Test ID: HEAG    
Hepatitis Be Antigen and Hepatitis Be Antibody, Serum

HBe Antigen (HBeAg) Assay:

This test is performed using the FDA-approved VITROS HBeAg Reagent Pack and the Immunodiagnostic Product HBeAg Calibrator on the VITROS ECi/ECiQ Immunodiagnostic System based on chemiluminescence immunoassay principle. An immunometric technique is used. This involves the simultaneous reaction of HBeAg in the sample with biotinylated mouse monoclonal HBeAg antibody and horseradish peroxidase (HRP)-labeled mouse monoclonal HBeAg antibody in the conjugate. The immune complex is captured by streptavidin on the wells, unbound materials are removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBeAg present in the sample. (Package insert: VITROS Immunodiagnostic Product HBeAg Reagent Pack, No. GEM1222, version 1.0; Ortho-Clinical Diagnostics, Rochester, NY 14626-5101, 5/24/2011)

HBe Antibody (Anti-HBe) Assay:

This test is performed using the FDA-approved VITROS Anti-HBe Reagent Pack and the VITROS Anti-HBe Calibrator on the VITROS ECi/ECiQ Immunodiagnostic Systems based on chemiluminescence immunoassay principle. A competitive technique is used which involves pre-incubation of anti-HBe IgG in the sample with a fixed weight of HBeAg in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HBe IgG and horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBe IgG. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of anti-HBe IgG present in the sample (Package insert: VITROS Immunodiagnostic Product Anti-HBe Reagent Pack, No. GEM1223, version 1.0; Ortho-Clinical Diagnostics, Rochester, NY 14626-5101, 7/20/2011)

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