HIV Integrase Resistance Assay

Sanger sequencing is used to determine the nucleotide sequence of amplified HIV target regions, specifically the integrase gene. This gene is critical for HIV genotyping because mutations within the integrase gene are associated with resistance to integrase inhibitors (INSTIs). The resulting sequence data are analyzed and submitted to the Stanford HIV Drug Resistance Database, which identifies known resistance-associated mutations and generates a genotype report. This report provides clinically relevant information to guide antiretroviral therapy selection by indicating which drugs the virus may be resistant or susceptible to.

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

This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the US Food and Drug Administration.

For ordering: HIV Genotypic Resistance Assay for the protease inhibitors and nucleoside and non-nucleoside reverse transcriptase inhibitors

HIVGRA, HIV Genotypic Resistance Assay [HIVGRA]

6 mL blood in LAVENDER TOP, PEARL PPT, RED top or SST tube

Unacceptable: GREEN TOP, Extracted nucleic acid from an outside laboratory.