Pandit A, Mackay W G, Steel C, van Loon A M, Schuurman R
Quality Control for Molecular Diagnostics, West of Scotland Science Park, Glasgow G20 0SP, Scotland, UK.
J Clin Virol. 2008 Dec;43(4):401-6. doi: 10.1016/j.jcv.2008.08.021. Epub 2008 Nov 1.
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.
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.
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.
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.
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.
耐药性检测在为HIV感染者选择最佳治疗方案中起着关键作用。进行检测的实验室必须实施包括外部质量评估在内的质量控制措施。
ENVA7计划（2007年）由QCMD组织，旨在评估检测HIV-1蛋白酶和逆转录酶基因耐药性突变的实验室的性能。
ENVA7样本组由5个冻干血浆样本组成（HIV-1 B、C和F亚型）。这些病毒在PR和RT基因的不同位置携带野生型或耐药基因型。使用为便于实验室和/或技术之间进行简单和标准化比较而开发的评分系统，将所有国际艾滋病协会定义的耐药相关密码子与每个样本的共有序列进行比较评分。
来自44个国家的111个实验室参与其中，95个实验室提交了98个数据集。36个数据集使用ViroSeq（雅培公司）生成，27个使用TruGene（西门子公司）生成，35个使用内部检测方法生成。
所有技术都成功地对样本组中的每个样本进行了基因分型，无论病毒亚型如何。虽然用于HIV基因型耐药性测定的检测方法已发展成为能够产生高质量结果的可靠且技术上可行的程序，但不同实验室之间仍观察到结果质量存在差异。
