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Hepatitis Be Antibody

Alternate Name: aHBe2_Atellica

SAL Code:

816

CPT:

86707

Loinc:

13953-5

Turn Around Time:

24 hours

Setup:

Mon - Sun

Units:

Index

Department:

Hepatitis B

Methodology:

The Atellica IM aHBe2 assay is a fully automated 2-step competitive immunoassay using chemiluminescent technology. The Ancillary Well Reagent contains recombinant HBeAg. The Solid Phase contains microparticles coated with aHBe monoclonal antibody. The Lite Reagent contains aHBe monoclonal antibody labeled with acridinium ester. The sample is incubated with the Ancillary Well Reagent. During the incubation period, aHBe in the sample binds with recombinant HBeAg. The Solid Phase and Lite Reagent are added next and bind any recombinant HBeAg not already bound by sample. After a wash step, acid and base are dispensed to initiate the chemiluminescent reaction. An inverse relationship exists between the amount of aHBe activity present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive or non-reactive is determined according to a cut-off of 1.00 Index established with the calibrators.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Ambient:

72 hours

Stable Fridge:

8 days at 2-8 C

Additional Information:

The Atellica® IM Anti-HBe2 (aHBe2) assay is an in vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2–21 years old) and adult serum, EDTA plasma, or lithium heparin plasma using the Atellica® IM Analyzer. Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with signs or symptoms of hepatitis B infection, or with risk factors for HBV infection, or with known HBV infection. Results of the assay, in conjunction with other diagnostic information, may be used to aid in determining HBV seroconversion. This assay is not intended for screening donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Test Limitations:

- Assay performance characteristics have not been established for the Atellica IM aHBe2 assay used in conjunction with other manufacturers' assays for specific HBV serological markers. Laboratories are responsible for establishing their own performance characteristics.
- The performance of the assay has not been established with cadaver specimens, heat inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid.
- Results for a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay used. Values obtained
with different assay methods cannot be used interchangeably.
- The Atellica IM aHBe2 assay is limited to the detection of aHBe in human serum, EDTA plasma, or lithium heparin plasma.
- A nonreactive test result does not exclude the possibility of exposure to or infection with HBV. Human aHBe may be undetectable in some stages of the infection and in some clinical conditions.
- 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.

Test Information:

Components: