Test Code HBsAg Hepatitis B Surface Antigen
Additional Codes
Cerner |
NextGen |
Hepatitis B Surface Antigen |
Hepatitis B Surface Antigen |
Alternate Name(s)
HBAG
HBs Ag
Methodology
Vitros- Antibody Neutralization and Immunometric
Patient Preparation
None
Collection Instructions
Standard phlebotomy practices.
Centrifuge specimens and remove serum from all cellular material within 2 hours of collection.
Specimen Requirements
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Stability |
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Rejection Criteria |
Gross Hemolysis Turbid Specimens |
Result Reporting and Reference Values
Negative, all ages.
Reflex Testing
The presence of HBsAg in samples found to be reactive in the VITROS HBsAg test will undergo confirmation by a neutralization reaction using human antibody to HBsAg (anti-HBs) before a positive HBsAg is reported.
Limitations
- No known interferences.
- The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.
- Heterophilic antibodies (e.g. human anti-mouse) in the serum of certain individuals are known to cause interference with immunoassays. These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products.
- Individuals recently vaccinated for hepatitis B may give a transient positive result for HBsAg because of its presence in the vaccine.
- HBsAg results should only be used and interpreted in the context of the overall clinical picture. A negative test does not exclude the possibility of exposure to or infection with hepatitis B virus. Levels of HBsAg may be undetectable both in early infection and late after infection. In rare cases HBsAg tests do not detect certain HBV mutant strains.
- The ability of the VITROS HBsAg test to detect HBV mutants has not been determined. Testing using alternative methodologies may be warranted if signs, symptoms, and risk factors are indicative of viral hepatitis and other laboratory tests for the diagnosis of viral hepatitis are nonreactive.
Useful For
The VITROS Immunodiagnostic Products HBsAg Reagent pack detects hepatitis B surface antigen (HBsAg) in human serum using the VITROS XT 7600 Integrated Systems. Assay results, in conjunction with other serological and clinical information, assist in diagnosis of individuals with acute or chronic hepatitis. In addition, this assay can screen pregnant women for hepatitis B infection, identifying neonates who are at high risk of acquiring HBV during the perinatal period. The presence of HBsAg in samples found to be repeatedly reactive in the VITROS HBsAg test will undergo confirmation by a neutralization reaction using human antibody to HBsAg (anti-HBs).