HBeAg Rapid Test

Description

Intended Use

HBeAg Rapid Test (Serum/Plasma) is an in vitro immunoassay for the qualitative detection of Hepatitis Be Antigen in serum or plasma. HBeAg Rapid Test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of HBeAg in serum or plasma.

Introduction

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 or Hepatitis C virus. Hepatitis B virus (HBV) chronically infects 300 million people worldwide, and increases their risk to develop hepatocellular carcinoma by a hundred fold1.

Hepatitis B e antigen (HBeAg) is a viral protein secreted by HBV-infected cells. HBeAg was identified as a marker for patients at high risk for transmission of the disease2. 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 Rapid 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 test is very sensitive and only takes about 10-20 minutes. Test results are read visually without any instrument.