Hepatitis B Virus Surface Antigen Confirmation, Prenatal, Serum
Use
This test is used for the diagnosis of acute, recent, or chronic hepatitis B in prenatal patients. It is specifically designed to confirm the presence of hepatitis B surface antigen (HBsAg) in serum samples from prenatal patients, indicating ongoing hepatitis B virus infection which could potentially be transmitted from mother to child during delivery. The test is not suitable as a stand-alone prenatal screening test for HBsAg status in pregnant women.
Special Instructions
The test is not orderable as a stand-alone prenatal screening test of HBsAg status in pregnant women and is not offered as a screening or confirmatory test for blood donor specimens. It should be noted that a positive result may need to be reported to state health departments.
Limitations
This assay is not licensed by the FDA for screening blood, plasma, or tissue donors. A negative result does not exclude the possibility of HBV infection, particularly if obtained for individuals with past exposure or the presence of low antigen concentrations. Current methods may not detect all infected individuals and performance characteristics of the assay have not been established for newborns or certain specimen types, such as cadaveric specimens or grossly hemolyzed samples.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 7905-3
- 7905-3
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.8 mL
Minimum Volume
0.7 mL
Container
Serum gel (red-top tubes not acceptable), Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions, aliquot serum into a plastic vial within 2 hours of collection for BD Vacutainer tubes.
Causes for Rejection
Gross hemolysis, Gross lipemia, Gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 6 days |
| Frozen | 90 days |