HIV Genotypic Resistance Assay

Sanger sequencing is performed to determine the nucleotide sequence of amplified HIV-1 target regions, specifically the protease and reverse transcriptase (RT) genes. These regions are important for HIV-1 genotypic resistance testing because mutations in the protease gene can confer resistance to protease inhibitors, whereas mutations in the RT gene may result in resistance to nucleoside and non-nucleoside reverse transcriptase inhibitors.

The generated sequence data are analyzed using the Stanford HIV Drug Resistance Database to identify recognized resistance-associated mutations and produce a genotype report. The report provides clinically relevant information to support antiretroviral therapy selection by predicting viral susceptibility or resistance to specific agents.

Specimens with HIV-1 RNA levels below 20 copies/mL are rejected before RNA extraction. The assay demonstrates an approximate sensitivity of 1,000 copies/mL at a 95% confidence level.

This assay was developed, and its performance characteristics were established, by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the U.S. Food and Drug Administration.

For integrase strand transfer inhibitor (INSTI) resistance testing, refer to the HIV-1 Genotypic Resistance Assay for Integrase Inhibitors (INSTIs).

HVINTA, HIV Integrase Resistance Assay [HVINTA]