HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Serum
Use
Confirmation and differentiation of HIV-1 and HIV-2 antibodies in serum specimens that show reactive results with third- and fourth-generation HIV serologic assays. This test is useful for confirmation and differentiation in cadaveric blood or hemolyzed serum specimens that show reactive results with initial HIV serologic screening assays. It aids in determining the presence of HIV-1 or HIV-2 infection in individuals with reactive initial tests. However, it is not suitable for screening in symptomatic or asymptomatic individuals or for maternal or newborn screening in New York State.
Special Instructions
This test is not a screening test for HIV infection in symptomatic or asymptomatic individuals. It is not to be used for blood donor specimens or maternal/newborn HIV screening for specimens originating in New York State. If testing is needed for autopsy or cadaver blood sourced specimens, another FDA-licensed assay should be ordered.
Limitations
A negative result for both HIV-1 and HIV-2 antibodies does not rule out acute HIV infection. Assay performance is not established for heat-inactivated or cadaveric specimens, presence of particulate matter, or samples from HIV-1 vaccine recipients. Such cases may lead to misleading results due to potential cross-reactivity.
FDA ApprovedNew York Approved
Methodology
Immunoassay (Rapid Immunochromatographic Assay)
Biomarkers
LOINC Codes
- 89365-1
- 68961-2
- 81641-3
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
0.8 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions and aliquot serum into a plastic vial within 2 hours of collection.
Causes for Rejection
Gross hemolysis, gross lipemia, and gross icterus are acceptable.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 30 days |