HIV-1/HIV-2 RNA Detection, Serum
Use
This test is essential for diagnosing HIV-1 and/or HIV-2 infection in individuals with indeterminate or inconclusive HIV serologic test results. It is also used for individuals suspected to be in the acute/early HIV infection stage, often referred to as the 'window period'. Additionally, this testing plays a crucial role in diagnosing HIV-1 and/or HIV-2 infection in infants under 18 months who are born to HIV-infected mothers.
Special Instructions
Not provided.
Limitations
This test is not licensed by the US FDA for screening HIV-1 in blood donors or human cells, tissues, or tissue products. An 'Undetected' result might not rule out HIV infection if the specimen was collected too soon after exposure or improperly processed/stored. It fails to detect rare HIV variants and has limitations in specimens that could contain inhibitory substances. Therefore, care must be taken in specimen processing, collection, and selection to avoid these pitfalls.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
HIV-1 RNA
MicroorganismHIV-2 RNA
Microorganism
LOINC Codes
- 96557-4 - HIV 1 + 2 RNA Pnl SerPl NAA+probe
- 25835-0 - HIV1 RNA SerPl Ql NAA+probe
- 69353-1 - HIV 2 RNA SerPl Ql NAA+probe
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
Serum gel
Collection Instructions
Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial. Then freeze the aliquoted serum for shipment.
Storage Instructions
Ship specimen frozen on dry ice. If shipment is delayed more than 24 hours, freeze serum specimen at -20 to -80 degrees C until shipment on dry ice.
Causes for Rejection
Gross hemolysis or gross lipemia.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 40 days |