Hepatitis B Surface Antibody, Qualitative Quantitative
Alternate Name: HBsAb_Atellica
SAL Code:
811
CPT:
86706
Loinc:
16935-9
Turn Around Time:
24 hours
Setup:
Mon-Sun
Department:
Hepatitis B Surface Antibody Qualitative/Quantitative
Methodology:
The Atellica IM aHBs2 assay is a sandwich immunoassay using direct chemiluminescent technology. HBsAg (ad and ay) are covalently coupled to magnetic latex particles in the Solid Phase. In the Lite Reagent, the HBsAg (ad and ay) are labeled with acridinium ester. Non-magnetic latex particles are added from the ancillary well. The sample is incubated simultaneously with Lite Reagent, Solid Phase, and Ancillary Well Reagent. Antibody-antigen complexes will form if anti-HBs is present in the sample.
A direct relationship exists between the amount of anti-HBs activity present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Specimen Requirements:
Primary Tube:
SST
Primary Substance:
Serum
Temperature
Period
Stable Ambient:
7 days
Stable Fridge:
7 days at 2-8 C
Stable Frozen:
at: - 20 C for londer storage
Clinical Info:
The Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma (EDTA, lithium heparinized, or sodium heparinized) and neonatal samples using the
Atellica® CI Analyzer. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
Test Limitations:
- The Atellica IM aHBs2 assay is limited to the detection of antibodies to hepatitis B surface antigen in human serum and plasma (EDTA, sodium heparin, and lithium heparin).
- Assay performance characteristics have not been established for the Atellica IM aHBs2 assay used in conjunction with other manufacturers' assays for specific HBV serological markers. Laboratories are responsible for establishing their own performance characteristics.
- Assay performance characteristics have not been established in pregnant women, or in populations of immunocompromised or immunosuppressed patients; and therefore, users are responsible for establishing their own performance characteristics in these populations.
- This assay does not differentiate between a vaccine-induced immune response and an immune response induced by infection with HBV. To determine if the anti-HBs response is due to vaccine or HBV infection, a total anti-HBc assay may be performed.
- The performance of the Atellica IM aHBs2 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.
- This assay is not intended for use in screening blood or plasma donors.
- Results obtained with the Atellica IM aHBs2 assay may not be used interchangeably with values obtained with different manufacturers' assay methods.
- Individuals who have received blood component therapies, for example, whole blood, plasma, immunoglobulin administered during the previous 3–6 months, may have a false reactive anti-HBs result due to passive transfer of anti-HBs.
- The prevalence of the analyte in the population tested will affect the assay’s predictive value. A positive anti-HBs result does not exclude co-infection by another hepatitis virus.
Test Information:
Components:
| Component Name | CPT | Loinc |
| Hep B Surface Antibody, Qualitative | 16935-9 | Hep B Surface Antibody, Quantitative | 86706 | 16935-9 |