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Hepatitis B Surface Antigen

Alternate Name: HBsII_Atellica

SAL Code:

810

CPT:

87340

Loinc:

5196-1

Turn Around Time:

72 hours

Setup:

Mon - Sun

Units:

Index

Department:

Hepatitis B

Methodology:

The Atellica IM HBsII assay is a sandwich immunoassay using direct chemiluminometric technology. The Ancillary Reagent containing biotinylated anti-HBs mouse monoclonal capture antibodies and an acridinium ester-labeled anti-HBs mouse monoclonal antibody is added to the sample. The HBsAg in the sample complexes with the antibodies. A second acridinium ester-labeled anti-HBs mouse monoclonal antibody is added from the primary reagent pack. Streptavidin coated magnetic latex particles in the Solid Phase capture the HBsAg-antibody complexes.
The sample is incubated with Ancillary Reagent, and then with Solid Phase and Lite Reagent. Antibody-antigen complexes will form if hepatitis B surface antigen is present in the sample. A direct relationship exists between the amount of HBsAg 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.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Fridge:

21 days at <= -21 C

Clinical Info:

The Atellica® IM Hepatitis B surface Antigen II (HBsII) assay is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult, adolescent, and pediatric serum and plasma (potassium EDTA, lithium heparin, and sodium heparin), and neonatal samples using the Atellica® IM Analyzer. The assay may be used in conjunction with other serological and clinical information to diagnose
individuals with acute or chronic hepatitis B infection. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.

Test Limitations:

- The Atellica IM HBsII assay is limited to the detection of HBsAg in human serum and plasma (potassium EDTA, lithium heparin, and sodium heparin).
- It is recognized that the current methods for the detection of hepatitis B surface antigen may not detect all potentially infected individuals. A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis B. A nonreactive test result in individuals with prior exposure to hepatitis B may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay.
CAUTION: It has been reported that certain assays will not detect all HBV mutants. If acute or chronic HBV infection is suspected and the HBsII result is nonreactive, it is recommended that other HBV serological markers be tested to confirm the HBsII nonreactivity.
- A reactive HBsII result does not exclude co-infection by another hepatitis virus.
- Assay performance characteristics have not been established for the Atellica IM HBsII assay used in conjunction with other manufacturers' assays for specific HBV serological markers.
- 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.
- For diagnostic purposes, the Atellica IM HBsII test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.
- 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.
- Patients taking biotin supplements may have false negative results with this assay. Patient samples containing biotin of greater than 75 ng/mL may produce false negative results.

Test Information:

Components: