INTENDED USE

The HBeAg Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of HBeAg 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, Hepatitis B virus (HBV) or Hepatitis C virus. Hepatitis B e antigen is a viral protein secreted by HBV-infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier. If this test is negative, but a person is known to be HBsAg positive, then it indicates low levels of virus in the blood or an “integrated phase” of HBV in which the virus is integrated into the host’s DNA. This test is often used to monitor the effectiveness of some HBV therapies, whose goal is to convert an actively replicating state to “e-antigen negative” state.
The HBeAg One Step Hepatitis B e Antigen Test Device (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBeAg in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBeAg in serum or plasma.
This one step test is very sensitive and only takes about 10-20minutes. Test results are read visually without any instrument.

PRINCIPLE

The HBeAg test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of HBeAg in serum or plasma. The membrane is pre-coated with anti-HBeAg antibodies on the test line region of the strip. Du ring testing, the serum or plasma specimen reacts with the particle coated with anti-HBeAg antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBeAg antibodies on the membrane and generate a colored line.
The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. 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.