HIV Integrase Resistance Assay

Sanger sequencing is performed to determine the nucleotide sequence of amplified HIV-1 target regions, specifically the integrase gene. This region is essential for HIV-1 genotypic resistance testing because mutations in the integrase gene are associated with resistance to integrase strand transfer inhibitors (INSTIs).

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

Specimens with HIV-1 RNA levels below 20 copies/mL are rejected prior to RNA extraction. The assay demonstrates an approximate sensitivity of 1,000 copies/mL at the 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 ordering information regarding resistance testing for protease inhibitors and nucleoside/non-nucleoside reverse transcriptase inhibitors, refer to the HIV-1 Genotypic Resistance Assay for Protease Inhibitors and Reverse Transcriptase Inhibitors.

HIVGRA, HIV Genotypic Resistance Assay [HIVGRA]