Hepatitis B Virus Surface Antigen, Serum
Use
This test is used for the diagnosis of acute, recent, or chronic hepatitis B as well as for the determination of chronic hepatitis B status. It is not meant for screening or confirmatory testing in blood donor specimens.
Special Instructions
This test should be used for testing symptomatic individuals, regardless of the presence of risk factors for hepatitis B virus infection. It is not intended for screening asymptomatic, nonpregnant individuals with or without risk factors.
Limitations
The assay is not licensed by the FDA for screening blood, plasma, or tissue donors. False positives may occur in individuals recently vaccinated with the hepatitis B vaccine. The test does not rule out infection if antigen levels are below detection limits or if antigens are nonreactive with the antibodies used in the assay. Assay performance is not established for certain specimen types, including icteric, lipemic, hemolyzed, or particulate-contaminated specimens. Specimens other than serum are not validated.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 5196-1
- 5196-1
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.9 mL
Minimum Volume
0.7 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions. Aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, gross lipemia, and gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 6 days |
| Frozen | 90 days |