INTENDED USE

The HBeAb Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of HBeAb in serum or plasma.

SUMMARY

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Hepatitis B e antibody is a protein secreted by HBV-infected cells. The presence of antibody against hepatitis B viral e antigen is used as an indicator for early HBs antigenemia before the peak of viral replication and early convalescence when HBeAg has declined below detectable levels. It is also useful to confirm a seroconversion. The seroconversion from HBeAg positive to anti-Hbe positive indicates a reduced level of infectious virus because virus replication has decreased. The HBeAb Rapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBeAb in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBeAb in serum or plasma. This one step test is very sensitive and only takes about 10-20 minutes. Test results are read visually without any instrument.

PRINCIPLE

The HBeAb test is immunoassay based on the principle of competitive binding. During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with HBeAg on the test line region of the strip. During testing, if anti-HBe antibody present in the specimen, they will compete with particle coated anti-HBe antibody for limited amount of HBeAg on the membrane. No line will form in the test region. And a visible colored line will form in the test region if there is no anti-HBe antibody in the specimen because all the antibody coated particles will be captured by the antigen coated in the test line region. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.