i PSA TM Boditech Med Inc.

i-CHROMATM PSA
Boditech Med Inc.
i-CHROMATM PSA
biotin labeled BSA, gelatin as a stabilizer, and sodium azide as a
preservative in PBS.
ImmunoAssay for Quantitative Measurement of PSA in
WARNINGS AND PRECAUTIONS
Human Whole blood / Serum / Plasma with the i-
• IVD For In Vitro Diagnostic Use.
CHROMATM Reader system
• Carefully follow the instructions and procedures described in this
insert. REF Catalog No. i-CHROMATM PSA-25
• Don’t use the Test Device if its lot number shown on the pouch
does not agree with that on the ID chip.
INTENDED USE
i-CHROMA PSA along with i-CHROMATM Reader is a test for
the total PSA (tPSA) concentration in the Whole
blood/serum/plasma/whole
blood1
utilizing
fluorescence
immunoassay. The test is used as an aid in prescreening and
therapeutic evaluation of prostate cancer patients.
• i-CHROMATM PSA works only with i-CHROMATM Reader.
Tests should be applied by trained personnel working in facilities
where the sample(s) is taken by qualified individuals.
•
LOT Neither interchange materials from different
product lots nor use beyond the expiration date. The use
of medical device beyond expiration date may affect the
test result.
•
i-CHROMATM PSA should remain in its original sealed
pouch until ready to use. Do not use the Test Device if
the pouch should be damaged or the seal broken. Discard
after single use.
INTRODUCTION
Prostate specific antigen (PSA) is a neutral serine protease with
chymotrypsin-like activity and composed of a single polypeptide
chain of 237 amino acids. It is an intracellular glycoprotein
containing 7-8% carbohydrate as a single N-linked oligosaccharide
side chain, and has a molecular weight of approximately 33 KDa.
PSA is synthesized by the glandular epithelium of the prostate and
present in benign hyperplastic and malignant prostatic tissue, in
metastatic prostatic carcinoma, in prostatic fluid, and seminal
plasma. Low levels of PSA are found in the blood of normal male
as a result of leakage of the antigen from the prostate gland into
circulation. The elevated levels of PSA in the blood are associated
with prostatic pathology, including prostatitis, benign prostatic
hyperplasia (BPH), and prostate cancer.
i-CHROMATM PSA quantitatively measures the total PSA
concentration in the human whole blood/serum/plasma.
• i-CHROMATM PSA and the reader should be used away from
vibration and magnetic field. During normal usage, iCHROMATM Reader may produce minute vibration, which
should be regarded as normal.
•
Use separate clean pipette tips and sample vials for
different specimens. Pipette tips and sample vials should
be used for one specimen only. Discard after single use.
•
Urine specimens, used test devices, pipette tips and
sample vials are potentially infectious. Proper laboratory
safety techniques, handling and disposal methods should
be followed in accordance with standard procedures and
relevant regulations observed by microbiological hazard
materials.
PRINCIPLE
The test uses the sandwich immune-detection method, such that the
detector antibody in the buffer binds to the PSA/PSA complex in
the serum or the plasma sample and antigen-antibody complexes
are captured to the antibody that has been immobilized on the test
strip as the sample mixture migrates through the nitrocelluose
matrix. The more PSA antigen in the blood, the more antigenantibody complexes accumulates on the test strip. The signal
intensity of fluorescence on the detector antibody reflects the
amount of the antigen captured and is processed by i-CHROMATM
Reader to present the PSA concentration in the specimen. The
working range of i-CHROMATM PSA is 0.1-100 ng/ml(in case of
whole blood, 0.5-100 ng/ml)
• i-CHROMA PSA should not be used as absolute evidence for
the prostate cancer. The results should be interpreted by a
physician along with clinical findings and other laboratory test
results.
• The test will be applied on a routine basis and not in emergency
situations.
• Do not smoke, eat, or drink in areas in which specimens or kit
reagents are handled.
STORAGE AND STABILITY
* Reference Value: 4 ng/mL

COMPOSITION OF REAGENTS
i-CHROMATM PSA consists of the Test Device, ID Chip, and
Detection Buffer. The Test Device is individually sealed with a
desiccant in an aluminum pouch, and the Detection Buffer is predispensed individually in a tube and a the bottle containing these
tubes is delivered separately in a Styrofoam box filled with ice
packs.
 The Test Device contains a test strip on which the mouse antiPSA antibody and streptavidin have been immobilized on the
test and on the control line, respectively.
 The Detection Buffer, pre-dispensed in a tube, contains
fluorescence-labeled anti-human PSA antibody, fluorescence-
Rev. 09_ 101217_S
Store the Detection Buffer in a refrigerator at 2° - 8°C.
The Detection Buffer is stable up to 20 months if stored
according to this guide line.
 Once removed from the refrigerator, allow 30 minutes for the
Detection Buffer to reach the room temperature before testing.

Store i-CHROMATM PSA at 4°-30°C in its sealed pouch.
i-CHROMATM PSA is stable for 20 months (while in the
sealed pouch) if stored at 4°-30°C.
 If stored in a refrigerator, allow a minimum of 30 minutes for the
Test Device and the Detection Buffer to reach the room
temperature with the test device remaining in the sealed pouch.
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Boditech Med Inc.
 Do not remove the test device from the pouch until ready to use.
The test device should be used within 3 minutes after opening the
pouch.
 The storage and shipping of Test Kit should be complied as
indicated in this insert. However, it is remotely possible that
some part of the Test Kit may be affected by the stability
problems.
SAMPLE COLLECTION AND PREPARATION
The test can be performed with either the whole blood or serum or
the plasma.
 For the serum sample, collect the blood in a tube without an
anticoagulant and allow it to clot. Remove the serum from the
clot as soon as possible to avoid hemolysis.
 For the plasma sample, collect the blood in a tube treated with
EDTA. Anticoagulants other than EDTA have not been evaluated.
If testing cannot be conducted within an hour after preparation of
specimen, the serum/plasma should be stored at -20o C.
 The specimen must be at room temperature and be homogeneous
for testing. Frozen specimens must be completely defrosted,
thoroughly mixed and brought to the room temperature prior to
testing. If specimens are to be shipped, they should be packed in
compliance with standing local regulations.
 It is recommended to avoid using severely hemolyzed specimens
whenever possible. If a specimen appears to be severely
hemolyzed, looking translucent, another specimen should be
obtained.
MATERIALS PROVIDED
Boditech Med Incorporated i-CHROMATM PSA
Catalog
REF Catalog No. i-CHROMATM PSA -25
7.
or more.
Take 75 µL of the sample mixture and load it onto the
sample well of the Test Device.
Load the Test Device into i-CHROMATM Reader. Make sure
direction of Test Device and push the device back all the way.
Instrument will automatically scan the Test Device after 15min.
Read the results on the display screen of i-CHROMATM Reader.
8.
 Refer to i-CHROMATM Reader Operation Manual for the
complete instructions on use of the Test.
REF Catalog No. FR- 203
RESULT
i-CHROMATM
Reader
calculates
PSA
concentration
automatically and displays the result on the LCD in units of
ng/mL. For further information, refer to the Operation Manual for
i-CHROMATM Reader.
Quality Control
 A quality control test using commercially available controls
should be performed as a part of good testing practice, to
confirm the expected QC results, to confirm the validity of the
assay and to assure the accuracy of patient results. Controls from
Abbott-AxSYM are recommended.
 A quality control test should be performed at regular intervals,
and before using a new kit with patient specimens. QC
specimens should also be run whenever there arises any
questions concerning the validity of results obtained. Upon
confirmation of the expected results, the test device is ready for
use with patient specimens. Control standards are not provided
with this test kit. For information about obtaining the controls,
contact Boditech Med Incorporated’s Technical Services for
assistance.
Procedure Control
 Each i-CHROMATM PSA Test Device contains internal control
that satisfies routine quality control requirements. This internal
control is performed each time a patient sample is tested. This
control indicates that the test device was inserted and read
properly by i-CHROMATM Reader. An invalid result from the
internal control causes an error message on i-CHROMA Reader,
indicating the need for intervention from the user.
Box contains:
Test Devices
Detection Buffer
ID Chip
Insert
6.
x 25
x 25
x1
x1
MATERIALS REQUIRED BUT NOT PROVIDED
i-CHROMATM Reader REF Catalog No. RF-203
Thermal Printer (optimal)
Transfer pipette (75µL, 30 µL volume)
LIMITATIONS OF THE PROCEDURE
• Results of i-CHROMATM PSA should be evaluated with all
clinical and laboratory data available. If PSA results should not
agree with the clinical evaluation, additional tests should be
performed.
PROCEDURE
•Schematic of the Test Device
window
1.
2.
3.
4.
5.
sample well
Set a Test Device on a dust-free clean place.
Check/insert ID Chip onto the instrument. Make sure that the
Test Device lot # agrees with ID Chip #.
Take one tube of Detection Buffer from the refrigerator and
leave it at room temperature for 30 min or longer.
Draw 75ul of serum / plasma with a transfer pipette and add
it to the tube containing the Detection Buffer.
Close the Detection Buffer lid and mix the specimen
thoroughly with Detection Buffer by shaking the tube 10 times
Rev. 09_ 101217_S
• The false positive results include cross-reactions with some
components of the serum from individual to antibodies; and nonspecific adhesion of some components in human blood that have
similar epitopes to capture and detector antibodies. In the case of
false negative results, the most common factors are: nonresponsiveness of the antigen to the antibodies by certain
unknown components masking epitopes, such that antigen cannot
be seen by the antibodies; instability of PSA antigen, resulting in
degradation with time and, or temperature, such that they become
no longer recognizable by antibodies; and other degraded test
components. The effectiveness of the test is highly dependent on
storage of kits and sample specimens. It is of critical importance
to store them at optimal conditions.
• Plasma using anticoagulants (e.g. heparin or citrate) other than
EDTA has not been evaluated in i-CHROMATM PSA and thus
should not be used.
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Boditech Med Inc.
2.
Analytical Sensitivity
i-CHROMA PSA was evaluated for the limit of detection.
Three different lots of Test Devices were evaluated with 10
runs of each lot. The minimum detection limit was defined as
+3SD over result from null specimens. The limit of PSA in iCHROMA PSA was determined to be 0.08ng/ml.
Specificity
Other bio-molecules, such as Hb, CEA, AFP, ALP, CRP,
Troponin I, CK-MB- Myoglobin, and Albumin were added to
test specimen with much higher level than their physiological
level in normal blood. There was no significant interference
with the PSA measurement, nor was their any significant assay
cross-reactivity with those bio-molecules tested.
3. Precision
Intra-assay precision
Serum/Plasma
Sample
Mean
SD
CV
(ng/ml)
0.1
0.11
0.01
7.22
0.5
0.50
0.02
4.12
1
1.04
0.06
5.80
2
2.07
0.06
3.01
4
3.99
0.09
2.36
25
24.72
0.81
3.29
Inter-assay precision
Serum/Plasma
Sample
Mean
SD
CV
(ng/ml)
0.1
0.10
0.01
5.48
0.5
0.50
0.02
3.30
1
1.04
0.06
6.06
2
2.08
0.04
2.05
4
3.95
0.12
3.05
25
26.14
0.81
3.11
Whole blood
Mean
SD
CV
0.06
0.53
1.00
2.03
4.01
26.14
0.05
0.08
0.12
0.07
0.15
0.84
81.99
15.15
11.60
3.66
3.66
3.22
Mean
SD
CV
0.06
0.53
1.02
2.02
4.04
26.14
0.05
0.10
0.11
0.08
0.17
1.25
75.09
18.18
10.48
4.12
4.22
4.77
50
i-Chroma , serum [ng/ml]
N = 100
R = 0.98857
30
20
10
0
0
10
20
30
i-Chroma , whole blood[ng/ml]
Rev. 09_ 101217_S
40
50
N = 100
R = 0.98732
40
30
20
10
0
0
10
20
30
40
50
PSA serum [ng/ml]
The correlation performed on whole blood vs. serum and
Serum vs. Plasma (EDTA) were R=0.989 and 0.987,
respectively.
5. Comparability
Total PSA concentrations of 150 clinical specimens were
quantified with i-CHROMATM PSA and with Abbott
AXSYM automatic analyzer according to the established
standard test procedure. Test results were compared and their
compatibility was investigated with the linear regression and
the correlation coefficient (R). The linear regression and the
correlation coefficient were Y=0.98X-0.34 and R=0.99
respectively.
50
40
Whole blood
4. Precision Correlation of Whole Blood vs. Serum vs. Plasma
40
50
PSA plasma(EDTA) [ng/ml]
Performance Characteristics
1.
60
BTF-PSA[ng/ml]
• Other factors may interfere with the performance of i-CHROMA
TM
PSA and may cause erroneous results. These include
technical or procedural errors, as well as additional substances in
blood specimens.
Y = 0.982X-0.33867
SD = 1.46
R = 0.99352
30
20
10
0
0
10
20
30
40
50
Abbott AXSYM[ng/ml]
REFERENCES
1. Brooks DE, Devine DV, Harris PC, et al. RAMP(TM): A rapid,
quantitative whole blood immunochromatographic platform for point-ofcare testing. Clin. Chem. 1999; 45:1676-1678.
2. Jung K, Elgeti U, Lein M, et al. Ratio of Free or Complexed Prostatespecific Antigen to Total PSA: Which Ratio Improves Differentiation
between Benign Prostatic Hyperplasia and Prostate Cancer? Clin. Chem.
2000; 46(1): 55-62.
3. Allard WJ, Zhou Z, Yueng KK. Novel immunoassay for the measurement
of complexed prostate-specific antigen in serum. Clin. Chem. 1998; 44(6):
1216-1223.
4. Junker R, Brandt B, Zechel C, and Assmann G. Comparison of prostatespecific antigen (PSA) measured by four combinations of free PSA and
total PSA assays. Clin. Chem. 1997; 43(9): 1588-1594.
5. Cheli CD, Marcus M, Levine J, et al. Variation on the Quantitation of
Prostate-specific Antigen in Reference Material: Differences in Commercial
Immunoassays. Clin. Chem. 1998; 44:1551-1553.
6. Kim BC, Jeong JH, Jeong DS, Choi EY, Kim JH, Nahm, KB. Simplified
laser fluorescence scanner for proteomics studies and early cancer
diagnosis. SPIE Proceedings 2002;4916:103-108.
7. Woolf SH, Rothemich SF. SCREENING FOR PROSTATE CANCER:
The Roles of Science, Policy, and Opinion in determining what is best for
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i-CHROMATM PSA
Boditech Med Inc.
Patients. Annu. Rev. Med. 1999; 50:207-521.
8. Wan XS, Xu YA, Ware JH, and Kennedy AR. Three immunoassays based
on monoclonal antibodies specific for prostate specific antigen (PSA),
alpha-1-antichymotrypsin (ACT), and the PSA-ACT complex. Prostate
2003; 56:131-141.
9. Jung K, Brux B, Lein M, et al. Molecular Forms of Prostate-specific
Antigen in Malignant and Benign Prostatic Tissue: Biochemical and
Diagnostic Implications. Clin. Chem. 2000; 46(1): 47-54.
10. Frankel S, Smith GD, Donovan J, Neal D. Screening for prostate cancer.
Lancet 2003; 361:1122-1128.
11. Jung K, Klinggr P, Brux B, et al. Preanalytical Determinants of Total and
Free Prostate-Specific Antigen and Their Ratio: Blood Collection and
Storage Conditions. Clin. Chem. 1998; 44:685-688.
Bodtech Med Inc.’s express and implied warranties (including
implied warranties of merchantability and fitness) are conditional
upon observance of Boditech Med’s published directions with
respect to the use of Boditech Med’s products.
For Technical Assistance call
Boditech Med Inc.’s Technical Services at
Tel: +82 (33) 243-1400
E-mail: sales@boditech.co.kr
Boditech Med Incorporated
1144-2 Geoduri Dongnaemyeon,
Chuncheon, Gangwondo 200-883
Republic of Korea
Tel: +82 (33) 243-1400
Fax: +82 (33) 243-9373 www.boditech.co.kr
EU Representative: Jai Jun Choung, Ph.D.
Eu Biotech Development Ltd.
81 Oxford Street, LONDON, W1D 2EU
United Kingdom
Tel: +44 207 903 5441
Fax: +44 207 903 5333
E-Mail: jjchoung@eubio.co.uk
i-CHROMATM is registered trademarks of Boditech Med
Incorporated.
Revision No: 09
Date of last revision: December 17, 2010.
0123
Rev. 09_ 101217_S
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