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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.
Rapid HBsAb 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
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
Contact Person: Ms. Anna Lee