Test ID: CHSBP    
Chronic Hepatitis Profile (Type B)

Hepatitis B Surface Antigen (HBsAg):

Specimens are first tested by the VITROS HBsAg assay. With modification to the assay manufacturer's instructions for use, specimens yielding S/CO > or =1.00 but < or =50.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/CO >50.0) do not require this confirmation. This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal anti-HBs antibody coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. 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 increases the level and duration of the light produced. The light signals are read by the VITROS ECi System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. J03798, version 1.0, Ortho-Clinical Diagnostics, Inc. Rochester, NY)

HBsAg Confirmation:

The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. J10583, version 1.0, Ortho-Clinical Diagnostics, Inc., Rochester, NY)

Hepatitis Be Antigen (HBeAg):

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 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)

Hepatitis Be Antibody (Anti-HBe):

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 HRP-labelled 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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