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Hepatitis Be Antigen

Alternate Name: Hbeag_Atellica

SAL Code:

815

CPT:

87350

Loinc:

13954-3

Turn Around Time:

24 Hours

Setup:

Mon - Sun

Units:

Index

Department:

Hepatitis B

Methodology:

The Atellica IM HBeAg assay is an antibody sandwich (antibodies bridged by an antigen present in a sample) 2-step immunoassay. The Solid Phase contains a preformed complex of streptavidin coated microparticles and biotinylated anti-HBe monoclonal antibody and is used to capture
HBeAg from the patient sample. The Lite Reagent contains anti-HBe monoclonal antibody labeled with acridinium ester and is used to detect HBeAg in the sample. Solid Phase is added to the sample, followed by Lite Reagent. Antibody-antigen complexes form if HBeAg is present in the sample. A direct relationship exists between the amount of HBeAg activity present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive or nonreactive is determined according to the Index Value established with the calibrators. Refer to Interpretation of Results.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Fridge:

2 - 8 C up to 7 days

Additional Information:

The Atellica® IM Hepatitis B e Antigen (HBeAg) assay is an in vitro diagnostic immunoassay for the qualitative determination of the hepatitis Be antigen (HBeAg) in human serum and plasma (potassium EDTA, lithium heparin, and sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the Atellica® CI Analyzer. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis B virus.

Test Limitations:

- The Atellica IM HBeAg assay is limited to the detection of hepatitis B e antigen in human serum or plasma (potassium EDTA, lithium heparin, and sodium heparin).
- The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.
- A nonreactive test result does not guarantee that HBeAg is not present. HBV mutants lacking the ability to produce HBeAg have been reported. These may occur as ‘escape’ mutants in the presence of anti-HBe and such patients may be infectious.
- A reactive HBeAg result does not exclude co-infection by another hepatitis virus.
- The performance of the assay has not been established with cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid.
- The performance of the assay has not been established for populations of
immunocompromised or immunosuppressed patients.
-Assay performance characteristics have not been established for the Atellica IM HBeAg assay used in conjunction with other manufacturers' assays for specific HBV serologic markers. Laboratories are responsible for establishing their own performance characteristics.
- Results from patients taking biotin supplements or receiving high-dose biotin therapy should be interpreted with caution due to possible interference with this test.
- Patient samples may contain heterophilic antibodies that could react in
immunoassays to give 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: