WB抗体不确定/阴性受检者HIV-1-RNA检测结果分析  

Analysis of HIV-1-RNA test results of WB antibody uncertainty/negative subjects

作　　者：李梅[1] 袁薇 葛章文 杨敬源[1] 刘勇 张淑俊 赵强[2] LI Mei;YUAN Wei;GE Zhangwen;YANG Jingyuan;LIU Yong;ZHANG Shujun;ZHAO Qiang(School of Public Health,Guizhou Medical University,Guiyang 550025,China;不详)

机构地区：[1]贵州医科大学公共卫生与健康学院,贵阳550025 [2]贵州省临床检验中心检验检测科 [3]贵州省人民医院检验科

出　　处：《医学动物防制》2023年第6期517-521,共5页Journal of Medical Pest Control

基　　金：国家自然科学基金(82260658);贵州省卫健委科技基金项目(gzwjkj2020-1-198)。

摘　　要：目的探讨核酸定量检测对诊断HIV-1抗体不确定/阴性受检者感染的临床应用价值。方法收集贵州省3市2021年1月—10月艾滋病初筛实验室进行的筛查实验(酶联免疫吸附法、化学发光和快速检测法)且抗体有反应性的受检者进行免疫印迹法(western blotting,WB),对WB检测结果为HIV-1抗体不确定/阴性受检者进行随访追踪并增加核酸定量检测作为补充实验,后将初筛试验结果、WB试验结果及核酸定量检测结果纳入统计分析。结果3800例初筛有反应性的受检者经过WB确证为抗体阳性占76.9%、抗体阴性占6.6%、抗体不确定占16.4%。876例WB抗体不确定及阴性受检者核酸定量检测分布显示,病毒载量(viral load,VL)>5000copies/ml有175例,占20.0%;VL水平在250~5000copies/ml有4例,占0.5%;低于检测下限6例,占0.7%;未检出691例,占78.9%。初筛试验不同检测方法间与VL阳性率有明显差异,快速检测法和VL阳性符合率最低,占12.1%,酶联免疫吸附试验(enzyme linked immunosorbent assay,ELISA)占比最高,为25.0%,ELISA随S/CO升高,VL阳性率逐步升高。随访的87例受检者,19例VL>5000copies/ml的受检者WB抗体全部转阳,2例VL为250~5000copies/ml的受检者随访WB抗体转阳,其余未检出的受检者WB抗体全部转阴,核酸定量检测结果与随访诊断结果的一致性较好(Kappa=0.935,P<0.01),总体符合率为97.7%(85/87)。结论筛查试验S/CO值在一定程度上为及时诊断HIV-1感染提供参考依据,核酸定量检测有助于WB抗体不确定/阴性的及时诊断,且经VL诊断的HIV-1感染者体内病毒载量值较高。Objective To explore the clinical value of the quantitative nucleic acid test in the diagnosis of HIV-1 antibody infection in uncertain/negative subjects.Methods The subjects with antibody reactivity in screening tests(ELISA,CLIA,and RT)conducted in preliminary HIV screening laboratories in three cities of Guizhou Province from January to October 2021 were collected for the western blotting(WB).The subjects with WB results as HIV-1 antibody uncertainty/negative were followed up and the quantitative nucleic acid test was added as a supplementary experiment,and the results of the initial screening test,the results of the WB,and the results of the quantitative nucleic acid test were included in the statistical analysis.Results Three thousand and eight hundred initially screened reactive subjects were confirmed as antibody positive by WB,accounting for 76.9%,negative for 6.6%,and uncertain for 16.4%.The quantitative nucleic acid distribution of 876 cases of WB antibody uncertainty and negative subjects showed that there were 175 cases with viral load(VL)>5000copies/ml,accounting for 20.0%,4 cases with VL level of 250-5000copies/ml,accounting for 0.5%,6 cases(0.7%)were lower than the lower limit of detection,and 691 cases with no target detected,accounting for 78.9%.The positive rate of VL was significantly different between different detection methods in the preliminary screening test.The coincidence rate of the rapid detection method and VL was the lowest,accounting for 12.1%,and that of the ELISA was the highest,accounting for 25.0%.The positive rate of VL gradually increased with the increase of S/CO by ELISA.A total of 87 subjects were followed up,19 cases with VL>5000copies/ml WB antibody all turned positive,two cases of VL turned positive during the follow-up of WB antibody in 250-5000copies/ml subjects,and the rest with undetected WB antibody turned negative.The results of the quantitative nucleic acid test and follow-up diagnosis were consistent(kappa=0.935,P<0.01),and the overall compliance rate was 97.7%(85

关 键 词：免疫印迹法 核酸定量检测 抗体不确定/阴性 早期诊断 筛选试验 实验室诊断 

分 类 号：R512.91[医药卫生—内科学]