摘要
目的评价一种HIV抗体快速确证试剂在临床应用中的价值和质量性能。方法按照检测流程进行HIV抗体筛查和确证检测,对评价试剂和对比试剂的符合性进行分析,分析评价试剂在HIV感染诊断中的敏感性和特异性。结果本次评价共收集到云南省3个地区4个不同人群的500份样本,经抗体、核酸和随访后检测,314份(62.80%)确定为HIV感染。评价试剂的特异性为100.00%(186/186),敏感性为98.41%(309/314)。评价试剂和对比试剂均能100%检出HIVgp160条带。评价试剂HIVgp41条带检出率为99.68%,显著高于确证对比试剂92.68%(χ^(2)=19.11,Ρ<0.05)。结论该试剂适用于HIV抗体检测,但临床应用中的检验效能还有待进一步验证。
Objective To evaluate the value and quality of a rapid HIV antibody confirmatory reagent in clinical application.Methods According to the detection process,screening and confirmatory testing were carried out,and the conformance between the evaluation reagent and the contrast reagent was analyzed and evaluated.The sensitivity and specificity of the evaluation reagent in the diagnosis of HIV infection were counted.Results A total of 500 samples were collected and tested in this evaluation from 4 different populations in 3 regions of Yunnan Province.Through antibody,nucleic acid and follow-up tests,186 samples(37.20%)were negative for HIV antibody,and 314 samples(62.80%)were HIV infected.The specificity of the evaluation reagent was 100%(186/186),and the sensitivity was 98.41%(309/314).The HIVgp160 bands could be detected 100%by the evaluation reagent and the contrast reagent.The detection rate of HIVgp41 was 99.60%,which was significantly higher than that of 92.68%(χ^(2)=19.11,Ρ<0.05).Conclusion The reagent is suitable for HIV antibody detection,but its efficacy in clinical application remains to be further verified.
作者
陈会超
董莉娟
戴洁
金晓媚
杨敏
曾志君
孙鹏艳
杨莉
杨朝军
陈敏
CHEN Huichao;DONG Lijuan;DAI Jie;JIN Xiaomei;YANG Min;ZENG Zhijun;SUN Pengyan;YANG Li;YANG Chaojun;CHEN Min(Institute for AIDS/STDs Control and Prevention,Yunnan Provincial Center for Disease Control and Prevention,Kunming 650022,China)
出处
《中国艾滋病性病》
CAS
CSCD
北大核心
2022年第1期67-69,共3页
Chinese Journal of Aids & STD
基金
国家科技重大专项(2018ZX10715-006)。
