2013-2015年全国HIV-1病毒载量检测能力验证方法的比较

目的 通过分析2013-2015年全国HIV-1病毒载量检测能力验证（VQA-PT）结果，了解法国bioMerieux公司的NucliSens EasyQ HIV-1 v2.0（EasyQ）、美国Siemens Healthcare Diagnostics公司VERSANT HIV-1 RNA 3.0 assay（bDNA）、美国罗氏分子诊断公司COBAS AmpliPrep/COBAS TaqMan HIV-1 test（Taqman）、美国Abbott Molecular公司Abbott Real Time HIV-1 Kit（M2000）、中山大学达安基因股份有限公司和东北制药集团辽宁生物医药有限公司的HIV-1核酸定量检测试剂盒（国产试剂）5种方法检测结果之间的定量换算关系，为不同方法检测HIV-1病毒载量结果的横向比较提供参考。方法 参照《HIV-1病毒载量测定及质量保证指南》（2013版）的要求，由中国CDC性病艾滋病预防控制中心参比实验室统一组织全国HIV-1的VQA-PT。采用多中心回溯性研究方法，2013-2015年共计考核6次，考核实验室155家，涉及阳性样本22个，相应结果2 954个。针对每个阳性样本的所有结果，首先转换为对数值，而后按照检测方法分类，计算对数值的均值，获得不同方法检测相同样本的一组数据。对最终获得的22组数据进行Bland-Altman分析和线性回归分析。结果 Bland-Altman分析显示，EasyQ及bDNA与Taqman的一致性为100%，M2000及国产试剂与Taqman的一致性≥ 90%。回归分析结果显示，EasyQ、bDNA、M2000及国产试剂检测结果在数值上与Taqman之间存在相应的换算关系（P<0.01）。结论 对于我国HIV-1感染者，使用不同病毒载量检测方法获得的结果一致性良好，不同方法的结果之间可以转换，进而对治疗效果进行分析评价。

Comparison of commercial HIV-1 viral load tests by using proficiency test results in China, 2013-2015

Objective To compare the bio-equivalence among commercial HIV-1 viral load tests, including EasyQ HIV-1 v2.0 (EasyQ) from bioMerieux NucliSens of France; VERSANT HIV-1 RNA 3.0 assay (bDNA) from Siemens Healthcare Diagnostics of USA; COBAS AmpliPrep/COBAS TaqMan HIV-1 test (Taqman) from Roche Molecular Diagnosis of USA; Abbott Real Time HIV-1 Kit (M2000) from Abbott Molecular of USA and two domestic HIV-1 viral load test kits (domestic kit) from DaAn Gene Company of Sun Yat-Sen University and Liaoning Bio-Pharmaceutical company of Northeast pharmaceutical group, by using proficiency test results in China from 2013 to 2015. Methods A total of 2 954 proficiency test results, obtained from 22 positive samples of 6 proficiency tests in 155 laboratories conducted by China CDC were analyzed during 2013-2015. The results from each sample were first logarithmic transformed and then grouped according to the method used, the mean value of logarithmic results was calculated. Subsequently, 22 clusters of mean values were analyzed by Bland-Altman analysis for the consistency, and linear regression analysis for the interdependency. Results The results indicated that, by taking Taqman as the reference, EasyQ, M2000, bDNA and domestic kit had good consistency (90%-100%) and interdependency. Conclusion All the viral load tests were bio-equivalent. Moreover, according to the conversion formula derived from domestic proficiency test results, all the viral load results could be converted, which is critical for epidemiological analysis.