HIV-1 RNA Quantification with Reflex to Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma
Use
This test measures the viral load of HIV-1 RNA in individuals with known HIV-1 infection and helps identify genotypic mutations associated with resistance to various inhibitors: nucleotide and non-nucleoside reverse-transcriptase inhibitors, protease inhibitors, and integrase strand transfer inhibitors. It guides the initiation or change of combination antiretroviral therapy, providing crucial insights into the individual's response to therapy and the necessity for potential adjustments in treatment plans.
Special Instructions
Prior to ordering this test, the patient must have a confirmed HIV-1 infection. The test includes an initial RNA quantification process, and if the viral load is 1000 copies/mL or greater, reflex testing for drug resistance mutations is automatically performed. Proper specimen collection and handling are vital for the accuracy of the results.
Limitations
This test is not FDA approved for screening purposes in donor blood or other tissue products. It also cannot reliably quantify viral loads for HIV-1 groups N and HIV-2 strains. Plasma specimens need correct handling and storage to avoid falsely low or negative results. Results below 20 copies/mL may not indicate the absence of viral replication due to possible inhibitory substances in the specimen.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 70241-5
- 70241-5
Result Turnaround Time
1-10 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
3.6 mL
Minimum Volume
2 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube and aliquot plasma into plastic vial per collection tube manufacturer's instructions. Freeze aliquoted plasma for shipment.
Storage Instructions
Ship specimen frozen on dry ice. If shipment is delayed for more than 24 hours, freeze plasma specimen at -20 to -80 degrees C until shipment on dry ice.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 5 days |
| Frozen | 55 days |