HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum
Use
This test is useful for detecting HIV-1 and HIV-2 infection in symptomatic patients older than 2 years. It is also used for follow-up testing of symptomatic individuals with reactive rapid HIV test results. It should not be used as a screening or confirmatory test for blood donor specimens.
Special Instructions
Not provided.
Limitations
The electrochemiluminescence immunoassay used in this test does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. A reactive screening test result is not diagnostic for HIV infection and should be considered preliminary. False-positive or false-negative results may occur, particularly in individuals with experimental HIV-1 vaccines, individuals undergoing antiretroviral therapy, or those taking pre-exposure or post-exposure prophylaxis. Assay performance characteristics have not been established for grossly hemolyzed, lipemic, icteric, heat-inactivated specimens, or specimen types other than serum.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
HIV-1 antibody
AntibodyHIV-1 p24 antigen
ProteinHIV-2 antibody
Antibody
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
Serum gel, submission in a plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions and aliquot serum into a plastic vial 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 |