BIPL HBsAg Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum/plasma at a level equal to or higher than 0.5 ng/mL. It is intended to be used as a screening test and as an aid in the diagnosis of infection with hepatitis B virus (HBV). Any reactive specimen with the BIPL HBsAg Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
BIPL HBsAg Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of:
1) a burgundy colored conjugate pad containing mouse anti-HBsAg antibody conjugated with colloidal gold (HBsAg Ab conjugates) and a control antibody conjugated with colloidal gold,
2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with non-conjugated HBsAg antibody, and the C line is pre-coated with a control line antibody.