PrEP Use Only: Human Immunodeficiency Virus 1 & 2 (HIV-1/HIV-2), Qualitative, RNA
Also known as: HIV, PrEP, Prophylaxis
Use
PrEP use only: This test is intended for patients being evaluated for pre-exposure prophylaxis (PrEP) regimens 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
This test is designated for PrEP use only and contains a CPT code modifier for the CARES Act.
Limitations
This assay is not intended for use in donor testing. The minimum volume required does not allow for repeat testing, and grossly hemolyzed specimens or those at room temperature upon receipt are not acceptable.
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 or 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 require centrifugation within 24 hours of collection. Transfer serum or plasma to a polypropylene screw-cap tube for shipment. Ship frozen.
Storage Instructions
Freeze (preferred) or refrigerate.
Causes for Rejection
Specimen grossly hemolyzed; room temperature specimen received
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 6 weeks |