| 斗智,江震,潘品良,宋炜路,徐杰,吴尊友.参比校正对中国15个大城市MSM人群HIV感染者病毒载量抽样调查结果的影响[J].中华流行病学杂志,2017,38(12):1683-1687 |
| 参比校正对中国15个大城市MSM人群HIV感染者病毒载量抽样调查结果的影响 |
| Effect of laboratory referencing on data analysis of community viral load in HIV positive MSM from 15 cities, China |
| 收稿日期:2017-01-20 出版日期:2017-12-26 |
| DOI：10.3760/cma.j.issn.0254-6450.2017.12.020 |
| 中文关键词: 艾滋病病毒 病毒载量 社区病毒载量 测量 参比校正 |
| 英文关键词: HIV Viral load Community viral load Measurement Referencing |
| 基金项目:国家科技重大专项（2012ZX10001-007-005） |
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| 中文摘要: |
| 目的 通过对HIV病毒载量（VL）实验室检测方法的参比校正，分析中国MSM人群HIV感染者（MSM感染者）社区VL水平（CVL）。方法 利用国家科技重大专项2014-2015年15个大城市MSM感染者VL抽样调查数据。15个大城市根据各自配置的检测设备、试剂完成VL检测。VL检测方法主要包括RT-PCR、核酸序列依赖性扩增法（NASBA）、分支DNA测定技术（bDNA）、雅培M2000（M2000）4种方法。按照国家HIV参比实验室2013-2015年VL能力验证结果，将EasyQ、bDNA和M2000这3种方法检测的VL值转换成相应的TaqMan 2.0检测的VL值，校正不同检测方法之间的参比关系。采用SPSS 17.0软件对数据进行描述性分析。结果 15个城市CVL对数均值参数校正前后，2014年分别为（2.38±1.47）、（2.99±1.31），2015年分别为（2.07±1.34）、（2.72±1.19）。分别以VL水平≤ 200拷贝/ml、≤ 400拷贝/ml、≤ 1 000拷贝/ml作为VL成功抑制标准，对参比校正VL值前后比例进行比较发现，以VL水平 ≤ 400拷贝/ml及 ≤ 1 000拷贝/ml标准的参比校正前后数据变化幅度较小。结论 各地区保持统一的检测方法，能增加各年度间VL的可比性；以VL ≤ 400拷贝/ml或 ≤ 1 000拷贝/ml作为人群VL成功抑制标准，进行各地区间VL比较，数据稳定性较好。 |
| 英文摘要: |
| Objective To compare the community viral load (CVL) among MSM in 15 cities in China using standardized national reference sources.Methods The study analyzed the existing database of National Major Science and Technology Project of China. The database was established with serial random survey of MSM HIV CVL among MSM in 15 cities from 2013 to 2015. VL tests were conducted in 15 laboratories with different equipment and methods, including RT-PCR, nucleic acid sequence based amplification (NASBA), branched DNA testing (bDNA) and Abbott M2000 RealTime system (M2000). Based on proficiency test for 15 laboratories conducted by National HIV Reference Laboratory, VL test values detected with EasyQ, bDNA and M2000 were converted and standardized into resultant values of TaqMan 2.0. Software SPSS 17.0 was used to produce descriptive statistics for the dataset.Results From 2014 to 2015, the 15 testing sites were found to use a number of different viral load detection techniques. In 2014, the community viral load values were (2.38±1.47) and (2.99±1.31) in 15 testing sites, while in 2015 these values were found to be (2.07±1.34) and (2.72±1.19). The measurement of community VL was done using standard benchmarks of ≤ 200 copies/ml, ≤ 400 copies/ml and ≤ 1 000 copies/ml, that were used for reference for now.Conclusion It is necessary to use standard detection method to improve the comparability of annual results. Using a standardized rate of ≤ 400 copies/ml or ≤ 1 000 copies/ml for successful control of VL was found with high stability for the result comparison among different areas. |
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