Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China.
Mol Diagn Ther. 2010 Feb 1;14(1):31-41. doi: 10.1007/BF03256351.
Transmission of antiretroviral drug-resistant strains of HIV-1 has a major impact on the success of HIV treatment regimens in most countries where antiretroviral therapy (ART) is available. It is now recommended that HIV-1 drug resistance be monitored in order to recommend appropriate therapy for infected ART-naïve individuals, or when choosing a new regimen for those patients not responding to ART. Commercial assays for the analysis of HIV-1 genotypic resistance have been approved by the US FDA. In China, several laboratories and research enterprises have been developing related assays, but at present, no systematic standardization or quality control for genotypic resistance assays has been established in China. A national reference panel is needed to evaluate and control the quality of HIV-1 genotype resistance assays in China.
A panel of five HIV-1 stocks (G1, G2, G3, G4, and G5) with well-characterized drug resistance was used to evaluate the resistance-mutation inclusivity of HIV-1 clades prevalent in China. Six samples (GS1-GS6) were used to evaluate the limit of detection (LOD) for the viral load levels, and five samples (GSS1-GSS3, GSS5, and GSS6) were used to evaluate the LOD for the percentages of mutant species within the range of detection. The samples were evaluated by five separate laboratories using one or two methods each, generating seven datasets in all.
In samples G1-G5, which were used to evaluate inclusivity of HIV-1 clades, 92.86-100%, 16.67-83.33% and 4.17-8.33% of the most, intermediately, and least common resistance mutations, respectively, were reported by the seven datasets. For the LOD samples, four of the seven datasets reported correct resistance mutations in samples with minimal viral loads of >2 x 10(3) copies/mL, as well as in samples with >40% of mutants and viral loads of about 1 x 10(4) copies/mL; the other three tests did not amplify the target region or identify the mutants.
The results were quite variable between different tests. The panel of HIV-1 genotypic resistance could be used as a control for resistance testing in China.
在大多数提供抗逆转录病毒疗法（ART）的国家，HIV-1 耐药株的传播对 HIV 治疗方案的成功产生了重大影响。现在建议监测 HIV-1 耐药性，以便为感染的未经 ART 治疗的个体推荐适当的治疗方法，或者在选择新方案治疗对 ART 无反应的患者时。美国 FDA 已批准用于分析 HIV-1 基因型耐药性的商业检测方法。在中国，一些实验室和研究企业一直在开发相关检测方法，但目前尚未在中国建立基因型耐药性检测的系统标准化或质量控制。需要一个国家参考面板来评估和控制中国 HIV-1 基因型耐药性检测的质量。
使用一组具有明确耐药特征的五种 HIV-1 株（G1、G2、G3、G4 和 G5）来评估中国流行的 HIV-1 群耐药突变的包容性。使用六个样本（GS1-GS6）来评估病毒载量水平的检测限（LOD），使用五个样本（GSS1-GSS3、GSS5 和 GSS6）来评估检测范围内突变种百分比的 LOD。使用一种或两种方法，由五个独立实验室分别对七个样本进行了评估，共产生了七个数据集。
在用于评估 HIV-1 群耐药突变包容性的 G1-G5 样本中，七个数据集分别报告了最常见、中等常见和最不常见耐药突变的 92.86-100%、16.67-83.33%和 4.17-8.33%。对于 LOD 样本，七个数据集中有四个在最小病毒载量>2×10(3)拷贝/ml 的样本中以及在>40%突变体和约 1×10(4)拷贝/ml 的病毒载量样本中报告了正确的耐药突变；其他三个测试未扩增目标区域或识别突变体。
不同测试之间的结果差异很大。HIV-1 基因型耐药性面板可作为中国耐药性检测的对照。
