INTENDED USE

Rapid HBsAb 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.

STORAGE

Store the test device at 4 to 30°C. Do Not Freeze.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic use only.

2. Do not use product beyond the expiration date.

3. Handle all specimens as potentially infectious.

REAGENTS AND MATERIALS PROVIDED

1. Rapid HBsAb Test

2. Instructions for use

3.Disposable transfer pipet

MATERIALS REQUIRED BUT NOT PROVIDED

1. Whole blood or plasma: Vacutainer tube, or other appropriate tube, containing heparin or EDTA as an anticoagulant

2. Serum: Vacutainer tube, or other appropriate tube, without anticoagulant

3. Timer or clock

QUALITY CONTROL

An internal procedural control is included in the test. A red-purple line will appears in the control region (C), which confirms sufficient specimen volume and correct operation for the test.

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.

REFERENCE

1. Krugman, S. and Giles, J.P. (1973). Viral hepatitis, type B (MS-2-Strain). Further observation on natural history and prevention . N. Engl. J. Med.

2. Krugman, S., Overby, L.R. et al. (1979). Viral hepatitis B. Studies on natural history and prevention re-examined. N. Engl. J. Med., 

3. Piet, M.P, Chin, S. et al. (1990). The use of tri (n-butyl) phosphate detergent mixtures to inactive hepatitis virus and human immunodeficiency virus in plasma and plasma's subsequent fractionation. Transfusion, 

4. Blumerg B.S., Suinick A.I., London W.T.. Hepatitis and leukemia: their relation to Australia antigen. Bull.N.Y.Acad.Med.. 

5. Boniolo A., Dovis M., Matteja R.. The use of enzyme-linked immunosorbent assay for screening hybridoma antibodies against hepatitis B surface antigen. J.Immunol.Meth

6. Caldwell C.W., Barpet J.T.. Enzyme immunoassay for hepatitis B and its comparison to other methods. Cli.Chim.Acta