HIV Antigen and Antibody Prenatal Routine Screen, Serum
Use
This test is used for screening HIV-1 and HIV-2 infection in nonsymptomatic pregnant patients. It is not intended for use as a screening or confirmatory test for blood donor specimens. Routine screening begins with an HIV-1/-2 antigen and antibody screening test, typically performed by various FDA-approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, and chemiluminescent immunoassays.
Special Instructions
Not provided.
Limitations
This test has not been licensed by the FDA for the screening of blood, plasma, cells, tissues, and cellular and tissue-based product donors. It is not diagnostic on its own and should be used in conjunction with supplemental tests for confirmation. False positives may occur in populations with low HIV prevalence. Performance characteristics have not been established for specimens that are grossly hemolyzed, lipemic, icteric, or heat-inactivated.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
HIV-1 p24 antigen
Protein
LOINC Codes
- 56888-1 - HIV 1+2 Ab+HIV1 p24 Ag SerPl Ql IA
- 56888-1 - HIV 1+2 Ab+HIV1 p24 Ag SerPl Ql IA
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
1 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions, aliquot within 2 hours of collection.
Storage Instructions
Frozen (preferred) for 30 days, or refrigerated for 6 days.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus, heat-inactivated specimen
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 30 days |