HIV‑1 Genotype (RTI, PI, Integrase Inhibitors)
Also known as: Human Immunodeficiency Virus
Use
Genotypic resistance testing of HIV‑1 reverse transcriptase inhibitors (RTIs), protease inhibitors (PIs), and integrase inhibitors is indicated at entry into care, during pregnancy before therapy initiation, and upon virologic failure with detectable HIV RNA levels. When integrase inhibitor resistance is suspected (e.g., from transmitted INSTI resistance or prior exposure to long‑acting cabotegravir or INSTI‑based prophylaxis), the integrase gene is included in testing panels to guide antiretroviral therapy selection. A minimum plasma viral load of approximately 500–1,000 copies/mL is recommended for successful genotype amplification; if RNA levels are too low or undetectable, a proviral DNA–based resistance assay may be considered. This aids clinicians in tailoring effective ART regimens for individual patients.
Special Instructions
Not provided.
Limitations
A minimum HIV‑1 viral load of 500 to 1,000 copies/mL in plasma is recommended for reliable genotyping; samples with undetectable or very low viral load may fail amplification, and in such cases proviral DNA genotyping may be required. The assay is laboratory‑developed, validated under CLIA rules, and has not been cleared or approved by the US Food and Drug Administration.
Methodology
Sanger
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Not provided.