Hepatitis B Virus Surface Antigen Screen, Serum
Use
This test is used for the diagnosis of acute, recent, or chronic hepatitis B and determination of chronic hepatitis B status. It is not offered for screening or confirmatory testing of blood donor specimens. This test is also not useful for the diagnosis of hepatitis B during the 'window period' of acute infection, which occurs after the disappearance of hepatitis B surface antigen and prior to the appearance of hepatitis B surface antibody.
Special Instructions
It is recommended to use this test for nonpregnant, asymptomatic individuals who may or may not have risk factors for hepatitis B virus infection. This test should not be used for symptomatic individuals or for testing chronic hepatitis B in pregnant individuals. It is not intended for testing cadaver or grossly hemolyzed specimens.
Limitations
The assay is not licensed by the FDA for screening blood, plasma, and tissue donors. Individuals recently vaccinated against hepatitis B may have transient positive results. The assay may not detect all infected individuals and false-positive results can occur due to high levels of antibodies. Current methods may not detect all infected individuals. Negative results do not completely exclude the possibility of infection. Performance characteristics are not established for newborn testing or other manufacturers' assays.
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
Serum gel, Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, Gross lipemia, Gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 6 days |
| Frozen | 90 days |