HIV-1 Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma
Use
The test identifies HIV-1 genotypic mutations associated with resistance to nucleotide and non-nucleoside reverse-transcriptase inhibitors, protease inhibitors, and integrase strain transfer inhibitors. It aids in guiding initiation or change of combination antiretroviral therapy in individuals, including children, with HIV-1 infection. The detection and analysis of antiviral drug resistance-associated viral genotypic mutations can guide necessary changes to suppress viral replication, thereby improving patient outcome.
Special Instructions
Patients must have a confirmed plasma HIV-1 RNA level of 1000 copies/mL or higher within the preceding 30 days to request this test. If the viral load is unknown, a different test (HIQDR) should be ordered, which includes viral load quantification and reflexes to genotypic drug resistance if appropriate. Ship the specimen frozen if delay exceeds 24 hours; freeze at -70 degrees C for up to 60 days on dry ice for shipment.
Limitations
The ability of the assay to amplify the target and detect genotypic mutations is poor when the plasma HIV-1 viral load is less than 1000 copies/mL. Minor drug-resistant variants detection varies with viral load: 20% or higher at VL of 1000 copies/mL, 10% or higher at VL of 5000 copies/mL, and 5% or higher at VL of 15,000 copies/mL. Absence of resistance does not rule out resistant virus reservoirs in the individual. Expert interpretation is recommended due to result complexity, influenced by patient compliance, drug interactions, and other factors.
FDA ApprovedNew York Approved
Methodology
NGS (Targeted)
Biomarkers
LOINC Codes
- 90901-0
- 80689-3
- 100984-4
- 45175-7
- 100983-6
- 30287-7
- 30284-4
- 41402-9
- 30283-6
- 30286-9
- 41396-3
- 30282-8
- 45176-5
- 91897-9
- 30291-9
- 52749-9
- 30289-3
- 68463-9
- 33630-5
- 100985-1
- 49618-2
- 49630-7
- 51409-1
- 49619-0
- 42000-0
- 30294-3
- 49621-6
- 49622-4
- 61199-6
- 100986-9
- 90080-3
- 96566-5
- 72857-6
- 72526-7
- 72525-9
- 89543-3
Result Turnaround Time
3-10 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
2.2 mL
Minimum Volume
0.8 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
Freeze plasma specimen at -70 degrees C (up to 60 days) until shipment on dry ice.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 60 days |