One Step HBV Multi-5 Test >Weak Positive: Colored band appearing in control region(c)

>Negative:Two colored bands appearing in both control (c) and test Region(T).
INTRODUCTION
>Invalid: No band appearing in the
The One Step Cassette Style HBV Test is a rapid test based on the principle of
immunoassay combined with conjugated colloid gold technology. The HBV Test is control region(c) is an indicator of
a diagnostic device to detect the 5 markers associated with Hepatitis B infection. procedural error and /or the test reagent
SPECIMEN COLLECTION has been deteriorated.
For serum, collect blood into a container without anticoagulant. Allow the blood to Specimen should be re-tested again. If
clot and separate the serum from the clot. Use the serum for testing. problem persists, stop using products
from this lot.
If the specimen cannot be tested on the day of collection, store the serum
specimen in a refrigerator or freezer.Stir and bring the specimens to room STORAGE AND STABILITY
temperature before testing. Do not freeze and thaw the specimen repeatedly. The test kit can be stored at temperatures from 2 to 30 in the sealed pouch
up to date of expiration .The test kit should be kept away from direct sunlight and
TEST PROCEDURE
moisture..Do not freeze the test kit.
1 Remove be test kit from the pouch and place it horizontally on the desk. Use the
test device as soon as possible. PRECAUTION
2. Pipette 3 to 4 drops of serum in each sample well, read results after 15 minutes. 1. For in vitro diagnostic use only.
It is important that the background is clear before the results are read. 2. Do not use test kit beyond the expiry date.
3. The test device should not be reused.
4. Urine specimens may be infectious; insure proper handling and dispose of all
used reaction devices into a biohazard container.
PERFORMANCE CHARACTERISTICS
1. Diagnostic Sensitivity and Specificity
The diagnostic sensitivity and specificity of HBV Multi-5 Test were studied using
363 HBsAg /358 HBsAb /355 HBeAg /359 HBeAb /357 HBcAb positive samples
and comparison with a CE licensed commercial HBV Test.
Comparison Comparison Total
Note: For weak positive, read results after 25 minutes but no longer than Diagnostics (+) Diagnostics (-)
30 minutes (Diagram above) HBsAg Test (+) 365 0 365
HBsAg Test (-) 4 644 648
INTERPRETATION OF RESULTS Total 369 644 1013
For HBsAg, HBsAb, HBeAg (Diagram 2)
The HBsAg positive coincidence rate is 98.9%; negative coincidence rate is 100%;
Ø Positive :Colored bands appearing in both
total coincidence rate is 99.6%.
Control(c) and test Region(T)
Ø Negative: Only one colored band appears in
Comparison Comparison Total
Control Region(c).
Diagnostics (+) Diagnostics (-)
Ø Invalid: No band appearing in the control region(c)
HBsAb Test (+) 356 0 356
is an indicator of procedural error and /or the test
reagent has been deteriorated. Specimen should be re-tested again. If HBsAb Test (-) 6 646 652
problem persists, stop using products from this lot. Total 362 646 1008
The HBsAb positive coincidence rate is 98.8%; negative coincidence rate is 100%;
For HBeAb, HBcAb (Diagmrn 3) total coincidence rate is 99.4%.
>Positive: A distinct colored band appearing in the Control Region(C). Comparison Comparison Total
 Diagnostics (+) Diagnostics (-) Benzoylecgonine 20 mg/dl Hemoglobin 1,000 mg/dl
HBeAg Test (+) 354 0 354 Atropine 20 mg/dl
HBeAg Test (-) 9 645 654 5. Reproducibility
Total 363 645 1008 The precision was determined by replicate assays of both positive and negative
The HBeAg positive coincidence rate is 97.5%; negative coincidence rate is 100%; samples with devices from three different production lots. The resultant data
total coincidence rate is 99.1%. indicated no appreciable difference between lot variation when testing both
Comparison Comparison Total positive and negative samples across three different lots.
Diagnostics (+) Diagnostics (-) REFERENCES
HBeAb Test (+) 353 0 353 1. Wolters G, Kuijpers L, Kacaki J, Schuurs AHWM. Solid-phase
HBeAb Test (-) 10 646 656 enzyme-immunoassaf for detection of hepatitis B surface antigen. J Clin
Total 363 646 1009 Pathol (1976), 29 (10): 873-879.
The HBeAb positive coincidence rate is 97.2%; negative coincidence rate is 100%; 2. David GS, Present W, Martinis J, Wang R, Bartholomew R, Desmond W,
total coincidence rate is 99.0%. Sevier ED. Monoclonal antibodies in the detection of hepatitis infecrion. Med
Comparison Comparison Total Lab Sci (1981) 38: 341-348.
Diagnostics (+) Diagnostics (-) 3. De Meyer S, Gong ZJ, Suwandhi W, van Pelt J, Soumillion A, Yap Sh. Organ
HBcAb Test (+) 353 0 353 and species specificity of hepatitis B virus (HBV) infection: a review of
HBcAb Test (-) 9 645 654 literature with a special reference to preferential attachment of HBV to human
Total 362 645 1007 hepatocytes. J Viral Hepat (1997), 4:145-153.
The HBcAb positive coincidence rate is 97.5%; negative coincidence rate is 100%; 4. Cho EW, Park JH, Yoo OJ, Kim KL. Translocation and accumulation of
total coincidence rate is 99.1%. exogeneous hepatitis B virus pre surface proteins in the cell nucleus. J Cell
2. Analytic Sensitivity Sci (2001). 144 (Pt6): 1115-1123.
One-Step HBV Multi-5 Test detects HBsAg / HBsAb/ HBeAg / HBeAb/ HBcAb in 5. Cooper A, Paran N, Shaul Y. The earliest steps in hepatitis B virus infection.
Human serum of 2.0ng/ml /20mIU/ml /2.0IU/ml /400mIU/ml /1000mIU/ml. Biochim Biophys Acta (2003). 1614: 89-96.
3. Analytic Specificity
The effect of seromarkers associated with unrelated medical conditions on the INDEX OF SYMBOLS
specificity of the One-Step HBV Multi-5 Test was assessed using a panel of Do not reuse Batch code
specimens. The seromarkers studied were: HAV+, HIV+, HCV+, HEV+, Syphilis+,
RF+, H.pylori+, CMV+, Rubella+, TOXO+. The test panel was comprised of 160 In vitro diagnostic medical
Use by
HBV Multi-5 Test negative specimens. Of the 160 specimens, 60 contained one or device
more of the above seromarkers while 100 were health negative specimens. The Contains sufficient for <n>
Temperature limitation
results demonstrated that HBV Multi-5 Test kits have no cross-reactivity with these tests
specimens. Caution Catalog number
4. Interference
The following substances and conditions were found not to interfere with the test. Manufacturer Consult instructions for use
List of potentially interfering chemical analytes and concentrations tested are as
follows: Authorised representative in
CE Mark
the European community
Acetaminophen 20 mg/dl Cannabinol 10 mg/dl
Acetylsalicylic acid 20 mg/dl Ethanol 1%
Ascorbic acid 20 mg/dl Methanol 1%
Caffeine 20 mg/dl Heparin 1%
Gentesic acid 20 mg/dl Citrate 3.2%
Phenylpropanolamine 20 mg/dl Albumin 2,000 mg/dl
Salicylic acid 20 mg/dl Glucose 2,000 mg/dl
EDTA 80 mg/dl Bilirubin 1,000 mg/dl