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Hepatitis B Core Antibody Total

Alternate Name: HBcT2_Atellica

SAL Code:

812

CPT:

86704

Loinc:

13952-7

Turn Around Time:

72 hours

Setup:

Mon - Sun

Units:

Index

Department:

Hepatitis B

Methodology:

The Atellica IM HBcT2 assay is a 2-wash antigen sandwich immunoassay in which antigens are bridged by antibody present in the patient sample. The Solid Phase contains a preformed complex of streptavidin-coated microparticles and biotinylated recombinant HBc antigen, and is used to capture anti-HBc in the patient sample. A result of reactive or nonreactive is
determined according to the Index Value established with the calibrators.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Alternate Sample Info:

Plasma, EDTA Lavender

Temperature

Period

Stable Fridge:

7 days at 2-8 C

Clinical Info:

This assay is an in vitro diagnostic immunoassay for use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human pediatric (2–21 years old) and adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica® IM Analyzer. This assay can be used as an aid in the diagnosis of acute or chronic hepatitis B virus (HBV) infection, and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers, for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

Test Limitations:

- The Atellica IM HBcT2 assay is limited to the detection of total antibodies to hepatitis B core antigen in human serum or plasma. Assays for the detection of anti-HBc may not identify all patient samples that contain hepatitis B virus.
- Patient samples may contain heterophilic antibodies that could react in immunoassays and cause falsely elevated or depressed results. This assay is designed to minimize interference from heterophilic antibodies. Additional information may be required for diagnosis.

Test Information:

Components: