refer to your laboratory standard operating procedure(s) and/
or quality assurance plan for additional quality control requirements and
potential corrective actions:
• Two levels of controls (normal and abnormal) are to be run every 24 hours.
• If quality control results do not meet the acceptance criteria defined by
your laboratory, patient values may be suspect. Follow the established
quality control procedures for your laboratory. Recalibration may be
necessary.
• Review quality control results and acceptance criteria following a change
of reagent or calibrator lot.
RESULTS
Refer to the instrument-specific operations manual for information on results
calculations.
To convert results from mg/dL to mg/L, multiply mg/dL by 10.7
Representative performance data are given in the EXPECTED VALUES and
SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package
insert. Results obtained in individual laboratories may vary.
The following are limitations on the use of the High Sensitivity CRP per
CDC/AHA recommendations.8
• Screening the entire adult population is not recommended.
• CRP is not a substitute for traditional cardiovascular risk factors.
• Acute coronary syndrome management should not depend on
CRP measurements.
• Patients with persistently unexplained CRP levels above 1.0 mg/dL
(10 mg/L) should be evaluated for noncardiovascular etiologies.
• Secondary prevention measures should not depend on CRP.
• Serial measurements of CRP should not be used to monitor treatment.
• The average of two CRP results, repeated optimally two weeks apart,
should be used on metabolically stable patients.
• In very rare cases gammopathy, particularly of the monoclonal IgM type
(e.g., Waldenström macroglobulinemia), may cause unreliable results.
6K2640-3.0/ 02
2/9
CRP Standard Method
Control
N
Mean (mg/L)
SD
Within Run
%CV
SD
Between Run
%CV
SD
Total
%CV
Level 1
40
5.0
0.06
1.11
0.04
0.80
0.07
1.41
Level 2
40
14.9
0.14
0.93
0.13
0.89
0.18
1.21
Level 3
40
53.8
0.50
0.92
0.47
0.87
0.64
1.19
CRP Wide Range Method
Control
N
Mean (mg/L)
SD
Within Run
%CV
SD
Between Run
%CV
SD
Total
%CV
Level 1
40
5.4
0.07
1.29
0.05
0.92
0.08
1.48
Level 2
40
18.3
0.17
0.93
0.13
0.71
0.22
1.18
Level 3
40
263.8
2.99
1.13
2.65
1.00
4.02
1.52
SPECIFIC PERFORMANCE CHARACTERISTICS (Continued)
TRADEMARKS
Method Comparison
CRP Vario is a trademark of Sentinel CH. SpA in various jurisdictions.
The ARCHITECT c System family of instruments consists of c 4000, c 8000, and
c 16000 Systems.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and MULTIGENT are
trademarks of Abbott Laboratories in various jurisdictions.
All other trademarks are property of their respective owners.
US Patent: 6,248,597 / 6,828,158 and equivalent patents in other countries.
Serum results from the MULTIGENT CRP Vario methods on the AEROSET
System were compared with the results from a commercially available
nephelometric methodology.
Serum results from the MULTIGENT CRP Vario methods on an ARCHITECT
c System were compared with the results on the AEROSET System.
For the MULTIGENT CRP High Sensitivity method only, serum results from an
ARCHITECT c System and the AEROSET System were also compared with
the results from a commercially available turbidimetric methodology.
Method comparison data are presented in mg/L.
N
Y - Intercept (95% CI*)
Slope (95% CI*)
Standard Error of the Estimate
Range (mg/L)
* CI = Confidence Interval
(continued)
N
Slope (95% CI*)
Range (mg/L)
CRP Standard Method
N
Slope (95% CI*)
Range (mg/L)
CRP Wide Range Method
N
Slope (95% CI*)
Range (mg/L)
AEROSET vs.
Nephelometer
45
-0.24 to 0.54
0.9994
0.985 to 1.006
0.96
1.0 to 104.0
ARCHITECT vs.
AEROSET
45
-0.33 to 0.45
0.9994
0.975 to 0.996
0.96
1.1 to 103.3
AEROSET vs.
Turbidimetric
Method
55
-0.01 to 0.07
0.9995
0.992 to 1.009
0.10
0.2 to 13.6
ARCHITECT vs.
Turbidimetric
Method
55
-0.02 to 0.10
0.9990
1.001 to 1.035
0.14
0.2 to 13.6
AEROSET vs.
Nephelometer
54
-0.68 to 0.50
0.9996
1.004 to 1.020
1.64
1.0 to 219.0
ARCHITECT vs.
AEROSET
54
-0.64 to 0.46
0.9997
0.977 to 0.991
1.58
0.6 to 223
AEROSET vs.
Nephelometer
59
-1.26 to 1.53
0.9989
1.023 to 1.051
4.10
1.0 to 286.0
ARCHITECT vs.
AEROSET
59
-1.44 to 2.04
0.9982
0.968 to 0.999
5.28
0.7 to 301.2
SYMBOLS IN PRODUCT LABELING
Calibrator
Contents of kit
Control
Reagent 1
Reagent 2
Serial number
Manufacturer
CONTACT INFORMATION
For product questions contact Abbott Laboratories Customer Support.
United States:
1-877-4ABBOTT
Canada:
International:
BIBLIOGRAPHY
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
US Department of Labor, Occupational Safety and Health Administration.
29 CFR Part 1910.1030. Bloodborne Pathogens.
US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington, DC: US
Government Printing Office, January 2007.
World Health Organization. Laboratory Biosafety Manual, 3rd ed. Geneva:
World Health Organization, 2004.
Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Workers
from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory
Standards Institute, 2005.
Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:24–5.
US Pharmacopeial Convention, Inc. General notices. In: US Pharmacopeia
National Formulary, 1995 ed (USP 23/NF 18). Rockville, MD: The US
Pharmacopeial Convention, Inc; 1994:11.
Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical
Chemistry and Molecular Diagnostics, 4th ed. St Louis, MO: Elsevier
Saunders; 2006:2263.
Pearson TA, Mensah GA, Alexander RW, et al. Markers of inflammation
and cardiovascular disease: application to clinical and public health
practice: A statement for healthcare professionals from the Centers for
Disease Control and Prevention and the American Heart Association.
Circulation 2003;107(3):499–511.
Dati F, Johnson AM, Whicher JT. The existing interim consensus
reference ranges and the future approach. Clin Chem Lab Med
2001;39(11):1134–6.
Schlebusch H, Liappis N, Kalina E, et al. High sensitive CRP and
creatinine: reference intervals from infancy to childhood. J Lab Med
2002;26(5/6):341–6.
SENTINEL CH. SpA
Via Robert Koch, 2
Milan 20152 Italy
3/9
Distributed by:
Abbott Laboratories Inc.
Abbott Park, IL 60064 USA
c Systems Assay Parameters
CRP Vario (High Sensitivity Method) Serum/Plasma:
Conventional and SI Units
● General
Assay: CRP16
Number: 2974
Reaction mode: Rate up
Type:
Reaction check:
о Validity checks
Read times
20 – 26
___ – ___
___ – ___
о Validity checks
Reagent volume:
Water volume:
Dispense mode:
R1
100
___
Type 0
Diluent Water Dilution factor
___
___ =
1:1.00
90
___ =
1:10.00
___
___ =
___
о Reagent / Sample
Assay:
CRP16
COMPONENT
REAGENT / ASSAY WASH
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Version: †
Primary
Secondary
572 / None
Main:
26
Flex:
0.7000 – 3.2000
Color correction:
None
Reagent: CRP0S
Diluent: Saline
Diluted
STANDARD : 4.0
___
DIL 1
: 10.0
4.0
________ : ___
___
Photometric
о Reagent / Sample
Wavelength:
Last required read:
Absorbance range:
Sample blank type:
о Interpretation
Conventional Units
R2
100
___
Type 0
Default
dilution
о General
о Calibration о SmartWash ● Results о Interpretation
Assay: CRP16
Assay number: 2974
Result units: mg/dL
Low-Linearity:
0.01
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 0.50
●
о
о
● Validity checks
None
Rate linearity %: ___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о General
Assay:
● Calibration
CRP16
● Calibrators
о SmartWash о Results
Calibration method: Spline
о Volumes
о Intervals
(Short name)‡‡
Calibrator level:
Blank: Water
(CRPHS)
Cal 1: 16CRP1
(CRP05)
Replicates: 2 [Range 1 - 3] Cal 2: 16CRP2
(CRP10)
Cal 3: 16CRP3
(CRP20)
Cal 4: 16CRP4
(CRP80)
Cal 5: 16CRP5
(CRP160)
Cal 6: 16CRP6
Calibrator set:
16CRP
о Calibrators
● Volumes
о Intervals
Calibrator: 16CRP
Blank:
Cal 1:
Cal 2:
Cal 3:
Cal 4:
Cal 5:
Cal 6:
Calibrator level
Water
16CRP1
16CRP2
16CRP3
16CRP4
16CRP5
16CRP6
Sample
4.0
4.0
4.0
4.0
4.0
4.0
4.0
Diluted
sample
___
___
___
___
___
___
___
о Calibrators
о Volumes
● Intervals
Full interval: 360 (hours)
Calibration type:
Adjust type: None
о Calibrators
о Volumes
Span:
о Intervals
-0.0500 – 0.0500
Blank – Blank
_____ – _____
0.00
0
о Interpretation
CRP16
†
mg/dL
2
[Range 0 – 4]
1.0000
0.0000
о Validity checks
Concentration:‡
(mg/dL)
(mg/L)
0.00
0.25
0.50
1.00
2.00
8.00
16.00
0.00
2.50
5.00
10.00
20.00
80.00
160.00
SI Units
о General
Assay: CRP16
Assay number: 2974
Result units: mg/L
Low-Linearity:
0.10
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 5.00
о Validity checks
Diluent
___
___
___
___
___
___
___
Water
___
___
___
___
___
___
___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Validity checks
CRP16
†
mg/L
2
[Range 0 – 4]
1.0000
0.0000
● Validity checks
† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡ Refer to the concentration specified on calibrator labeling. In ARCHITECT software version 5.00 and above, these values are defined on the
Configure calibrator set screen.
‡‡ Short name does not display on instrument screen.
* User defined.
6K2640-3.0/ 02
4/9
CRP Vario (Standard Method) Serum/Plasma:
● General
Assay: CRP32
Number: 2973
Type:
Reaction check:
о Validity checks
Read times
20 – 26
___ – ___
___ – ___
о Validity checks
Reagent volume:
Water volume:
Dispense mode:
R1
100
___
Type 0
___
___ =
1:1.00
80
___ =
1:5.00
___
___ =
___
о Reagent / Sample
Assay:
CRP32
COMPONENT
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Version: †
Primary
Secondary
572 / None
Main:
26
Flex:
0.7000 – 3.2000
Color correction:
None
Reagent: CRP0S
Diluent: Saline
Diluted
STANDARD : 2.0
___
DIL 1
: 20.0
2.0
________ : ___
___
Photometric
о Reagent / Sample
Wavelength:
Last required read:
Absorbance range:
Sample blank type:
о Interpretation
Conventional Units
R2
100
___
Type 0
Default
dilution
о General
Assay: CRP32
Assay number: 2973
Result units: mg/dL
Low-Linearity:
0.02
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 0.50
●
о
о
● Validity checks
None
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о General
Assay:
● Calibration
CRP32
● Calibrators
о Volumes
о Intervals
(Short name)‡‡
Calibrator level:
Blank: Water
(CRP05)
Cal 1: 32CRP1
(CRP10)
(CRP20)
Cal 3: 32CRP3
(CRP40)
Cal 4: 32CRP4
(CRP160)
Cal 5: 32CRP5
(CRP320)
Cal 6: 32CRP6
Calibrator set:
32CRP
о Calibrators
● Volumes
о Intervals
Calibrator: 32CRP
Blank:
Cal 1:
Cal 2:
Cal 3:
Cal 4:
Cal 5:
Cal 6:
Calibrator level
Water
32CRP1
32CRP2
32CRP3
32CRP4
32CRP5
32CRP6
Sample
2.0
2.0
2.0
2.0
2.0
2.0
2.0
Diluted
sample
___
___
___
___
___
___
___
о Calibrators
о Volumes
● Intervals
Calibration type:
Adjust type: None
о Calibrators
о Volumes
Span:
о Intervals
-0.0500 – 0.0500
Blank – Blank
_____ – _____
0.00
0
о Interpretation
CRP32
†
mg/dL
2
[Range 0 – 4]
1.0000
0.0000
о Validity checks
Concentration:‡
(mg/dL)
(mg/L)
0.00
0.50
1.00
2.00
4.00
16.00
32.00
0.0
5.0
10.0
20.0
40.0
160.0
320.0
SI Units
о General
Assay: CRP32
Assay number: 2973
Result units: mg/L
Low-Linearity:
0.2
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.0 – 5.0
о Validity checks
Diluent
___
___
___
___
___
___
___
Water
___
___
___
___
___
___
___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Validity checks
CRP32
†
mg/L
1
[Range 0 – 4]
1.0000
0.0000
● Validity checks
* User defined.
5/9
6K2640-3.0/ 02
CRP Vario (Wide Range Method) Serum/Plasma:
● General
Assay: CRP48
Number: 2975
Type:
Reaction check:
о Validity checks
Read times
20 – 26
___ – ___
___ – ___
о Validity checks
Reagent volume:
Water volume:
Dispense mode:
R1
120
___
Type 0
___
___ =
1:1.00
80
___ =
1:5.00
___
___ =
___
о Reagent / Sample
Assay:
CRP48
COMPONENT
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Version: †
Primary
Secondary
572 / None
Main:
26
Flex:
0.7000 – 3.2000
Color correction:
None
Reagent: CRP0S
Diluent: Saline
Diluted
STANDARD : 2.0
___
DIL 1
: 20.0
2.0
________ : ___
___
Photometric
о Reagent / Sample
Wavelength:
Last required read:
Absorbance range:
Sample blank type:
о Interpretation
Conventional Units
R2
120
___
Type 0
Default
dilution
о General
Assay: CRP48
Assay number: 2975
Result units: mg/dL
Low-Linearity:
0.02
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 0.50
●
о
о
● Validity checks
None
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о General
Assay:
● Calibration
CRP48
● Calibrators
о Volumes
о Intervals
(Short name)‡‡
Calibrator level:
Blank: Water
(CRP05)
Cal 1: 48CRP1
(CRP10)
(CRP20)
Cal 3: 48CRP3
(CRP40)
Cal 4: 48CRP4
(CRP160)
Cal 5: 48CRP5
(CRPWR)
Cal 6: 48CRP6
Calibrator set:
48CRP
о Calibrators
● Volumes
о Intervals
Calibrator: 48CRP
Blank:
Cal 1:
Cal 2:
Cal 3:
Cal 4:
Cal 5:
Cal 6:
Calibrator level
Water
48CRP1
48CRP2
48CRP3
48CRP4
48CRP5
48CRP6
Sample
2.0
2.0
4.0
5.0
5.0
3.0
2.0
Diluted
sample
___
___
___
___
___
___
___
о Calibrators
о Volumes
● Intervals
Calibration type:
Adjust type: None
о Calibrators
о Volumes
Span:
о Intervals
-0.0500 – 0.0500
Blank – Blank
_____ – _____
0.00
0
о Interpretation
CRP48
†
mg/dL
2
[Range 0 – 4]
1.0000
0.0000
о Validity checks
Concentration:‡
(mg/dL)
(mg/L)
0.00
0.50
1.00
2.00
4.00
16.00
48.00
0.0
5.0
10.0
20.0
40.0
160.0
480.0
SI Units
о General
Assay: CRP48
Assay number: 2975
Result units: mg/L
Low-Linearity:
0.2
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.0 – 5.0
о Validity checks
Diluent
___
___
___
___
___
___
___
Water
___
___
___
___
___
___
___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Validity checks
CRP48
†
mg/L
1
[Range 0 – 4]
1.0000
0.0000
● Validity checks
* User defined.
6K2640-3.0/ 02
6/9
Conventional Units
SI Units
Assay Name
Assay #
CRP16
974
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.01
Reference Ranges*
Age
L-Reference-H
0.00
0.50
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Line
*
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
16.00
0.0
0.0
0.0
0.0
Assay Name
Assay #
CRP16
974
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.10
Reference Ranges*
Age
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
*
L-Reference-H
0.00
5.00
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
N/A
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
160.00
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
4.0
0.0
0
0
Rgt Name/Pos
Dil 1
10.0
4.0
90
0
Diluent: _____ _–__*
Dil 2
4.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
100
0
0
Reagent 2
CRP0S62 – ___*
100
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mg/dL
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
4.0
0.0
0
0
Rgt Name/Pos
Dil 1
10.0
4.0
90
0
Diluent: _____ _–__*
Dil 2
4.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
100
0
0
Reagent 2
CRP0S62 – ___*
100
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mg/L
Calib Mode
Spline
2/2
Sample
Conc
BLK Water
0
C1 CRPHS
0.25
C2 CRP05
0.5
C3 CRP10
1.0
C4 CRP20
2.0
C5 CRP40
4.0
C6 CRP80
8.0
C7 CRP160
16.0
S.Vol
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
Interval (H)
360
Extrapolation % Span
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
0.0
0
0
Calib Mode
Spline
2/2
Sample
Conc
BLK Water
0
C1 CRPHS
2.5
C2 CRP05
5
C3 CRP10
10
C4 CRP20
20
C5 CRP40
40
C6 CRP80
80
C7 CRP160
160
S.Vol
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
Interval (H)
360
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
0.0
0
0
Rgt Probe
Rgt Probe
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
* User or instrument defined.
7/9
6K2640-3.0/ 02
Conventional Units
SI Units
Assay Name
Assay #
CRP32
973
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.02
Reference Ranges*
Age
L-Reference-H
0.00
0.50
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Line
*
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
32.00
0.0
0.0
0.0
0.0
Assay Name
Assay #
CRP32
973
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.2
Reference Ranges*
Age
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
L-Reference-H
0.0
5.0
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
N/A
Line
*
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
320.0
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
20.0
2.0
80
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
100
0
0
Reagent 2
CRP0S62 – ___*
100
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mg/dL
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
20.0
2.0
80
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
100
0
0
Reagent 2
CRP0S62 – ___*
100
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
1
mg/L
Calib Mode
Spline
2/2
Sample
Conc
BLK Water
0
C1 CRP05
0.5
C2 CRP10
1.0
C3 CRP20
2.0
C4 CRP40
4.0
C5 CRP80
8.0
C6 CRP160
16.0
C7 CRP320
32.0
S.Vol
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
Interval (H)
360
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
0.0
0
0
Calib Mode
Spline
2/2
Sample
Conc
BLK Water
0
C1 CRP05
5
C2 CRP10
10
C3 CRP20
20
C4 CRP40
40
C5 CRP80
80
C6 CRP160
160
C7 CRP320
320
S.Vol
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
Interval (H)
360
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
0.0
0
0
Rgt Probe
Rgt Probe
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
6K2640-3.0/ 02
8/9
CRP Vario (Wide Range Method) Serum/Plasma—
Conventional Units
CRP Vario (Wide Range Method) Serum/Plasma—SI Units
Assay Name
Assay #
CRP48
975
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.02
Reference Ranges*
Age
L-Reference-H
0.00
0.50
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Line
*
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
48.00
0.0
0.0
0.0
0.0
Assay Name
Assay #
CRP48
975
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.2
Reference Ranges*
Age
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
*
L-Reference-H
0.0
5.0
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
N/A
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
480.0
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
20.0
2.0
80
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
120
0
0
Reagent 2
CRP0S62 – ___*
120
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mg/dL
Reaction Mode
Linearity%
RATE UP
572 / –
20 – 26 / 0 – 0
0
Sample Blank Test
Abs Limits
_____ ( ___ )
0–0
0–0
0.7 – 3.2
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
20.0
2.0
80
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
CRP0S61 – ___*
120
0
0
Reagent 2
CRP0S62 – ___*
120
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
1
mg/L
Calib Mode
Spline
2/2
Sample
Conc**
BLK Water
0
C1 CRP05
0.5
C2 CRP10
2.0
C3 CRP20
5.0
C4 CRP40
10.0
C5 CRP160
24.0
C6 CRPWR
48.0
S.Vol
2.0
2.0
4.0
5.0
5.0
3.0
2.0
Interval (H)
360
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
Calib Mode
Spline
2/2
Sample
Conc**
BLK Water
0
C1 CRP05
5
C2 CRP10
20
C3 CRP20
50
C4 CRP40
100
C5 CRP160
240
C6 CRPWR
480
S.Vol
2.0
2.0
4.0
5.0
5.0
3.0
2.0
Interval (H)
360
Span Abs Range
0
BLK – 1
0.0 – 0.0
DS.Vol D.Vol
W.Vol
Blk Abs Range
0.0
0
0
-0.05 – 0.05
0.0
0
0
Cal Deviation
0.0
0
0
0.01
0.0
0
0
FAC Limit (%)
0.0
0
0
10
0.0
0
0
0.0
0
0
Rgt Probe
Rgt Probe
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
** The calibrator concentrations in this column must be used for this method to correctly calculate the calibration curve.
NOTE: Do not use the concentrations listed on the calibrator vial labels for this method.
9/9
6K2640-3.0/ 02
en
TSH
system
7K62
49-3481/R3
B7K620
Read Highlighted Changes
Revised June, 2010
TSH
Customer Service: Contact your local representative or find country specific contact information
on www.abbottdiagnostics.com.
Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any
deviations from the instructions in this package insert.
Key to symbols used
List Number
Reagent Lot
In Vitro Diagnostic Medical
Device
Calibrator (1, 2)
Serial Number
Control Low, Medium,
High (L, M, H)
Lot Number
Assay CD-ROM
Expiration Date
Reaction Vessels
Sample Cups
Store at 2-8°C
Septum
Replacement Caps
Warning: Severe Irritant
Manufacturer
See REAGENTS section for a full explanation of symbols used in reagent
component naming.
1
NAME
In the first step, sample, anti-β TSH antibody coated paramagnetic
microparticles and TSH Assay Diluent are combined. TSH present in
the sample binds to the anti-TSH antibody coated microparticles. After
washing, anti-α TSH acridinium labeled conjugate is added in the second
step. Pre-Trigger and Trigger Solutions are then added to the reaction
mixture; the resulting chemiluminescent reaction is measured as relative
light units (RLUs). A direct relationship exists between the amount of
TSH in the sample and the RLUs detected by the ARCHITECT i optical
system.
For additional information on system and assay technology, refer to the
ARCHITECT System Operations Manual, Section 3.
ARCHITECT TSH
INTENDED USE
The ARCHITECT TSH assay is a Chemiluminescent Microparticle
Immunoassay (CMIA) for the quantitative determination of human thyroid
stimulating hormone (TSH) in human serum and plasma.
Human Thyroid Stimulating Hormone (TSH) or thyrotropin is a glycoprotein
with a molecular weight of approximately 28,000 daltons, synthesized
by the basophilic cells (thyrotropes) of the anterior pituitary.1 TSH is
composed of two non-covalently linked subunits designated alpha and
beta. Although the alpha subunit of TSH is common to the luteinizing
hormone (LH), follicle stimulating hormone (FSH) and human chorionic
gonadotropin (hCG), the beta subunits of these glycoproteins are hormone
specific and confer biological as well as immunological specificity.
Both alpha and beta subunits are required for biological activity.1 TSH
stimulates the production and secretion of the metabolically active thyroid
hormones, thyroxine (T4) and triiodothyronine (T3), by interacting with a
specific receptor on the thyroid cell surface.2 T3 and T4 are responsible
for regulating diverse biochemical processes throughout the body which
are essential for normal development and metabolic and neural activity.
The synthesis and secretion of TSH is stimulated by thyrotropin releasing
hormone (TRH), the hypothalamic tripeptide, in response to low levels of
circulating thyroid hormones.3,4 Elevated levels of T3 and T4 suppress
the production of TSH via a classic negative feedback mechanism. Other
evidence also indicates that somatostatin and dopamine exert inhibitory
control over TSH release, suggesting that the hypothalamus may provide
both inhibitory and stimulatory influence on pituitary TSH production.5
Failure at any level of regulation of the hypothalamic-pituitary-thyroid axis
will result in either underproduction (hypothyroidism) or overproduction
(hyperthyroidism) of T4 and/or T3.
In cases of primary hypothyroidism, T3 and T4 levels are low and TSH
levels are significantly elevated.6 In the case of pituitary dysfunction,
either due to intrinsic hypothalamic or pituitary disease; i.e., central
hypothyroidism, normal or marginally elevated basal TSH levels are
often seen despite significant reduction in T4 and/or T3 levels. These
inappropriate TSH values are due to a reduction in TSH bioactivity which
is frequently observed in such cases. Routine TRH stimulation is advised
to confirm the diagnosis in such cases. Secondary hypothyroidism
typically results in an impaired TSH response to TRH, while in tertiary
hypothyroidism the TSH response to TRH may be normal, prolonged or
exaggerated.7-9
Primary hyperthyroidism (e.g., Grave’s Disease, nodular goiter) is
associated with high levels of thyroid hormones and depressed or
undetectable levels of TSH.10 The TRH stimulation test has been used
in diagnosis of hyperthyroidism. Hyperthyroid patients show a subnormal
response to the TRH test.11 In addition, large doses of glucocorticoids,
somatostatin, dopamine and replacement doses of thyroid hormones
reduce or totally blunt the TSH response to TRH.11,12
Earlier assays for serum TSH lacked the sensitivity to be used as a
primary test of thyroid function.13 Sensitive TSH assays now available,
with increased ability to clearly distinguish between euthyroid and
hyperthyroid populations, are changing thyroid function testing. Analytical
sensitivity, as a means of assessing low concentration accuracy, is being
replaced by functional sensitivity.14 The American Thyroid Association
has formally recommended the use of functional sensitivity as the means
to quantify the sensitivity of TSH assays,15 although analytical sensitivity
is still widely used. Third generation TSH assays exhibit 20% interassay
CVs at < 0.02 μIU/mL and are useful in the discrimination of patients with
true hyperthyroidism from those with TSH suppression seen in subclinical
hyperthyroidism and some non-thyroidal illnesses.16 Other thyroid tests
(Free T4 estimate, Total T4, T-Uptake, and Total T3) combined with the
ability to accurately measure low levels of TSH, improve the efficiency
of thyroid diagnosis.17
The ARCHITECT TSH assay is used as an aid in the assessment of thyroid
status, diagnosis of thyroid disease, and treatment of thyroid disease.
REAGENTS
Reagent Kit, 100 Tests/500 Tests
NOTE: Some kit sizes are not available in all countries or for use on all
ARCHITECT i Systems. Please contact your local distributor.
ARCHITECT TSH Reagent Kit (7K62)
•
1 or 4 Bottle(s) (6.6 mL/27.0 mL) Anti-β TSH
(mouse, monoclonal) coated Microparticles in TRIS buffer with
protein (bovine) stabilizers. Preservative: antimicrobial agents.
•
1 or 4 Bottle(s) (5.9 mL/26.3 mL) Anti-α TSH (mouse,
monoclonal) acridinium-labeled Conjugate in MES buffer with protein
(bovine) stabilizers. Minimum concentration: 60 ng/mL. Preservative:
antimicrobial agent.
•
1 or 4 Bottle(s) (8.0 mL/40.7 mL) TSH Assay
Diluent in TRIS buffer. Preservative: antimicrobial agents.
Manual Diluent
ARCHITECT i Multi-Assay Manual Diluent (7D82-50)
•
1 Bottle (100 mL) ARCHITECT
i Multi-Assay Manual Diluent containing phosphate buffered saline
solution. Preservative: antimicrobial agent.
Other Reagents
ARCHITECT i Pre-Trigger Solution
•
Pre-Trigger Solution containing 1.32%
(w/v) hydrogen peroxide.
ARCHITECT i Trigger Solution
•
Trigger Solution containing 0.35N sodium
hydroxide.
ARCHITECT i Wash Buffer
NOTE: Bottle and volume varies based on order.
•
Wash Buffer containing phosphate buffered saline
solution. Preservatives: antimicrobial agents.
•
• For In Vitro Diagnostic Use
• Package insert instructions must be carefully followed. Reliability of
assay results cannot be guaranteed if there are any deviations from
the instructions in this package insert.
Safety Precautions
• CAUTION: This product may require the handling of human
specimens. It is recommended that all human sourced materials be
considered potentially infectious and handled in accordance with
the OSHA Standard on Bloodborne Pathogens18. Biosafety Level
219 or other appropriate biosafety practices20,21 should be used
for materials that contain or are suspected of containing infectious
agents.
The following warnings and precautions apply to this component:
• Assay Diluent
WARNING:
H315
H319
H335
Prevention
P264
P280
BIOLOGICAL PRINCIPLES OF THE PROCEDURE
The ARCHITECT TSH assay is a two-step immunoassay to determine
the presence of thyroid stimulating hormone (TSH) in human serum and
plasma using Chemiluminescent Microparticle Immunoassay (CMIA)
technology with flexible assay protocols, referred to as Chemiflex.
P261
P271
2
Contains Tris Hydroxymethyl
Aminomethane and Tromethamine
Hydrochloride.
Causes skin irritation.
Causes serious eye irritation.
May cause respiratory irritation.
Wash hands thoroughly after handling
Wear protective gloves / protective
clothing / eye protection.
Avoid breathing mist / vapours / spray.
Use only outdoors or in a wellventilated area.
Response
P305+P351
+ P338
P337+P313
P302+P352
P332+P313
P362
P304+340
P312
Indications of Reagent Deterioration
When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test
results may be invalid and may require retesting. Assay recalibration may
be necessary. For troubleshooting information, refer to the ARCHITECT
System Operations Manual, Section 10.
IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact
lenses, if present and easy to do.
Continue rinsing.
If eye irritation persists: Get medical
advice / attention.
IF ON SKIN: Wash with plenty of soap
and water.
If skin irritation occurs: Get medical
advice / attention.
Take off contaminated clothing and
wash before reuse.
IF INHALED: Remove victim to fresh
air and keep at rest in a position
comfortable for breathing.
Call a POISON CENTER or doctor/
physician if you feel unwell.
INSTRUMENT PROCEDURE
• The ARCHITECT TSH assay file must be installed on the ARCHITECT
i System from the ARCHITECT i Assay CD-ROM prior to performing
the assay. For detailed instructions on assay file installation, refer to
the ARCHITECT System Operations Manual, Section 2.
• For a detailed description of system procedures, refer to the
ARCHITECT System Operations Manual.
• The default result unit for the ARCHITECT TSH assay is μIU/ mL. An
alternate result unit, mIU/L, may be selected for reporting results by
editing assay parameter “Result concentration units”, to mIU/L. The
conversion factor used by the system is 1.
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
• Human serum (including serum collected in serum separator tubes)
or plasma collected in lithium heparin, sodium heparin, or potassium
EDTA anticoagulant tubes may be used in the ARCHITECT TSH
assay. Other anticoagulants have not been validated for use with the
ARCHITECT TSH assay.
• Follow these package insert instructions as well as the specimen
collection tube manufacturer’s instructions for specimen
collection and preparation for analysis. Refer to the specimen
collection tube manufacturer’s instructions for centrifugation
time and speed.
• Insufficient processing of sample, or disruption of the sample
during transportation may cause depressed results.
• For optimal results, serum and plasma specimens should be free
of fibrin, red blood cells, or other particulate matter. Centrifuge
specimens containing fibrin, red blood cells, or particulate matter
prior to use to ensure consistency in the results.
• Ensure that complete clot formation in serum specimens has taken
place prior to centrifugation. Some specimens, especially those
from patients receiving anticoagulant or thrombolytic therapy
may exhibit increased clotting time. If specimens are centrifuged
before a complete clot forms, the presence of fibrin or particulate
matter may cause erroneous results. Centrifuge specimens
containing fibrin, red blood cells, or particulate matter. Note that
interfering levels of fibrin may be present in samples that do not
have obvious or visible particulate matter.
• If proper specimen collection and preparation cannot be verified,
or if samples have been disrupted due to transportation or sample
handling, an additional centrifugation step is recommended.
Centrifugation conditions should be sufficient to remove
particulate matter. Aliquots poured versus pipetted from specimen
tube types that do not include serum separators are at higher risk
of including particulates and generating depressed results.
• Failure to follow these instructions may result in depressed
specimen results.
• If testing will be delayed more than 24 hours, remove serum or
plasma from the clot, serum separator or red blood cells. Specimens
may be stored for up to 7 days at 2-8°C prior to being tested. If testing
will be delayed more than 7 days, specimens should be frozen at
-10°C or colder. Specimens stored frozen at -10°C or colder for 6
months showed no performance difference.
• The ARCHITECT i System does not provide the capability to verify
specimen type. It is the responsibility of the operator to verify the
correct specimen types are used in the ARCHITECT TSH assay.
• Use caution when handling patient specimens to prevent cross
contamination. Use of disposable pipettes or pipette tips is
recommended.
• For optimal results, inspect all samples for bubbles. Remove bubbles
with an applicator stick prior to analysis. Use a new applicator stick
for each sample to prevent cross contamination.
Storage
P403 + P233 Store in a well-ventilated place. Keep
container tightly closed.
P405
Store locked up.
This material and its container must be disposed of in a safe way.
• For a detailed discussion of safety precautions during system
operation, refer to the ARCHITECT System Operations Manual,
Section 8.
Handling Precautions
• Do not use reagent kits beyond the expiration date.
• Do not mix reagents from different reagent kits.
• Prior to loading the ARCHITECT TSH Reagent Kit on the system for
the first time, the microparticle bottle requires mixing to resuspend
microparticles that have settled during shipment. For microparticle
mixing instructions, refer to the PROCEDURE, Assay Procedure
section of this package insert.
• Septums MUST be used to prevent reagent evaporation and
contamination and to ensure reagent integrity. Reliability of assay
results cannot be guaranteed if septums are not used according to
• To avoid contamination, wear clean gloves when placing a septum
on an uncapped reagent bottle.
• Once a septum has been placed on an open reagent bottle, do
not invert the bottle as this will result in reagent leakage and may
compromise assay results.
• Over time, residual liquids may dry on the septum surface. These are
typically dried salts which have no effect on assay efficacy.
• For a detailed discussion of handling precautions during system
Section 7.
Storage Instructions
•
The ARCHITECT TSH Reagent Kit must be stored at 2-8°C
and may be used immediately after removal from 2-8°C storage.
• When stored and handled as directed, reagents are stable until the
expiration date.
• The ARCHITECT TSH Reagent Kit may be stored on-board the
ARCHITECT i System for a maximum of 30 days. After 30 days,
the reagent kit must be discarded. For information on tracking
on‑board time, refer to the ARCHITECT System Operations Manual,
Section 5.
• Reagents may be stored on or off the ARCHITECT i System. If
reagents are removed from the system, store them at 2-8°C (with
septums and replacement caps) in an upright position. For reagents
stored off the system, it is recommended that they be stored
in their original trays and boxes to ensure they remain upright. If
the microparticle bottle does not remain upright (with a septum
installed) while in refrigerated storage off the system, the reagent
kit must be discarded. After reagents are removed from the system,
you must initiate a scan to update the on-board stability timer.
3
• Multiple freeze-thaw cycles of specimens should be avoided.
Specimens must be mixed THOROUGHLY after thawing, by LOW
speed vortexing or by gently inverting, and centrifuged prior to use to
remove red blood cells or particulate matter to ensure consistency
in the results.
• When shipped, specimens must be packaged and labeled in
compliance with applicable state, federal and international regulations
covering the transport of clinical specimens and infectious substances.
Specimens may be shipped ambient or under thermally controlled
refrigerated conditions. Prior to shipment, it is recommended that
specimens be removed from the clot, serum separator or red blood
cells.
• Load samples
• For information on loading samples, refer to the ARCHITECT
System Operations Manual, Section 5
• Press RUN. The ARCHITECT i System performs the following
function:
• Moves the sample to the aspiration point
• Loads a reaction vessel (RV) into the process path
• Aspirates and transfers sample into the RV
• Advances the RV one position and transfers microparticles and
diluent into the RV
• Mixes, incubates and washes the reaction mixture
• Adds conjugate to the RV
• Mixes, incubates and washes the reaction mixture
• Adds Pre-Trigger and Trigger Solutions
• Measures chemiluminescent emission to determine the quantity
of TSH in the sample
• Aspirates contents of RV to liquid waste and unloads RV to solid
waste
• Calculates the result
• For information on ordering patient specimens, calibrators and
controls, and general operating procedures refer to the ARCHITECT
• For optimal performance, it is important to follow the routine
maintenance procedures defined in the ARCHITECT System
Operations Manual, Section 9. If your laboratory requires more
frequent maintenance, follow those procedures.
PROCEDURE
Materials Provided
• 7K62 ARCHITECT TSH Reagent Kit
•
•
•
•
•
•
•
•
•
•
•
•
•
ARCHITECT i System
ARCHITECT i
7K62-01 ARCHITECT TSH Calibrators
7K62-10 ARCHITECT TSH Controls
7D82-50 ARCHITECT i Multi-Assay Manual Diluent
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
For information on materials required for maintenance procedures,
refer to the ARCHITECT System Operations Manual, Section 9.
• Pipettes or pipette tips (optional) to deliver the volumes specified on
the patient or control order screen.
Specimens with a TSH value exceeding 100.0000 μIU/mL, are flagged
with the code “>100.0000” and may be diluted with either the Automated
Dilution Protocol or the Manual Dilution Procedure.
• If using the Automated Dilution Protocol, the system performs
a 1:5 dilution of the specimen and automatically calculates the
concentration of the diluted specimen and reports the result.
• Manual dilutions should be performed as follows:
• The suggested dilution for TSH is 1:10. It is recommended
dilutions not exceed 1:10.
• For example, to perform a 1:10 dilution, add 30 μL of the patient
specimen to 270 μL of ARCHITECT i Multi-Assay Manual Diluent
(7D82-50).
• The operator must enter the dilution factor in the patient or
control order screen. The system will use this dilution factor to
automatically calculate the concentration of the sample before
dilution. This will be the reported result. The result (before dilution
factor is applied) should be greater than 0.0100 μIU/mL.
• If the operator does not enter the dilution factor, the reported
result will be that of the diluted sample. This result (before dilution
factor is applied) should be greater than 0.0100 μIU/mL.
• For detailed information on ordering dilutions, refer to the ARCHITECT
Assay Procedure
• Before loading the ARCHITECT TSH Reagent Kit on the system for
the first time, the microparticle bottle requires mixing to resuspend
microparticles that have settled during shipment:
• Invert the microparticle bottle 30 times.
• Visually inspect the bottle to ensure microparticles are
resuspended. If microparticles are still adhered to the bottle,
continue to invert the bottle until the microparticles have been
completely resuspended.
• Once the microparticles have been resuspended, remove and
discard the cap. Wearing clean gloves, remove a septum from
the bag. Carefully snap the septum onto the top of the bottle.
• If the microparticles do not resuspend, Do Not Use. Contact
your local Abbott representative.
• Order tests.
• Load the ARCHITECT TSH Reagent Kit on the ARCHITECT i System.
Verify that all necessary assay reagents are present. Ensure that
septums are present on all reagent bottles.
• The minimum sample cup volume is calculated by the system and
is printed on the Orderlist report. No more than 9 replicates may
be sampled from the same sample cup. To minimize the effects of
evaporation verify adequate sample cup volume is present prior to
running the test.
• Priority: 200 μL for the first TSH test plus 150 μL for each
additional TSH test from the same sample cup
• ≤ 3 hours onboard: 200 μL for the first TSH test plus 150 μL for
each additional TSH test from the same sample cup
• > 3 hours onboard: additional sample volume is required. Refer
to the ARCHITECT System Operations Manual, Section 5 for
information on sample evaporation and volumes.
• If using primary or aliquot tubes, use the sample gauge to ensure
sufficient patient specimen is present.
• ARCHITECT TSH Calibrators and Controls should be mixed by gentle
inversion prior to use.
• To obtain the recommended volume requirements for the ARCHITECT
TSH Calibrators and Controls, hold the bottles vertically and dispense
6 drops of each calibrator or 4 drops of each control into each
respective sample cup.
Calibration
• To perform an ARCHITECT TSH calibration, test Calibrators 1 and
2 in duplicate. A single sample of all levels of TSH controls must be
tested to evaluate the assay calibration. Ensure that assay control
values are within the concentration ranges specified in the package
insert. Calibrators should be priority loaded.
• Calibrator Range: 0.0000 - 100.0000 μIU/mL.
• Once an ARCHITECT TSH calibration is accepted and stored,
all subsequent samples may be tested without further calibration
unless:
• A reagent kit with a new lot number is used
• Controls are out of range
• For detailed information on how to perform an assay calibration, refer
to the ARCHITECT System Operations Manual, Section 6.
QUALITY CONTROL PROCEDURES
The recommended control requirement for the ARCHITECT TSH assay
is a single sample of all control levels tested once every 24 hours each
day of use. If the quality control procedures in your laboratory require
more frequent use of controls to verify test results, follow your laboratoryspecific procedures. Ensure that assay control values are within the
concentration ranges specified in the package insert.
4
Verification of Assay Claims
Total
Panel Reagent InstruMean Conc. Within Run
Member Lot
ment n (µIU/mL)
SD %CV SD %CV
1
1
1
80
0.0907 0.00160 1.8 0.00210 2.3
For protocols to verify package insert claims, refer to the ARCHITECT
System Operations Manual, Appendix B. The ARCHITECT TSH assay
belongs to method group 1. The lower limit of the dynamic range is
defined as the functional sensitivity of the assay.
RESULTS
The ARCHITECT TSH assay utilizes a 4 Parameter Logistic Curve fit data
reduction method (4PLC, Y weighted) to generate a calibration curve.
Alternate Result Units
• The default result unit for the ARCHITECT TSH assay is μIU/mL.
When the alternate result unit, mIU/L, is selected, the conversion
factor used by the system is 1.
• Conversion Formula: (Concentration in μIU/mL) x (1) = mIU/L.
Flags
• Some results may contain information in the Flags field. For a
description of the flags that may appear in this field, refer to the
• Specimens run on the ARCHITECT TSH assay MUST be processed
according to the specimen test tube manufacturer’s instruction.
Insufficient processing including deviations from recommended
clotting times, centrifugation times, centrifugation speed and sample
preparation techniques may cause inaccurate results.
• For diagnostic purposes, results should be used in conjunction with
other data; e.g., symptoms, results of other thyroid tests, clinical
impressions, etc.
• If the TSH results are inconsistent with clinical evidence, additional
testing is suggested to confirm the result.
• Suspected hyperthyroidism based on low or undetectable TSH levels
should be confirmed with additional thyroid function testing along with
other clinical information.
• Specimens from patients who have received preparations of mouse
monoclonal antibodies for diagnosis or therapy may contain human
anti-mouse antibodies (HAMA). Such specimens may show either
falsely elevated or depressed values when tested with assay
kits which employ mouse monoclonal antibodies.22,23 Additional
information may be required for diagnosis.
• Heterophilic antibodies in human serum can react with reagent
immunoglobulins, interfering with in vitro immunoassays.24 Patients
routinely exposed to animals or animal serum products can be
prone to this interference and anomalous values may be observed.
Additional information may be required for diagnosis.
1
1
2
80
0.0879
0.00121 1.4 0.00171 1.9
1
2
1
80
0.0876
0.00135 1.5 0.00225 2.6
1
2
2
80
0.0888
0.00440 5.0 0.00469 5.3
2
1
1
80
5.7062
0.08187 1.4 0.12184 2.1
2
1
2
80
5.4750
0.09116 1.7 0.12761 2.3
2
2
1
80
5.5153
0.08122 1.5 0.11008 2.0
0.08176 1.5 0.12501 2.3
2
2
2
80
5.5320
3
1
1
80
28.4388 0.44471
1.6 0.82863 2.9
3
1
2
80
27.0156 0.76916
2.8 1.03741 3.8
3
2
1
80
27.2486 0.58176
2.1 0.75194 2.8
3
2
2
80
28.0434 0.55278
2.0 0.92480 3.3
4
1
1
80
0.5217 0.00655
1.3 0.00894 1.7
4
1
2
80
0.5024 0.00751
1.5 0.01128 2.2
4
2
1
80
0.4998 0.00653
1.3 0.00973 1.9
4
2
2
80
0.5070 0.00562
1.1 0.01156 2.3
5
1
1
80
2.0057 0.02380
1.2 0.03367 1.7
5
1
2
80
1.9318 0.02679
1.4 0.03842 2.0
5
2
1
80
1.9060 0.03844
2.0 0.04405 2.3
5
2
2
80
1.9369 0.02747
1.4 0.03499 1.8
6
1
1
80
16.5485 0.28856
1.7 0.38175 2.3
6
1
2
80
15.8935 0.27310
1.7 0.41347 2.6
6
2
1
80
15.9947 0.25055
1.6 0.38375 2.4
6
2
2
80
16.3632 0.23302
1.4 0.41631 2.5
* Representative data; results in individual laboratories may vary from
these data.
Recovery
The ARCHITECT TSH assay is designed to have a mean recovery of
100 +/- 10% when analyzing samples spiked with known amounts of TSH.
TSH (spanning the dynamic range) was added to 10 aliquots of human
serum. The concentration of TSH was determined using the ARCHITECT
TSH assay and the resulting percent recovery was calculated.* The
percent recovery of the ARCHITECT TSH assay ranged from 91.8% to
104.3% with an average of 99.4%.
* Representative data; results in individual laboratories may vary from
these data.
EXPECTED VALUES
A normal range of 0.35 μIU/mL to 4.94 μIU/mL (99% confidence interval)
was obtained by testing serum specimens from 549 individuals defined
as normal by the AxSYM Ultrasensitive hTSH II and AxSYM Free T4
assays. It is recommended that each laboratory establish its own normal
range which may be unique to the population it serves depending upon
geographical, patient, dietary, or environmental factors.
Sensitivity
Functional
Functional sensitivity is defined as the concentration of TSH that can be
measured with an interassay CV of 20%.6 The ARCHITECT TSH assay is
designed to have a functional sensitivity of ≤ 0.01 μlU/mL, which meets
the requirements of a third generation TSH assay.
In a representative study, the functional sensitivity was calculated to
be ≤ 0.0038 μIU/mL (upper 95% confidence limit of 0.0042 μIU/mL). In
addition, a total %CV was calculated from the pooled data generated
using two lots of reagents and two instruments. The data exhibited a
functional sensitivity of ≤ 0.0036 μIU/mL (upper 95% confidence limit
of 0.0038 μIU/ mL). This was determined by testing human serum and
processed human serum samples ranging from 0.0007 μIU/mL to
0.2365 μIU/mL. Each sample was tested over 35 to 42 days on each
of two ARCHITECT i Systems using two reagent lots with at least 10
replicates per lot per instrument. The total and interassay %CVs were
calculated and plotted against the mean concentration. A reciprocal curve
was fitted through the data and the functional sensitivity was estimated as
the concentration corresponding to the 20% CV on the fitted curve.
Precision
The ARCHITECT TSH assay is designed to have a precision of ≤ 10% (total
CV). A study based on guidance from Clinical and Laboratory Standards
Institute (CLSI, formerly NCCLS) document EP5-A25 was performed for
the ARCHITECT TSH assay. Three buffer based panel members (1, 2
and 3) and three processed human serum based panel members (4, 5
and 6) were assayed, using two lots of reagents, in replicates of two at
two separate times per day for 20 testing days. Data from this study are
summarized in the following table.*
5
In this evaluation, serum specimens tested ranged from 0.0109 μIU/mL to
127.9816 μIU/mL with the ARCHITECT TSH assay.
* Representative data; variables such as differences in sampling size and
sample population may impact the correlation of the assay; therefore,
results in individual laboratories may vary from these data.
**A linear regression method with no special assumptions regarding the
distribution of the samples and the measurement errors.26
BIBLIOGRAPHY
1. Pierce JG. The Subunits of Pituitary Thyrotropin. Their Relationship to
other Glycoprotein Hormones. Endocrinology 1971; 89:1331-44.
2. Rees Smith B, Pyle GA, Petersen VB, Hall R. Interaction of
Thyrotropin with the Human Thyrotropin Receptor. J Endocrinol 1977;
75:391‑400.
3. Sterling K, Lazarus JH. The Thyroid and Its Control. Annu Rev Physiol
1977; 39:349-71.
4. Patel YC, Alford FP, Burger HG. The 24-Hour Plasma Thyrotropin
Profile. Clin Sci 1972; 43:71-7.
5. Morley JE. Neuroendocrine Control of Thyrotropin Secretion. Endocr
Rev 1981; 2:396-436.
6. Burger HG, Patel YC. The Value of Serum Thyrotropin Measurement
in the Diagnosis and Management of Hypothyroidism. Med J Aust
1972; 2:293-7.
7. Petersen VB, McGregor AM, Belchetz PE, Elkeles RS, Hall R.
The Secretion of Thyrotropin with Impaired Biological Activity in
Patients with Hypothalimic-Pituitary Disease. Clin Endocrinol 1978;
8:397‑402.
8. Faglia G, Bitensky L, Pinchera A, Ferrari C, Paracchi A, Beck‑Pecooz P,
et al. Thyrotropin Secretion in Patients with Central Hypothyroidism:
Evidence for Reduced Biological Activity of Immunoreactive
Thyrotropin. J Clin Endocrinol Metab 1979; 48:989-98.
9. Beck-Peccoz P, Amr S, Menezes-Ferreira MM, Faglia G, Weintraub BD.
Decreased Receptor Binding of Biologically Inactive Thyrotropin in
Central Hypothyroidism. N Engl J Med 1985; 312:1085‑90.
10. Wehmann RE, Rubenstein HA, Pugeat MM, Nisula BC, Extended
Clinical Utility of a Sensitive and Reliable Radioimmunoassay of
Thyroid-Stimulating Hormone. South Med J 1983; 76:969-76.
11. Lauridsen UB, Deckert T, Friis TH, Kirkegaard C, Hansen JM,
Siersbaek-Nielsen K. Estimation of Serum Thyrotropin (TSH) and
Stimulation with Thyrotropin-Releasing Hormone (TRH) in Thyroid
Diseases. Acta Med Scand 1974; 196:171-6.
12. Jackson IMD. Thyrotropin-Releasing Hormone. N Engl J Med 1982;
306:145-55.
13. Spencer CA. Clinical Uses and Limitations of Rapid TSH Assays.
Medical Laboratory Products 1988; 17-9.
14. Bayer MF. Performance Criteria for Appropriate Characterization of
“(Highly) Sensitive” Thyrotropin Assays. Clin Chem 1987; 33:630-1.
15. Hay ID, Bayer MF, Kaplan MM, Klee GG, Larsen PR, and Spencer CA.
American Thyroid Association Assessment of Current Free Thyroid
Hormone and Thyrotropin Measurements and Guidelines for Future
Clinical Assays. Clin Chem 1991; 37:2002-8.
16. The National Academy of Clinical Biochemistry: Standards of
Laboratory Practice. Laboratory Support for the Diagnosis &
Monitoring of Thyroid Disease. NACB, 1996.
17. Hay ID, Klee GG. Linking Medical Needs and Performance Goals:
Clinical and Laboratory Perspectives on Thyroid Disease. Clin Chem
1993; 39:1519-24.
Administration, 29 CFR Part 1910.1030, Bloodborne Pathogens.
Microbiological and Biomedical Laboratories. 5th ed. Washington,
DC: US Government Printing Office; January 2007.
20. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
21. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections: Approved Guideline
—Third Edition. CLSI Document M29-A3. Wayne, PA: Clinical and
Laboratory Standards Institute; 2005.
22. Primus FJ, Kelley EA, Hansen HJ, Goldenberg DM. “Sandwich”-Type
Immunoassay of Carcinoembryonic Antigen in Patients Receiving
Murine Monoclonal Antibodies for Diagnosis and Therapy. Clin Chem
1988; 34:261-4.
Analytical
The ARCHITECT TSH assay is designed to have an analytical sensitivity
of ≤ 0.0025 μIU/mL.
Analytical sensitivity is defined as the concentration calculated as the
mean plus two standard deviations of replicates of the ARCHITECT TSH
MasterCheck Level 0 (0.0 μIU/mL). The analytical sensitivity (low‑linearity)
is defined in the ARCHITECT TSH assay parameters as 0.0025 μIU/mL.
Analytical Specificity
The ARCHITECT TSH assay is designed to have an analytical specificity of
< 10% cross reactivity with the following substances, at the concentration
levels listed, in human serum samples containing TSH in the normal
range.
• FSH
- ≤ 500 mIU/mL
• LH
- ≤ 500 mIU/mL
• hCG
- ≤ 200,000 mIU/mL
Interference
The ARCHITECT TSH assay is designed to have a potential interference
from hemoglobin, bilirubin, triglycerides and protein of ≤ 10% at the levels
indicated below.
• Hemoglobin - ≤ 500 mg/dL
• Bilirubin
- ≤ 20 mg/dL
• Triglycerides - ≤ 3000 mg/dL
• Protein
- ≤ 2 g/dL and 12 g/dL
Accuracy by Correlation
The ARCHITECT TSH assay is designed to have a slope of 1.0 +/- 0.2
and a correlation coefficient (r) of ≥ 0.95 when compared to the AxSYM
Ultrasensitive hTSH II assay.
A study was performed where specimens were tested using the
ARCHITECT TSH assay and AxSYM Ultrasensitive hTSH II assay. Data
from this study were analyzed using least squares and Passing-Bablok26
regression methods and are summarized in the following table.*
Abbott ARCHITECT TSH vs. Abbott AxSYM Ultrasensitive hTSH II
Number of
Correlation
Method
Specimens Intercept
Slope
Coefficient
Least Squares
Linear Regression
534
-0.7135
0.96
0.987
Passing-Bablok
Linear Regression**
534
0.0098
0.91
0.987
6
23. Schroff RW, Foon KA, Beatty SM, Oldham RK, Morgan AC Jr.
Human Anti-Murine Immunoglobulin Responses in Patients Receiving
Monoclonal Antibody Therapy. Cancer Res 1985; 45:879-85.
24. Boscato LM and Stuart MC. Heterophilic Antibodies; A Problem for
All Immunoassays. Clin Chem 1988; 34:27.
25. National Committee for Clinical Laboratory Standards, Evaluation
of Precision Performance of Clinical Chemistry Devices - Approved
Guideline. NCCLS Document EP5-A. Wayne, PA: NCCLS, 1999.
26. Passing H, Bablok W. A New Biometrical Procedure for Testing the
Equality of Measurements from Two Different Analytical Methods.
J Clin Chem. Clin Biochem. 1983;21:709-20.
ARCHITECT, AxSYM, MasterCheck and Chemiflex are trademarks of
Abbott Laboratories in various jurisdictions.
Abbott Ireland
Diagnostics Division
Lisnamuck, Longford
Co. Longford
Ireland
+353-43-3331000
Distributed by Abbott Laboratories
and
ABBOTT 65205 Wiesbaden, Germany
June 2010
© 2005, 2010 Abbott Laboratories
7
es
TSH
SYSTEM
7K62-10
C7K623
G3-3941/R03
TSH Controls
Consulte las modificaciones marcadas
Revisado en noviembre de 2012
ALMACENAMIENTO
FINALIDAD DE USO
• Si se almacenan y se manejan según las instrucciones, los ARCHITECT
TSH Controls se mantienen estables hasta la fecha de caducidad.
• No los utilice una vez transcurrida la fecha de caducidad.
Los ARCHITECT TSH Controls se utilizan para la verificación de la
exactitud y la precisión del ARCHITECT i System en la determinación
cuantitativa de la hormona tiroestimulante humana (TSH) en suero y
plasma humanos. Si desea más información, consulte las instrucciones
de uso del ensayo ARCHITECT correspondiente.
•
CONTENIDO
3 frascos (8 ml cada uno) de ARCHITECT TSH Controls ( ,
,
), que contienen TSH (recombinante)
preparada en tampón TRIS con estabilizantes proteínicos (bovinos).
Conservante: azida sódica. Se pueden utilizar los siguientes intervalos
de valores para las especificaciones de los controles en el sistema
ARCHITECT:
Control
Concentración esperada
/ Intervalo de valores
µIU/ml
0,1
6
30
0,065 - 0,135
3,9 - 8,1
19,5 - 40,5
ARCHITECT es una marca comercial de Abbott Laboratories en varios
países.
Abbott Ireland
Lisnamuck, Longford
Co. Longford
Ireland
+353-43-3331000
Concentración esperada/
Intervalo de valores mIU/l
0,1
6
30
0,065 - 0,135
3,9 - 8,1
19,5 - 40,5
Distribuido por Abbott Laboratories
y
Cada laboratorio debe establecer sus propios intervalos de concentración
aceptables para cada lote de controles nuevo y para todas las
concentraciones de los controles. Para ello, se debe analizar un mínimo
de 20 replicados durante varios días (de 3 a 5 días). Entre las causas
de variaciones que se pueden dar y que se deben incluir en este estudio
para que sea representativo del funcionamiento futuro del sistema se
incluyen:
• Diversas calibraciones almacenadas
• Diversos lotes de reactivos
• Diversos lotes de calibradores
• Diferentes módulos de procesamiento
• Datos recogidos en diversos momentos del día
Estos resultados se deben utilizar en los procesos de control de calidad
de su laboratorio.
Noviembre 2012
Símbolos utilizados
Código GTIN, número mundial
de identificación de artículo
Producto de Irlanda
ESTANDARIZACIÓN
Información de interés sólo
para EE. UU.
Los controles se fabrican mediante la adición de concentraciones
conocidas de TSH humana recombinante para obtener una concentración
esperada. Esta concentración asignada internamente se establece con
valores de calibración que se correlacionan con el patrón 80/558 de la
OMS para la TSH.
PRECAUCIONES
•
• Para uso en diagnóstico in vitro
•
Contiene azida sódica. En contacto con ácidos
libera gases muy tóxicos.
• Elimínense los residuos del producto y sus recipientes con todas las
precauciones posibles.
• Las fichas de datos de seguridad están disponibles en la página
web www.abbottdiagnostics.com o a través de la Asistencia Técnica
de Abbott.
• Si desea más información sobre la eliminación correcta de los
reactivos que contienen azida sódica, consulte el capítulo 8 del
Manual de operaciones del sistema ARCHITECT.
1
es
TSH
system
7K62-01
S7K623
G3-3930/R03
TSH Calibrators
Consulte las modificaciones marcadas
Revisado en noviembre de 2012
FINALIDAD DE USO
ARCHITECT es una marca comercial de Abbott Laboratories en varios
países.
Los ARCHITECT TSH Calibrators se usan para la calibración del
ARCHITECT i System en la determinación cuantitativa de la hormona
tiroestimulante humana (TSH) en suero y plasma humanos. Si desea más
información, consulte las instrucciones de uso específicas del ensayo
ARCHITECT correspondiente.
Abbott Ireland
Lisnamuck, Longford
Co. Longford
Ireland
+353-43-3331000
CONTENIDO
2 frascos (4 ml cada uno) de ARCHITECT TSH Calibrators. El calibrador 1
(
) contiene tampón TRIS con estabilizantes proteínicos (bovinos).
El calibrator 2 (
) contiene TSH (recombinante) en tampón TRIS
con estabilizantes proteínicos (bovinos). Conservante: azida sódica.
Los calibradores presentan las concentraciones siguientes:
Concentración de TSH
Calibrador
(μIU/ml)
(mIU/l)
0
0
40
40
Distribuido por Abbott Laboratories
y
Noviembre 2012
ESTANDARIZACIÓN
Los calibradores se elaboran añadiendo una concentración conocida de
TSH humana recombinante para obtener una concentración deseada. La
concentración se ajusta al patrón 80/558 para TSH de la Organización
Mundial de la Salud (OMS).
Símbolos utilizados
Código GTIN, número mundial
de identificación de artículo
PRECAUCIONES
•
• Para uso en diagnóstico in vitro
•
Contiene azida sódica. En contacto con ácidos
libera gases muy tóxicos.
• Elimínense los residuos del producto y sus recipientes con todas las
precauciones posibles.
• Las fichas de datos de seguridad están disponibles en la página
web www.abbottdiagnostics.com o a través de la Asistencia Técnica
de Abbott.
• Si desea más información sobre la eliminación correcta de los
reactivos que contienen azida sódica, consulte el capítulo 8 del
Manual de operaciones del sistema ARCHITECT.
Producto de Irlanda
Información de interés sólo
para EE. UU.
ALMACENAMIENTO
• Si se almacenan y se manejan según las instrucciones, los ARCHITECT
TSH Calibrators se mantienen estables hasta la fecha de caducidad.
• No los utilice una vez transcurrida la fecha de caducidad.
•
1
en
25-OH Vitamin D
system
3L52
49-8941/R02
Read Highlighted Changes
Revised June 2011
25-OH Vitamin D
Customer Service: Contact your local representative or find country specific contact information
on www.abbottdiagnostics.com
Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any
deviations from the instructions in this package insert.
Key to symbols used
List Number
Control Number
In Vitro Diagnostic Medical
Device
Reaction Vessels
Sample Cups
Lot Number
Septum
Expiration Date
Replacement Caps
Serial Number
Warning: May cause
an allergic reaction
Store at 2-8°C
Contains sodium azide.
Contact with acids
liberates very toxic gas.
Manufacturer
Contains: Methanol
Assay CD-ROM - WW (excluding US) - Addition E
Assay CD-ROM - WW (excluding US) - Addition E
See REAGENTS section for a full explanation of symbols used in reagent
component naming.
1
NAME
•
1 Bottle (5.9 mL per 100-test bottle/26.3 mL per 500‑test
bottle) biotinylated vitamin D anti-biotin IgG (mouse, monoclonal)
acridinium-labeled conjugate complex in BIS-TRIS HCl buffer
with protein stabilizers (bovine gamma globulin) and detergent.
Minimum concentration: 1.2 μg/mL anti-biotin IgG and 0.1 μg/mL
vitamin‑D‑biotin. Preservative: sodium azide.
1 Bottle (4.9 mL per 100-test bottle/21.2 mL per
•
500-test bottle) Assay Diluent containing acetic acid buffer with EDTA.
Preservatives: ProClin 300, ProClin 950.
•
500-test bottle) Pre-Treatment 1 containing triethanolamine methanol
buffer and 8-anilino-1-naphtalensulfonic acid (ANSA).
•
500-test bottle) Pre-Treatment 2 containing triethanolamine methanol
buffer and 8-anilino-1-naphtalensulfonic acid (ANSA).
ARCHITECT 25-OH Vitamin D
INTENDED USE
The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent
microparticle immunoassay (CMIA) for the quantitative determination of
25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.
The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the
assessment of vitamin D sufficiency.
Vitamin D is a fat-soluble steroid prohormone mainly produced
photochemically in the skin from 7-dehydrocholesterol.
Two forms of vitamin D are biologically relevant – vitamin D3 (Cholecalciferol)
and vitamin D2 (Ergocalciferol). Both vitamins D3 and D2 can be absorbed
from food, with vitamin D2 being an artificial source, but only an estimated
10-20% of vitamin D is supplied through nutritional intake.1 Vitamins D3
and D2 can be found in vitamin supplements. Vitamin D is converted
to the active hormone 1,25-(OH)2-vitamin D (Calcitriol) through two
hydroxylation reactions. The first hydroxylation converts vitamin D into
25‑OH vitamin D and occurs in the liver. The second hydroxylation converts
25-OH vitamin D into the biologically active 1,25-(OH)2-vitamin D and
occurs in the kidneys as well as in many other cells of the body. Most
cells express the vitamin D receptor and about 3% of the human genome
is directly or indirectly regulated by the vitamin D endocrine system.1
The major storage form of vitamin D is 25-OH vitamin D and is present
in the blood at up to 1,000 fold higher concentration compared to the
active 1,25-(OH)2-vitamin D. 25-OH vitamin D has a half-life of 2-3 weeks
vs. 4 hours for 1,25-(OH)2-vitamin D. Therefore, 25-OH vitamin D is the
analyte of choice for determination of the vitamin D status.2,3
Epidemiological studies have shown a high global prevalence of vitamin D
insufficiency and deficiency.4 The measurement of vitamin D status
provides opportunities for preventive and therapeutic interventions.5,6,7
Vitamin D deficiency is a cause of secondary hyperparathyroidism and
diseases resulting in impaired bone metabolism (like rickets, osteoporosis,
osteomalacia).2,8,9 Reduced 25-OH vitamin D concentrations in blood
(vitamin D insufficiency) have been associated with an increasing risk
of many chronic diseases, including common cancers, autoimmune or
infectious diseases or cardiovascular problems.1,2,6,8,10-12
Other Reagents
ARCHITECT i Pre-Trigger Solution
•
Pre-trigger solution containing 1.32% (w/v)
hydrogen peroxide.
ARCHITECT i Trigger Solution
Trigger solution containing 0.35N sodium
•
hydroxide.
ARCHITECT i Wash Buffer
•
Wash buffer containing phosphate buffered saline
solution. Preservatives: antimicrobial agents.
•
• For In Vitro Diagnostic Use.
Package insert instructions must be carefully followed. Reliability of
assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Safety Precautions
• CAUTION: This product requires the handling of human specimens.
It is recommended that all human-sourced materials be considered
potentially infectious and handled in accordance with the OSHA
• This product contains sodium azide; for a specific listing, refer to the
REAGENTS section. Contact with acids liberates very toxic gas. This
material and its container must be disposed of in a safe way.
• The following warnings and precautions apply to these components:
• Microparticles
• Assay Diluent
BIOLOGICAL PRINCIPLES OF THE PROCEDURE
The ARCHITECT 25-OH Vitamin D assay is a delayed one-step
immunoassay including a sample pre-treatment for the quantitative
determination of vitamin D in human serum and plasma using CMIA
technology with flexible assay protocols, referred to as Chemiflex.
Sample and pre-treatment reagent are combined. An aliquot of the
pre‑treated sample is combined with assay diluent and paramagnetic
anti‑vitamin D coated microparticles to create a reaction mixture. Vitamin D
present in the sample binds to anti-vitamin D coated microparticles. After
incubation a biotinylated vitamin D anti-Biotin acridinium-labeled conjugate
complex is added to the reaction mixture and binds to unoccupied binding
sites of the anti-vitamin D coated microparticles. After washing, pre-trigger
and trigger solutions are added to the reaction mixture. The resulting
chemiluminescent reaction is measured as relative light units (RLUs). An
indirect relationship exists between the amount of vitamin D in the sample
and the RLUs detected by the ARCHITECT i System optics.
For additional information on system and assay technology, refer to the
WARNING:
Contains methylisothiazolones.
H317
May cause an allergic skin reaction.
Prevention
P261
P272
P280
REAGENTS
Avoid breathing mist/vapours/spray.
Contaminated work clothing should not be
allowed out of the workplace.
Wear protective gloves/protective clothing/eye
protection.
Response
Reagent Kit, 100 Tests/500 Tests
P302+P352
P333+P313
NOTE: Some kit sizes are not available in all countries or for use on all
ARCHITECT i Systems. Please contact your local distributor.
ARCHITECT Reagent Kit (3L52)
•
500-test bottle) Anti-human vitamin D IgG (sheep, polyclonal) coated
microparticles in TRIS buffer. Minimum concentration: 0.05% solids.
Preservatives: ProClin 300, ProClin 950.
P363
IF ON SKIN: Wash with plenty of water.
If skin irritation or rash occurs: Get medical
advice/attention.
Wash contaminated clothing before reuse.
2
Storage Instructions
• The following warnings and precautions apply to these components:
• Pre-Treatment 1
• Pre-Treatment 2
DANGER:
Contains methanol.
H226
H332
H370
Prevention
Flammable liquid and vapour.
Harmful if inhaled.
Causes damage to organs.
P210
P233
Keep away from heat/sparks/open flames/hot
surfaces. No smoking.
Take precautionary measures against static
discharge.
Keep container tightly closed.
P271
Use only in a well-ventilated area.
P260
P280
Do not breathe mist/vapours/spray.
Wear protective gloves/protective clothing/eye
protection.
Wash hands thoroughly after handling.
P243
P264
Response
P304+P340
P303+P361+
P353
P307+P311
Storage
P403+P235
P405
•
•
•
•
•
•
IF INHALED: Remove victim to fresh air and
keep at rest in a position comfortable for
breathing.
IF ON SKIN (or hair): Remove/Take off
immediately all contaminated clothing. Rinse
skin with water/shower.
IF EXPOSED: Call a POISON CENTER or
doctor/physician.
The ARCHITECT 25-OH Vitamin D Reagent Kit must be
stored at 2-8°C in an upright position and may be used immediately
after removal from 2-8°C storage.
When stored and handled as directed, reagents are stable until the
expiration date.
The conjugate is temperature sensitive, minimize room temperature
exposure of conjugate bottle.
The ARCHITECT Reagent Kit may be stored on board the ARCHITECT
i System for a maximum of 14 days.
After these maximum storage times, the reagent kit must be discarded.
For information on tracking onboard time, refer to the ARCHITECT
Reagents may be stored on or off the ARCHITECT i System. If
reagents are removed from the system, store them at 2-8°C (with
septums and replacement caps) in an upright position. For reagents
stored off the system, it is recommended that they be stored
in their original trays and boxes to ensure they remain upright. If
the microparticle bottle does not remain upright (with a septum
installed) while in refrigerated storage off the system, the reagent
kit must be discarded. For information on unloading reagents, refer
Indications of Reagent Deterioration
When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test
results are invalid and samples must be retested. Assay recalibration may
be necessary. For troubleshooting information, refer to the ARCHITECT
INSTRUMENT PROCEDURE
• The ARCHITECT 25-OH Vitamin D assay requires:
• ARCHITECT i System e-Assay CD-ROM found on
www.abbottdiagnostics.com under Support/Technical Library/
Assay Files or
• ARCHITECT i System Assay CD-ROM - WW (excluding US) Addition E.
• The ARCHITECT 25-OH Vitamin D assay file must be installed on
the ARCHITECT i System before performing the assay. For detailed
information on assay file installation and on viewing and editing assay
parameters, refer to the ARCHITECT System Operations Manual,
Section 2.
• For information on printing assay parameters, refer to the ARCHITECT
• For a detailed description of system procedures, refer to the
ARCHITECT System Operations Manual.
• The default result unit for the ARCHITECT 25-OH Vitamin D assay is
ng/mL. An alternate result unit, nmol/L, may be selected for reporting
results by editing assay parameter “Result concentration units” to
nmol/L. The conversion factor used by the system is 2.5.
Store in a well-ventilated place. Keep cool.
Store locked up.
• For information on the safe disposal of sodium azide and a detailed
discussion of safety precautions during system operation, refer to the
Handling Precautions
• Do not use reagent kits beyond the expiration date.
• Do not pool reagents within a kit or between reagent kits.
• The conjugate is temperature sensitive, minimize room temperature
exposure of conjugate bottle.
• Before loading the ARCHITECT 25-OH Vitamin D Reagent Kit on
the system for the first time, the microparticle bottle requires mixing
to resuspend microparticles that have settled during shipment. For
microparticle mixing instructions, refer to the PROCEDURE, Assay
Procedure section of this package insert.
• Septums MUST be used to prevent reagent evaporation and
contamination and to ensure reagent integrity. Reliability of assay
results cannot be guaranteed if septums are not used according to
• To avoid contamination, wear clean gloves when placing a septum on
an uncapped reagent bottle.
• Once a septum has been placed on the reagent bottle, do not
invert the bottle as this will result in reagent leakage and may
compromise assay results.
• Over time, residual liquids may dry on the septum surface. These
are typically dried salts, which have no effect on assay efficacy.
• For a detailed discussion of handling precautions during system
Section 7.
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
Specimen Types
The specimen collection tubes listed below were verified to be used with
the ARCHITECT 25-OH Vitamin D assay. Other specimen collection tubes
have not been tested with this assay.
• Human serum (including serum collected in serum separator tubes)
• Human plasma collected in:
• Potassium-EDTA
• Lithium heparin (powder or gel)
• Sodium heparin
• Human plasma collected in sodium citrate tube types showed a mean
bias of -13% versus serum.
• Other liquid anticoagulants may also have a dilution effect resulting in
lower concentrations for individual patient specimens.
• The ARCHITECT i System does not provide the capability to verify
specimen type. It is the responsibility of the operator to verify that the
correct specimen types are used in the ARCHITECT 25-OH Vitamin D
assay.
3
Specimen Conditions
•
•
•
•
•
•
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
ARCHITECT i
Pipettes or pipette tips (optional) to deliver the volumes specified on
the patient or control order screen.
For information on materials required for maintenance procedures, refer to
the ARCHITECT System Operations Manual, Section 9.
• Do not use specimens with the following conditions:
• heat-inactivated
• pooled
• grossly hemolyzed (> 500 mg/dL hemoglobin)
• obvious microbial contamination
• cadaver specimens or any other body fluids
• For accurate results, serum and plasma specimens should be free of
fibrin, red blood cells, and other particulate matter. Serum specimens
from patients receiving anticoagulant or thrombolytic therapy may
contain fibrin due to incomplete clot formation.
• Use caution when handling patient specimens to prevent cross
contamination. Use of disposable pipettes or pipette tips is
recommended.
• For optimal results, inspect all specimens for bubbles. Remove
bubbles with an applicator stick before analysis. Use a new applicator
stick for each specimen to prevent cross contamination.
Assay Procedure
• Before loading the ARCHITECT 25-OH Vitamin D Reagent Kit on the
system for the first time, the microparticle bottle requires mixing to
resuspend microparticles that have settled during shipment. After the
first time the microparticles have been loaded, no further mixing is
required.
• Invert the microparticle bottle 30 times.
• Visually inspect the bottle to ensure microparticles are
resuspended. If microparticles remain adhered to the bottle,
continue inverting the bottle until the microparticles have been
completely resuspended.
• If the microparticles do not resuspend, DO NOT USE. Contact
your local Abbott representative.
• Once the microparticles have been resuspended, place a septum
on the bottle. For instructions on placing septums on bottles refer
to the Handling Precautions section of this package insert.
• Load the ARCHITECT 25-OH Vitamin D Reagent Kit on the ARCHITECT
i System.
• Verify that all necessary assay reagents are present.
• Ensure that septums are present on all reagent bottles.
• Order calibration, if necessary.
• For information on ordering calibrations, refer to the ARCHITECT
• Order tests.
• For information on ordering patient specimens and controls and
for general operating procedures, refer to the ARCHITECT System
Operations Manual, Section 5.
• The minimum sample cup volume is calculated by the system and
is printed on the Orderlist report. No more than 10 replicates may
be sampled from the same sample cup. To minimize the effects of
evaporation, verify adequate sample cup volume is present before
running the test.
• Priority: 60 μL for the first ARCHITECT 25-OH Vitamin D test plus
10 μL for each additional ARCHITECT 25-OH Vitamin D test from
the same sample cup.
• ≤ 3 hours on board: 150 µl for the first ARCHITECT 25-OH
Vitamin D test plus 10 µl for each additional ARCHITECT 25-OH
Vitamin D test from the same sample cup.
• > 3 hours on board: additional sample volume is required. For
information on sample evaporation and volumes, refer to the
• If using primary or aliquot tubes, use the sample gauge to ensure
sufficient patient specimen is present.
• Prepare calibrators and controls.
• Mix ARCHITECT 25-OH Vitamin D Calibrators and Controls by
gentle inversion before use.
• To obtain the recommended volume requirements for the
ARCHITECT 25-OH Vitamin D Calibrators and Controls, hold the
bottles vertically and dispense 5 drops of each calibrator or
5 drops of each control into each respective sample cup.
• Load samples.
• For information on loading samples, refer to the ARCHITECT
• Press RUN.
• For additional information on principles of operation, refer to the
ARCHITECT Operations Manual, Section 3.
• For optimal performance, it is important to perform routine
maintenance as described in the ARCHITECT System Operations
Manual, Section 9. Perform maintenance more frequently when
required by laboratory procedures.
Preparation for Analysis
• Follow the tube manufacturer’s processing instructions for serum
and plasma collection tubes. Gravity separation is not sufficient for
specimen preparation.
• Mix thawed specimens thoroughly by low speed vortexing or by
inverting 10 times. Visually inspect the specimens. If layering or
stratification is observed, continue mixing until specimens are visibly
homogeneous.
• To ensure consistency in results, specimens must be transferred to a
centrifuge tube and centrifuged at ≥ 10000 RCF (Relative Centrifugal
Force) for 10 minutes before testing if
• they contain fibrin, red blood cells, or other particulate matter,
• they require repeat testing, or
• they were frozen and thawed.
Transfer clarified specimen to a sample cup or secondary tube for
testing.
• Centrifuged specimens with a lipid layer on the top must be transferred
to a sample cup or secondary tube. Care must be taken to transfer
only the clarified specimen without the lipemic material.
Storage
• Specimens may be stored on or off the clot or red blood cells for:
• up to 12 days at 2-8°C or
• up to 72 hours at 15-30°C
• If testing will be delayed more than 12 days, remove serum or plasma
from the clot or red blood cells and store frozen at -20°C or colder.
• Specimens stored frozen for 3 months showed no performance
difference. Avoid more than 4 freeze/thaw cycles.
Shipping
• Before shipping specimens, it is recommended that specimens be
removed from the clot, red blood cells, or separator gel.
• When shipping specimens, package and label specimens in compliance
with applicable state, federal, and international regulations covering
the transport of clinical specimens and infectious substances.
• Specimens may be shipped: ambient, on wet ice, on dry ice. Do not
exceed the storage time limitations listed above.
PROCEDURE
Materials Provided
• 3L52 ARCHITECT 25-OH Vitamin D Reagent Kit
• ARCHITECT i System
• 1L66 ARCHITECT i System
•
•
•
•
•
Assay CD-ROM - WW (excluding US) - Addition E , Version 9.0 or
higher or
ARCHITECT i System e-Assay CD-ROM found on
www.abbottdiagnostics.com under Support/Technical Library/Assay
Files.
3L52-01 ARCHITECT 25-OH Vitamin D Calibrators
3L52-10 ARCHITECT 25-OH Vitamin D Controls
ARCHITECT i
ARCHITECT i
4
• Specimens from patients who have received preparations of mouse
monoclonal antibodies for diagnosis or therapy may contain human
anti-mouse antibodies (HAMA).18,19 Specimens containing HAMA
may produce anomalous values when tested with assay kits that
employ mouse monoclonal antibodies.18
Specimens with a 25-OH vitamin D concentration > 160.0 ng/mL
(> 400.0 nmol/L) will be flagged as “>160.0 ng/mL” (“>400.0 nmol/L”) and
may be diluted with a specimen with a low 25-OH vitamin D concentration
≤ 10.7 ng/mL (≤ 26.8 nmol/L).
Manual dilutions should be performed as follows: Add 100 μL of the
patient specimen to 100 μL of a specimen with a low 25-OH vitamin D
concentration (i.e. 1:2 dilution).
Concentration (Conc.) calculations are performed as follows:
Conc. (high specimen) = Conc. (1:2 diluted specimen) x 2 - Conc. (low specimen)
EXPECTED VALUES
It is recommended that each laboratory establish its own reference
range, which may be unique to the population it serves depending upon
geographical, season, patient, dietary, or environmental factors.
A reference range study was conducted based on guidance from the
Clinical Laboratory and Standards Institute (CLSI), Protocol C28-A320.
Serum specimens of apparently healthy individuals from the Netherlands,
collected during summertime (June to August) and wintertime (March to
May, November and December) were evaluated in replicates of one using
the ARCHITECT 25-OH Vitamin D assay. A medical questionnaire has
been used to select the reference sample group based on the following
inclusion criteria: age between 17 and 60 years, normal nutrition habits
(no diet), no food supplements, no bone disease or rheumatism, no recent
sunny vacation or sunbath, no current hospital treatment, no chronic
disease (especially diabetes, renal failure, high cholesterol). In addition,
individuals have been excluded when showing results out of the expected
values for i PTH (15.0 – 68.3 pg/mL) and calcium (2.10 – 2.55 mmol/L).
The observed values are summarized in the following table.*
Calibration
• The ARCHITECT 25-OH Vitamin D assay requires a 7-days
recalibration interval.
• To perform an ARCHITECT 25-OH Vitamin D calibration, test
calibrators A, B, C, D, E, and F in replicates of two. A single sample
of each 25-OH vitamin D control level must be tested to evaluate
the assay calibration. Ensure that assay control values are within
the concentration ranges specified in the control package insert.
Calibrators should be priority loaded.
• Calibration Range: 0.0 to 160.0 ng/mL (0.0 to 400.0 nmol/L).
• For detailed information on how to perform an assay calibration, refer
QUALITY CONTROL PROCEDURES
The recommended control requirement for the ARCHITECT 25-OH
Vitamin D assay is that a single sample of each control be tested
once every 24 hours each day of use. If your laboratory quality control
procedures require more frequent use of controls to verify test results,
follow those procedures.
Additional controls may be tested in conformance with local, state,
and/or federal regulations or accreditation requirements and your
laboratory´s quality control procedure.
Each laboratory should establish control ranges to monitor the acceptable
performance of the assay. If a control is out of its specified range,
the associated test results are invalid and samples must be retested.
Recalibration may be indicated.
n
2.5th Percentile
97.5th Percentile
All
360
9.5
55.5
Season
Gender
Summer- WinterFemale Male
time
time
Unit
178
182
120
240
9.4
9.4
15.7
8.8 ng/mL
59.1
52.4
60.3
46.3 ng/mL
* Representative data; results in individual laboratories and in different
geographical areas may vary from these data.
There is currently debate over the recommended target range of vitamin D
in serum, but an expert panel recently suggested a target range of at least
30 - 40 ng/mL.21
Verification of Assay Claims
Data in the section SPECIFIC PERFORMANCE CHARACTERISTICS were
generated using the ARCHITECT i2000SR System.
Assay results obtained in individual laboratories may vary from data
presented.
For protocols to verify package insert claims, refer to the ARCHITECT
System Operations Manual, Appendix B. The ARCHITECT 25-OH
Vitamin D assay belongs to method group 2.
RESULTS
Precision
The ARCHITECT 25-OH Vitamin D assay uses a 4 Parameter Logistic
Curve fit (4PLC, Y-weighted) data reduction method to generate a
calibration curve.
The ARCHITECT 25-OH Vitamin D assay is designed to have an imprecision
of ≤ 10% Within Laboratory (total) CV.
A study was performed with the ARCHITECT 25-OH Vitamin D assay
based on guidance from the National Committee for Clinical Laboratory
Standards (NCCLS) Protocol EP5-A222. Six samples consisting of
3 ARCHITECT 25-OH Vitamin D Controls and 3 serum based panels were
assayed, using two lots of reagents, on one instrument, in replicates of
two at two separate times per day for 20 days. Data from this study are
summarized in the following table.
Calculation
The ARCHITECT i System calculates the Calibrator A through F mean
chemiluminescent signal from two Calibrator A through F replicates,
generates a calibration curve and stores the result. The default result unit
for the ARCHITECT 25-OH Vitamin D assay is ng/mL.
Flags
Some results may contain information in the Flags field. For a description
of the flags that may appear in this field, refer to the ARCHITECT System
Operations Manual, Section 5.
Sample
Low
Control
Measuring Interval (Reportable Range)
The measuring interval of the ARCHITECT 25-OH Vitamin D assay is
8.0 ng/mL to 160.0 ng/mL (20.0 nmol/L to 400.0 nmol/L).
Medium
Control
• If the vitamin D results are inconsistent with clinical evidence,
additional testing is suggested to confirm the result.
• For diagnostic purposes, results should be used in conjunction with
other data; e.g., symptoms, results of other tests, clinical impressions,
etc.
• Heterophilic antibodies in human serum can react with reagent
immunoglobulins, interfering with in vitro immunoassays.17 Patients
routinely exposed to animals or to animal serum products can be
prone to this interference and anomalous values may be observed.
Additional information may be required for diagnosis.
High
Control
Serum
Panel 1
Serum
Panel 2
Serum
Panel 3
5
Reagent
Lot
1
2
1
2
1
2
1
2
1
2
1
2
n
80
80
80
80
80
80
80
80
80
80
80
80
Mean
Conc.
(ng/mL)
19.0
19.5
38.5
38.0
78.4
76.3
23.0
22.4
42.5
40.1
75.4
71.3
Within Run
SD
%CV
0.709
3.7
0.589
3.0
0.873
2.3
0.879
2.3
1.470
1.9
1.485
1.9
0.714
3.1
0.548
2.4
1.095
2.6
0.668
1.7
1.088
1.4
1.242
1.7
Within Laboratory
(total)
SD
%CV
0.712
3.8
0.889
4.6
1.142
3.0
1.062
2.8
2.201
2.8
2.034
2.7
0.912
4.0
0.780
3.5
1.346
3.2
1.274
3.2
2.064
2.7
1.869
2.6
Linear Range
Interference was demonstrated by a study based on guidance from
the CLSI Protocol EP7-A2. Data from this study are summarized in the
following table.
Based on guidance from the NCCLS Protocol EP6-A23 a study was
performed to establish the linear range of the ARCHITECT 25-OH
Vitamin D assay.
Four sample pairs were prepared with 11 dilutions for each pair by
mixing a high 25-OH vitamin D sample (in the range from 78.4 ng/mL to
165.5 ng/ mL) in specific ratios with a low 25-OH vitamin D sample (in the
range from 0.2 ng/mL to 10.7 ng/mL) and tested using the ARCHITECT
25-OH Vitamin D assay. Using an absolute deviation from linearity of
≤ 20% a linear range of 9.4 ng/mL to 165.5 ng/mL was established for the
ARCHITECT 25-OH Vitamin D assay.
Potentially Interfering
Substance
Hemoglobinb
Bilirubin
Triglycerides
Protein (Human Albumin)
Rheumatoid Factorc
HAMA
Red blood cells
Measuring Interval
Measuring interval is defined as the range of values in ng/mL which
meets the limits of acceptable performance for both imprecision and bias
for an undiluted sample. For the verification studies described in this
package insert, the range was 8.0 ng/mL to 160.0 ng/mL (20.0 nmol/L
to 400.0 nmol/L).
500 mg/dL the % Recovery ranged from 90% to 62%.
c For rheumatoid factors with concentrations between 400 IU/mL and
800 IU/mL the % Recovery ranged from 107% to 118%.
Method Comparison
The ARCHITECT 25-OH Vitamin D assay is designed to have a correlation
coefficient of ≥ 0.80 for serum samples when evaluated against the
DiaSorin LIAISON 25-OH Vitamin D Total.
A study was performed with the ARCHITECT 25-OH Vitamin D assay,
where regression analysis was performed using the Passing-Bablok26
method. Data from this study are summarized in the following table and
graph.*
Specificity
Regression
Method
PassingBabloka
The specificity of the ARCHITECT 25-OH Vitamin D assay was assessed
by testing the Cross-Reactants listed in the table below.
A study was performed with the ARCHITECT 25-OH Vitamin D assay based
on guidance from the CLSI Protocol EP7-A225. Aliquots of ARCHITECT
25-OH Vitamin D Calibrator A were supplemented with potential
Cross-Reactants at the concentrations listed and tested for 25-OH
vitamin D. Data from this study are summarized in the following table.
a % Cross-Reactivity =
x 100
b
For hemoglobin with concentrations between 200 mg/dL and
The ARCHITECT 25-OH Vitamin D assay is designed to have a Limit of
Blank (LoB) of ≤ 4.0 ng/mL, a Limit of Detection (LoD) of ≤ 10.0 ng/mL
and a Limit of Quantitation (LoQ) of ≤ 20 ng/mL.
Based on guidance from the NCCLS Protocol EP17-A24 a study was
performed with 4 zero-level samples (Calibrator A) and 8 samples with
25-OH vitamin D concentrations ranging from 3.4 ng/mL to 9.5 ng/ mL.
These samples were tested in 5 separate runs over a minimum of 5 days
using two reagent lots and two instruments.
In the above described study the LoB was 1.9 ng/mL, the LoD was
3.1 ng/ mL and the LoQ was 8.0 ng/mL.
Concentration
ng/mL
100
1000
1000
20
100
100
24
Mean Observed Value (ng/mL)
Mean Control Value (ng/mL)
a % Recovery =
Sensitivity
Cross-Reactant
25-OH vitamin D3
Vitamin-D2 (Ergocalciferol)
Vitamin-D3 (Cholecalciferol)
24,25-(OH)2-vitamin D3
1,25-(OH)2-vitamin D3
3-epi 25-OH vitamin D3
Paricalcitol (Zemplar)
Range of
% Recoverya
91 - 98
100 - 104
94 - 103
90 - 102
106 - 109
96 - 99
99 - 103
Concentration
200 mg/dL
20 mg/dL
5000 mg/dL
12 g/dL
400 IU/mL
1000 ng/mL
0.4 %(v/v)
n
Slope
Intercept
Correlation
Coefficient
108
1.02
-0.54
0.94
a A linear regression method with no special assumptions regarding the
distribution of the samples and measurement errors.
* Representative data; variables such as differences in sampling size and
sample population may impact the correlation of the assay, therefore,
results in individual laboratories may vary from these data.
In this evaluation, serum specimen concentrations ranged from 8.2 ng/ mL
to 70.5 ng/mL with the ARCHITECT 25-OH Vitamin D assay and from
5.1 ng/mL to 63.2 ng/mL with the DiaSorin LIAISON 25-OH Vitamin D
Total. The specimens included in the study are sourced from a clinical
research organization.
% CrossReactivitya
105
0.1
0.3
112
12.6
2.7
0.4
vs.
DiaSorin LIAISON 25-OH Vitamin D Total (Passing-Bablok)
Mean Value spiked (ng/mL) Mean Value non spiked (ng/mL)
x 100
Concentration of Cross-Reactant (ng/mL)
The 25-OH vitamin D2 % Cross-Reactivity* has been determined using
endogenous (non-spiked) serum samples. The samples were analyzed
with a chromatographic method (LC-MS/MS) in order to determine
25‑OH vitamin D2 and 25-OH vitamin D3 concentration. Samples
have been included in the testing that showed a 25-OH vitamin D2
to 25‑OH vitamin D3 ratio of ≥ 10 and 25-OH vitamin D3 concentration
< 5.0 ng/mL.
25‑OH vitamin Total (Arch) 25‑OH vitamin D3 (LC – MS/MS) x 100
* D2 % Cross-Reactivity =
25‑OH vitamin D2 (LC – MS/MS)
The mean D2 % Cross-Reactivity for ARCHITECT 25-OH Vitamin D was 82.
Interference
Potential interference in the ARCHITECT 25-OH Vitamin D assay from
hemoglobin, bilirubin, triglycerides, protein, rheumatoid factor, HAMA and
red blood cells is designed to be ≤ 10%.
DiaSorin LIAISON 25-OH Vitamin D Total (ng/mL)
6
8. Bischoff-Ferrari HA, Estimation of optimal serum concentrations of
25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr
2006;84:18-28.
9. Steingrimsdottir L, Relationship between serum parathyroid hormone
Levels, vitamin D sufficiency, and calcium intake. JAMA 2005;
294(18):2336-41.
10. Grant WB, Current impediments to acceptance of the ultraviolet-Bvitamin D-cancer hypothesis. Anticancer Res. 2009;29:3597-604.
11. Pilz S, Low vitamin D levels predict stroke in patients referred to
coronary angiography. Stroke 2008;9:2611-13.
12. Bischoff-Ferrari HA, Fall prevention with supplemental and active
forms of vitamin D: a meta-analysis of randomised controlled trials.
BMJ 2009;339:b3692.
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
microbiological and biomedical laboratories. 5th ed. Washington, DC:
US Government Printing Office; January 2007.
15. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
16. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections: Approved
Guideline—Third Edition. CLSI Document M29-A3. Wayne, PA: Clinical
and Laboratory Standards Institute; 2005.
17. Boscato, LM and Stuart, MC. Heterophilic antibodies; A problem for
all immunoassays. Clin Chem 1988;34:27.
18. Primus FJ, Kelley EA, Hansen HJ, et al. “Sandwich”-type immunoassay
of carcinoembryonic antigen in patients receiving murine monoclonal
antibodies for diagnosis and therapy. Clin Chem 1988;34:261-4.
19. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine
immunoglobulin responses in patients receiving monoclonal antibody
therapy. Cancer Res 1985;45:879-85.
20. Clinical and Laboratory Standards Institute. Defining, Establishing,
and Verifying Reference Intervals in the Clinical Laboratory: Approved
Guideline - Third Edition. CLSI Document C28-A3. Wayne, PA: Clinical
and Laboratory Standards Institute, 2008.
21. Souberbielle JC, Vitamin D and musculoskeletal health, cardiovascular
disease, autoimmunity and cancer: Recommendations for clinical
practice. Autoimmun Rev 2010;9:709-715.
22. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline—Second Edition. NCCLS document
EP5-A2 Wayne, PA: NCCLS, 2004.
Evaluation of the Linearity of Quantitative Measurement Procedures:
A Statistical Approach; Approved Guideline. NCCLS document EP6-A.
Wayne, PA: NCCLS; 2003.
Protocols for Determination of Limits of Detection and Limits of
Quantitation; Approved Guideline. NCCLS document EP17-A, Wayne,
PA: NCCLS, 2004.
25. Clinical and Laboratory Standards Institute. Interference Testing
in Clinical Chemistry: Approved Guideline - Second Edition. CLSI
Document EP7-A2. Wayne, PA: Clinical and Laboratory Standards
Institute, 2005.
26. Passing HA, Bablok W. New biometrical procedure for testing the
equality of measurements from two different analytical methods. J Clin
Chem Clin Biochem 1983;21:709-20.
27. Wallace AM, Measurement of 25-hydroxyvitamin D in the clinical
laboratory: Current procedures, performance characteristics and
limitations. Steroids 2010;75:477-488.
The same specimens have been measured with a chromatographic method
(LC-MS/MS) and evaluated against the ARCHITECT 25-OH Vitamin D
assay. The regression analysis was performed using the Passing-Bablok
method. Data from this study are summarized in the following table and
graph.*
Regression
Method
PassingBabloka
n
Slope
Intercept
Correlation
Coefficient
107
1.01
- 1.45
0.90
a A linear regression method with no special assumptions regarding the
distribution of the samples and measurement errors.
* Representative data; variables such as differences in sampling size
and sample population may impact the correlation of the assay,
therefore, results in individual laboratories may vary from these data.
Additionally, LC-MS/MS methodology variables, such as extraction
method, ionization method, type of chromatographic separation and
type of internal standard may impact the LC-MS/MS results; therefore
results in individual laboratories may vary from these data.27
In this evaluation, serum specimen concentrations ranged from
8.2 ng/mL to 70.5 ng/mL with the ARCHITECT 25-OH Vitamin D assay and
from 7.5 ng/mL to 64.4 ng/mL with the LC-MS/MS test method.
vs.
LC-MS/MS 25-OH Vitamin D (Passing-Bablok)
LC-MS/MS 25-OH Vitamin D (ng/mL)
BIBLIOGRAPHY
1. Pilz S, Vitamin D status and arterial hypertension: a systematic
review. Nat. Rev. Cardiol. 2009;6:621-30.
2. Souberbielle JC, Evaluating vitamin D status. Implications for
preventing and managing osteoporosis and other chronic diseases.
Joint Bone Spine 2006;73:249-53.
3. Cavalier E, Vitamin D: current status and perspectives. Clin Chem Lab
Med 2009;47(2):120-27.
4. Peterlik M, Vitamin D and calcium insufficiency-related chronic
diseases: an emerging world-wide public health problem. Int. J.
Environ. Res. Public Health 2009;6:2585-607.
5. Grant WB, Estimated benefit of increased vitamin D status in reducing
the economic burden of disease in western Europe. Prog. Biophys.
Mol. Biol. 2009;99:104-13.
6. Holick MF, Vitamin D deficiency. N. Engl. J. Med. 2007;357:266-81.
7. Autier P, Vitamin D supplementation and total mortality: A metaanalysis of randomized controlled trials. Arch Intern Med. 2007;
167(16):1730-7.
The following US Patents are relevant to the ARCHITECT i System or its
components. There are other such patents and patent applications in the
United States and worldwide.
5 468 646
5 565 570
7
5 543 524
5 669 819
5 545 739
5 783 699
ARCHITECT and Chemiflex are trademarks of Abbott Laboratories in
various jurisdictions.
All trademarks are property of their respective owners.
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
Produced by Biokit S.A., 08186 Barcelona, Spain for
Abbott
June 2011
8

Técnica de Medición

Transcription

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