2005—2019年我国HIV-1病毒载量检测实验室能力验证考核结果分析  

The results of proficiency test of HIV-1 viral load testing laboratories in China from 2005 to 2019

作　　者：薛云鹏 张鑫 朱祈钰 刘静 陶晓霞[1] 江华州 张岭[1] 蒋岩[1] 金聪[1] 潘品良[1] Xue Yunpeng;Zhang Xin;Zhu Qiyu;Liu jing;Tao Xiaoxia;Jiang Huazhou;Zhang Ling;Jiang Yan;Jin Cong;Pan Pinliang(National Center for AIDS/STD Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

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参比实验室,北京102206

出　　处：《中华实验和临床病毒学杂志》2021年第2期135-139,共5页Chinese Journal of Experimental and Clinical Virology

基　　金：国家科技重大专项(2018ZX10101002-004-003, 2018ZX10301102-003);北京市科技计划课题(D171100006717001)。

摘　　要：目的评估我国1型艾滋病病毒(HIV-1)载量检测实验室的检测能力,为进一步提高实验室检测结果的准确性提供数据参考。方法对2005—2019年由国家艾滋病参比室统一发放至各实验室的155份阳性考核样品的检测结果进行分析,按照检测方法和样本编号分组,计算均值(M)和标准差(S),通过独立样本t检验评价经济状况和参与考核年限对实验室检测结果稳定性的影响,采用单因素方差分析评价机构类型和试剂种类对实验室检测结果稳定性的影响。结果 HIV-1病载检测实验室由2005年的13家增加到2019年的267家,参评机构以疾控机构和医院为主。2015年以来,实验室考核优秀率保持在85%以上,不合格率在3%以下,影响因素分析显示,参与PT考核年限和使用检测试剂种类可影响实验室检测结果的稳定性,参与考核时长≥5年的实验室具有更好的检测稳定性。结论参加能力验证考核有助于提高我国实验室的HIV-1病毒载量检测能力。Objective To evaluate the testing capacity of HIV-1 viral load testing laboratories,and to provide data references for further improving the accuracy of laboratory test result in China.Methods The test result of 155 positive samples distributed by the National AIDS Reference Laboratory to each laboratory from 2005 to 2019 were summarized and grouped according to the test assay and sample number.The independent sample t-test was used to evaluate the economic status and the proficiency testing(PT)assessment period on the stability of the test results.And,one-way analysis of variance was used to evaluate the influence of the types of laboratories and reagents on the stability of test results.Results The number of HIV-1 viral load testing laboratories increased from 13 in 2005 to 267 in 2019.The participating institutions were mainly centers for disease control and prevention(CDC)and hospitals.Since 2015,the excellent rate of laboratories has remained above 85%,and the unqualified rate has remained below 3%.The associated factor analysis showed that the laboratory testing stability of HIV-1 viral load associated with the PT assessment period and the types of testing reagents,and the laboratories participating in the PT assessment for more than 5 years showed better stability.Conclusions Participating in the annual proficiency testing program helped improve the laboratory capability of HIV-1 viral load testing in China.

关 键 词：1型艾滋病病毒 病毒载量 能力验证 

分 类 号：R512.91[医药卫生—内科学]