INTENDED USE
HBsAb Rapid Test is a chromatographic immunoassay for qualitative detection of the surface antibody of hepatitis B virus (Anti-HBs) in human whole blood samples. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products.
PRINCIPLE
HBsAb Rapid Test employs chromatographic lateral flow device. Colloidal gold conjugated surface antigen reactive to anti-HBs (sAg-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate. If present, anti-HBs will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by HBsAg immobilized there and a visible red line appears. If there is no anti-HBs in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-HBs antibody and aggregating in a red line, which indicates the validity of the test
STORAGE
Store the test kits at temperature 4-30°C，in the sealed pouch for the duration of the shelf life (24 months).
ASSAY PROCEDURE
1. Bring all materials and specimens to room temperature.
2. Remove the test cassette from the sealed foil pouch.
3. Label the test cassette with specimen identity by writing the ID on the top label of the strip.
4. Place the test cassette on a flat horizontal surface.
5. Using the transfer pipette to draw up the sample.
6. Hold the transfer pipette in a vertical position over the sample pad and dispense 2-3 drops (80-120 l) of sample onto the sample pad.
7. Read the result at 20 minutes after adding the sample.
Note: Some positive samples may show positive results before 20 minutes. Results after 30 minutes may not be accurate.
INTERPRETATION OF RESULTS
Positive: Two colored bands appear within 20 minutes. One colored band appears in the Control Zone (C) and another colored band appears in the Test Zone (T). The test result is positive and valid. No matter how faint the colored band appears in the Test Zone (T), the test result should be considered as positive result.
Negative: One colored bands appears in the Control Zone (C) within 20 minutes. No colored band appears in the Test Zone (T). The test result is negative and valid.
Invalid result: No colored band appears in the Control Zone (C) within 20 minutes. The test result is invalid. Repeat the test with a new test device.
