某国产HIV-1病毒载量检测试剂的检测性能评估  

Evaluation of clinical application of a domestic HIV-1 viral load testing reagent

作　　者：何林[1] 万伟 朱祈钰 马洁琼 刘静 薛云鹏 蒋岩[1] 马丽英[1] 潘品良[1] 金聪[1] HE Lin;WAN Wei;ZHU Qiyu;MA Jieqiong;LIU Jing;XUE Yunpeng;JIANG Yan;MA Liying;PAN Pinliang;JIN Cong(National Center for AIDS/STD Control and Prevention,China CDC,Beijing 102206,China;School of Life Science,Bengbu Medical College,Anhui 233030,Bengbu;Department of Epidemiology,School of Public Health,China Medical University,Shenyang 110122)

机构地区：[1]中国疾病预防控制中心,性病艾滋病预防控制中心,北京102206 [2]蚌埠医学院生命科学学院,安徽蚌埠233030 [3]中国医科大学公共卫生学院流行病学教研室,沈阳110122

出　　处：《中国艾滋病性病》2020年第6期569-572,586,共5页Chinese Journal of Aids & STD

基　　金：国家“十三五”重大传染病专项(2018ZX10301102-003,2018ZX10734404-005)。

摘　　要：目的对1型艾滋病病毒(HIV-1)的国产病毒载量检测试剂进行检测性能评估。方法应用系列稀释的定值质控品分析某国产病毒载量检测试剂的检测线性度和精密度,应用81份HIV-1感染阳性样本和30份阴性样本比较该国产病毒载量检测试剂与进口TaqMan病毒载量检测试剂检测结果的相关性和一致性。结果国产病毒载量检测试剂对系列浓度定值质控品检测结果的线性相关系数为R^2=0.9970。对不同浓度定值质控品检测结果的批间和批内检测变异系数均<10%。与进口TaqMan病毒载量检测试剂相比较,两种检测试剂对临床样本检测结果之间的相关性系数为R^2=0.7923。比较两种试剂检测结果偏差的Bland-Altman分析显示偏差均值为-0.01 Log(拷贝/mL)。两种试剂判定阳性和阴性样本的检测符合率为100%。以1000拷贝/mL为检测线时,两种试剂检测结果的符合率为93.83%;以5000拷贝/mL为检测线时,两种试剂检测结果的符合率为91.36%。结论某国产病毒载量检测试剂具有较好的检测线性和精密度,与进口TaqMan病毒载量检测试剂相比具有较好的相关性和一致性,整体检测性能良好可适用于大部分临床检测需求。Objective To evaluate the performance and clinical application of a domestic HIV-1 viral load testing reagent.Methods Serial diluted quality control samples were used to evaluate testing linearity and precision.81 HIV positive samples and 30 negative samples were used to evaluate the correlation,bias,and agreement with the imported Taq Man viral load testing reagent.Results As for serial diluted quality control samples,the domestic testing reagent had testing linearity coefficient R^2=0.9970.At all tested viral load levels,the within-run and between-run variations were less than 10%.In comparison with the imported reagent,the domestic testing reagent had a correlation coefficient R^2=0.7923,and the Bland-Altman analysis showed the bias was-0.01 Log(copies/mL).The coincidence rate of the domestic and imported reagents for determining positive and negative samples was 100%.And the coincidence rate of the two reagents was 93.83%and 91.36%when 1000 copies/m L and 5000 copies/m L were used as the testing threshold,respectively.Conclusion The domestic virus load testing reagent has good testing linearity and precision,and it shows the good correlation and consistency with the imported Taq Man virus load testing reagent.The analytical and clinical testing performance of the domestic virus load testing reagent is satisfactory and can meet the requirements of the most clinical applications.

关 键 词：1型艾滋病病毒 病毒载量检测 国产检测试剂 检测性能评估 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]