HIV Antigen and Antibody Prenatal Routine Screen, Plasma
Use
This test is used for screening HIV-1 and HIV-2 infection in nonsymptomatic pregnant patients. It starts with an HIV-1/-2 antigen and antibody (Ab) screen using electrochemiluminescence immunoassay, and further confirmation/differentiation tests are performed based on the initial result. The test is not suitable as a screening or confirmatory test for blood donor specimens.
Special Instructions
If the specimen is obtained from autopsy or cadaver blood sources, order the FDA-approved test HV1CD instead. This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State due to specific regulatory requirements for expedited result reporting.
Limitations
The assay performance characteristics have not been established for grossly hemolyzed, lipemic, or icteric specimens, nor for heat-inactivated or cadaveric specimens. A reactive result is considered preliminary and should not be used for diagnostic purposes without confirmatory testing. False-positive results can occur, particularly in populations with low prevalence of infection, and in individuals who have received experimental HIV-1 vaccines or mouse monoclonal antibodies.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 56888-1
- 56888-1
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
1.5 mL
Minimum Volume
1 mL
Container
Plastic vial
Collection Instructions
Centrifuge the blood collection tube as per manufacturer's instructions and transfer plasma into a plastic vial within 2 hours.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus, heat-inactivated specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 30 days |