Human Immunodeficiency Virus 1 & 2 (HIV-1/HIV-2), Qualitative, RNA
Use
This test is intended for use as an aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary infection. Presence of HIV-1 or HIV-2 RNA in the plasma of patients without antibodies to HIV-1 or HIV-2 is indicative of acute or primary HIV-1 or HIV-2 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 and/or HIV-2 antibodies. This assay is not intended for use in donor testing.
Special Instructions
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Limitations
Due to the potential cross-reactivity between some NAT assays and certain lentiviral vector-based CAR-T cell therapies, clinicians should exercise caution when ordering and interpreting HIV testing in patients who have received CAR-T cell therapy. Some lentiviral CAR-T vectors contain a target region of the test, which can lead to false positive HIV-1 results.
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 96557-4
- 25835-0
- 69353-1
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
1 mL
Minimum Volume
650 µL
Container
Lavender-top (EDTA) tube, BD SST tube, BD Vacutainer PPT plasma preparation tube
Collection Instructions
Collect specimen in lavender-top (EDTA), gel-barrier (SST tube) or a PPT plasma preparation tube. Specimens centrifugation within 24 hours of collection. Transfer serum or plasma to a polypropylene screw-cap tube for shipment.
Storage Instructions
Refrigerated or frozen
Causes for Rejection
Specimen grossly hemolyzed; specimen received at room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 6 weeks |