HIV-1 drug resistance genotyping quality assessment: results of the ENVA7 Genotyping Proficiency Programme

Abstract

Background: Drug-resistance testing plays a critical role in selection of optimal treatment regimens for HIV infected individuals. Laboratories performing testing must implement quality control measures including external quality assessment.

Objectives: The ENVA7 Programme (2007) was organised by QCMD to assess the performance of laboratories testing for drug-resistance mutations in the HIV-1 Protease and Reverse Transcriptase genes.

Study design: The ENVA7 panel consisted of 5 lyophilised plasma samples (HIV-1 subtypes B, C and F). The viruses harboured wild type or resistant genotypes at various positions of the PR and RT genes. All IAS-defined resistance-associated codons were scored in comparison to the consensus sequence for each sample using a scoring system developed to allow simple and standardised comparisons between laboratories and/or technologies.

Results: 111 laboratories from 44 countries participated of which 95 submitted 98 datasets. 36 datasets were generated using ViroSeq (Abbott), 27 using TruGene (Siemens) and 35 using in-house assays.

Conclusions: All technologies successfully genotyped each of the panel samples, irrespective of the virus subtype. While the assays for genotypic HIV drug-resistance determination have evolved into reliable and technically capable procedures of generating high quality results, variation in the quality of results is still observed between laboratories.