Wholesale Hepatitis B Antigen (HbsAg) Rapid Test Cassette
HbsAg Hepatitis B Rapid Test Strip (Whole Blood/Serum/Plasma)
SUMMARY
The general method of detecting infection with HbsAg is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with Western Blot. The One Step Test is a simple, visual qualitative test that detects antibodies in human Whole Blood/ serum /plasma. The test is based on immunochromatography and can give a result within 15 minutes.
INTENDED USE
The One Step Test is a Colloidal Gold enhanced, rapid Immunochromatoraphic Assay for the qualitative detection of antibodies to HBsAG in Human Whole Blood /Serum / Plasma. This test is a screening test and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for Healthcare Professional use only. Both the testing and the results of the testing are intended to be used by medical and legal professionals only, unless otherwise authorized by regulation in the country of use. The test should not be used without appropriate supervision.
REAGENTS AND MATERIALS SUPPLIED
Test device individually foil pouched with a desiccant
• Plastic dropper.
• Sample Diluent
• package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
Positive and negative controls (available as a separate item)
STORAGE & STABILITY
The test kits must be stored at 2-30℃in the sealed pouch and under dry conditions.
WARNINGS AND PRECAUTIONS
1) All positive results must be confirmed by an alternative method.
2) Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.
3) Devices used for testing should be autoclaved before disposal.
4) Do not use kit materials beyond their expiration dates.
5) Do not interchange reagents from different lots.
SAMPLE COLLECTION AND STORAGE
1) Collect Whole Blood /Serum / Plasma specimens following regular clinical laboratory procedures.
2) Storage: Whole Blood can not be frozen. A specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collecting. Avoid freezing and thawing the specimens more than 2-3 times before using. 0.1% of Sodium Azide can be added to specimen as a preservative without affecting the results of the assay.
ASSAY PROCEDURE
1) Using the enclosed plastic dropper for the sample, dispense 1 drop (10μl) of Whole Blood /Serum / Plasma to the circular sample well of the test card
2) Add 2 drops of Sample Diluent to the sample well, immediately after the specimen is added, from the dropper tip diluent vial (or all contents from the single test ampule).
3) Interpret test results at 15 minutes.
Notes:
1) Applying a sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to the sample well.
2) The positive results could appear as soon as one minute for a sample with high levels of HCV antibodies.
3) Do Not Interpret results after 20 minutes
READING THE TEST RESULTS
1) Positive: Both a purplish red test band and a purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
2) Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
3) Invalid result: There should always be a purplish red control band in the control region, regardless of the test result. If a control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples, as long as it is distinctly visible.
LIMITATION
1) Only clear, fresh, free flowing Whole Blood /Serum / Plasma can be used in this test.
2) Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position and checked for fluidity. Whole Blood can not be frozen.
3) Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the Specimen.
2) The positive results could appear as soon as one minute for a sample with high levels of HCV antibodies.
3) Do Not Interpret results after 20 minutes
READING THE TEST RESULTS
1) Positive: Both a purplish red test band and a purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
2) Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
3) Invalid result: There should always be a purplish red control band in the control region, regardless of the test result. If a control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples, as long as it is distinctly visible.
LIMITATION
1) Only clear, fresh, free flowing Whole Blood /Serum / Plasma can be used in this test.
2) Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position and checked for fluidity. Whole Blood can not be frozen.
3) Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the Specimen.
