MicroELISA

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Enzyme ImmunoAssay (ELISA) for the determination of Hepatitis B Virus "e" Antigen and Antibody in human plasma and sera. The kit is intended for the follow-up of acute infection and of chronic patients under therapy. For “in vitro” diagnostic use only.

Hepatitis B “e” Antigen or HBeAg is known to be intimately associated with Hepatitis B Virus or HBV replication and the presence of infectious Dane particles in the blood.

Recently, it has been found that HBeAg is a product of proteolytic degradation of Hepatitis B core Antigen or HBcAg, occurring in hepatocites, whose expression is under the control of the precore region of HBV genome. If HBeAg is considered a specific marker of infectivity, the presence of anti HBeAg antibodies in blood is recognised to be a clinical sign of recovery from infection to convalescence.

The determination of these two analytes in samples from HBV patients has become important for the classification of the phase of illness and as a prognostic value in the follow up of infected patients.

HBeAg:

HBeAg, if present in the sample, is captured by a specific monoclonal antibody, in the 1st incubation. In the 2nd incubation, after washing, a tracer, composed of a mix of two specific anti HBeAg monoclonal antibodies, labeled with peroxidase (HRP), is added to the microplate and binds to the captured HBeAg. The concentration of the bound enzyme on the solid phase is proportional to the amount of HBeAg in the sample and its activity is detected by adding the substrate TMB in the 3^rd incubation. The presence of HBeAg in the sample is determined by means of a cut-off value that allows for the semiquantitative detection of the antigen.

HBeAb:

Anti HBeAg antibodies, if present in the sample, compete with a recombinant HBeAg preparation for a fixed amount of an anti HBeAg antibody, coated on the microplate wells. The competitive assay is carried out in two incubations, the first with the sample and recHBeAg, and the second with a tracer, composed of two anti HBeAg monoclonal antibodies, labeled with peroxidase (HRP). The concentration of the bound enzyme on the solid phase becomes inversely proportional to the amount of anti HBeAg antibodies in the sample and its activity is detected by adding the substrate TMB in the third incubation. The concentration of HBeAg specific antibodies in the sample is determined by means of a cut-off value that allows for the semi quantitative detection of anti HBeAg antibodies.

The kit contains reagents for 96 tests (code 071004).