Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, PR China.
Mol Diagn Ther. 2011 Feb 1;15(1):41-52. doi: 10.1007/BF03257192.
With the introduction of the ViroSeq™ HIV-1 Genotyping System (ViroSeq™ assay) into China, it is important to evaluate the impact of the diversity of HIV-1 genotypes found in China on the performance of the ViroSeq™ assay compared with an in-house method.
A total of 318 plasma samples, collected from 206 HIV-1-infected patients receiving antiretroviral therapy and 112 treatment-naïve HIV-1-infected patients, were used for evaluating the concordance of genotypes, genotypic resistance mutations, and phenotypic resistance between the ViroSeq™ assay and an in-house method for analyzing HIV-1 drug resistance in China.
A concordance of genotypes between the ViroSeq™ assay and the in-house method was observed for the 313 samples (98.4%), using the Stanford University HIV Drug Resistance Database (Version 6.0.5). The overall concordances of drug-resistance-related mutations (DRRMs) in the HIV-1 protease (PR) and reverse transcriptase (RT) coding sequences within the HIV-1 pol gene, scored by the ViroSeq™ assay and the in-house method, were 99.5% and 98.1%, respectively. Discrepancies between the two methods were found in 38 samples assayed for protease inhibitor (PI) DRRMs, 36 samples assayed for nucleoside reverse transcriptase inhibitor (NRTI) DRRMs, and 72 samples assayed for non-nucleoside reverse transcriptase inhibitor (NNRTI) DRRMs, and 100%, 88.9%, and 87.5% of the samples with discrepancies for PI, NRTI, and NNRTI DRRMs, respectively, were genotyped as subtype B. One NNRTI mutation (the RT mutation Y318F) was reported only by the ViroSeq™ assay, and this discrepancy resulted from the difference in the pol gene lengths generated by the two systems. Furthermore, the overall concordance of phenotypic resistance was 94.7% (301/318) between the two methods.
The ViroSeq™ assay will be a useful tool for monitoring clinical drug resistance and for better management of HIV-1 patients receiving antiretroviral therapy in China.
随着 ViroSeq™ HIV-1 基因分型系统（ViroSeq™ 检测）在中国的引入，评估中国发现的 HIV-1 基因型多样性对该检测与中国内部方法比较的性能影响非常重要。
共使用 318 份来自 206 名接受抗逆转录病毒治疗的 HIV-1 感染患者和 112 名初治 HIV-1 感染患者的血浆样本，评估 ViroSeq™ 检测与中国内部方法分析 HIV-1 耐药性时在基因型、基因型耐药突变和表型耐药方面的一致性。
使用斯坦福大学 HIV 耐药数据库（版本 6.0.5），ViroSeq™ 检测与内部方法在 313 份样本（98.4%）中观察到基因型一致。HIV-1 pol 基因中 HIV-1 蛋白酶（PR）和逆转录酶（RT）编码序列中与药物耐药相关的突变（DRRMs），ViroSeq™ 检测与内部方法评分的总一致性分别为 99.5%和 98.1%。在检测蛋白酶抑制剂（PI）DRRMs 的 38 份样本、检测核苷逆转录酶抑制剂（NRTI）DRRMs 的 36 份样本和检测非核苷逆转录酶抑制剂（NNRTI）DRRMs 的 72 份样本中发现两种方法之间存在差异，分别有 100%、88.9%和 87.5%的差异样本的基因型鉴定为 B 亚型。ViroSeq™ 检测仅报告了一个 NNRTI 突变（RT 突变 Y318F），这一差异是由两种系统产生的 pol 基因长度不同所致。此外，两种方法之间表型耐药的总体一致性为 94.7%（301/318）。
ViroSeq™ 检测将成为监测临床耐药性和更好地管理中国接受抗逆转录病毒治疗的 HIV-1 患者的有用工具。
