REF:

C4118 (Strip)

C4119 (Cassette)

INTENDED USE：

HBV Surface Antigen Serum Test is a qualitative immunoassay that uses the double-antibody sandwich method todetect the hepatitis B virus surface antigen from serum/plasma specimen from patients who are suspected of HBV infection by a healthcare provider. Performance of the test is limited to professional use. The test kit cannot be used as the sole basis for treatment or other management decision.

For in vitro diagnostic use only.

SUMMARY：

Hepatitis B virus (HBV) is endemic throughout the world and is the major cause of liver disease. HBV is transmitted through direct contact with blood and body fluids. Common modes of transmission include needle puncture, direct contact with open wounds, sexual contact, and mother–neonate contact during birth.

The average incubation period for HBV infection is 6–8 weeks (range 1–6 months). Common clinical symptoms include malaise, fever, gastroenteritis, and icterus. Hepatitis B virus surface antigen (HBsAg) is a distinctive serological marker of HBV infection. HBsAg is the first antigen to appear following infection with hepatitis B virus and is generally detected 1–10 weeks before the onset of clinical symptoms. In patients with chronic HBV infection, HBsAg levels remain detectable for life. Prenatal HBsAg screening has been recommended so that new-borns from mothers obtain prophylactic treatment.