核酸检测在HIV检测策略中的应用探讨  

Application of nucleic acid detection in HIV testing algorithm

作　　者：毛旭建 许健 周嘉晟 陈抒蕾[1] 蒋靖怡 姚萍[1] 李琼[1] 王凤鸣[1] 唐宏兵[1] 黎俊宏[1] MAO Xujian;XU Jian;ZHOU Jiasheng;CHEN Shulei;JIANG Jingyi;YAO Ping;LI Qiong;WANG Fengming;TANG Hongbing;LI Junhong(Changzhou Center for Disease Control and Prevention,Changzhou 213022,Jiangsu,China;School of Public Health of Nantong University,Nantong 226004,Jiangsu)

机构地区：[1]常州市疾病预防控制中心,江苏常州213022 [2]南通大学公共卫生学院,江苏南通226004

出　　处：《中国艾滋病性病》2023年第1期14-18,共5页Chinese Journal of Aids & STD

基　　金：常州市卫生健康青苗人才培养工程资助(CZQM2020113);常州市科技应用基础研究计划(CJ20200105,CJ20210100,CJ20210073);常州市病原生物学重点实验室(CM20223016)。

摘　　要：目的分析本地区HIV待确证样本核酸检测和WB结果,探讨核酸检测在HIV检测策略中的应用。方法收集常州市2019-2021年共1382份HIV待确证样本,在获得WB确证(包括随访后)结果后进行核酸检测,通过比较两种方法的检测结果分析不同检测策略的灵敏度、特异性和符合率。结果1382份HIV待确证样本出具了1073份HIV-1抗体阳性报告,165份HIV-1抗体不确定报告,144份HIV-1抗体阴性报告。1073份抗体阳性样本核酸检出率为96.37%(1034/1073),165份抗体不确定样本核酸检出率为32.12%(53/165),144份抗体阴性样本检出2例高病毒载量样本。抗体不确定样本随访率33.94%(56/165),核酸检出率和随访抗体阳性率单条带样本分别为20.54%(23/112)和27.59%(8/29),双条带样本为52.08%(25/48)和72.73%(16/22),三条带样本均为100.00%(5/5)。含p24条带样本分别为64.15%(34/53)和65.52%(19/29)。补充实验检测策略分别采用先抗体确证再随访、先抗体确证再核酸检测和先核酸检测再抗体确证的灵敏度为98.39%(1102/1120)、100.00%(1120/1120)和86.34%(967/1120),特异性为62.60%(159/254)、99.61%(253/254)和99.61%(253/254),符合率为91.78%(1261/1374)、99.93%(1373/1374)和88.79%(1220/1374)。结论HIV核酸检测可以提高抗体不确定样本的阳性发现率,并避免抗体阴性样本漏检,应用抗体确证再核酸检测的检测策略具有最佳的灵敏度、特异性和符合率。Objective To analyze the results of nucleic acid testing and Western blot(WB)of HIV unconfirmed samples in the region and to explore the application of nucleic acid testing in the HIV testing algorithm.Methods A total of 1382 HIV unconfirmed samples in Changzhou from 2019 to 2021 were collected.Nucleic acid detection was performed after WB confirmation(including follow-up).The sensitivity,specificity and coincidence rate of the different testing algorithms were analyzed by comparing the detection results of the two methods.Results 1382 HIV unconfirmed samples issued 1073 HIV-1 antibody-positive reports,165 HIV-1 antibody-indeterminate reports and 144 HIV-1 antibodynegative reports.The detectable rate of nucleic acid was 96.37%(1034/1073)from 1073 antibody-positive samples and 32.12%(53/165)from 165 antibody-indeterminate samples.Two high viral load samples were detected in 144 antibodynegative samples.The follow-up rate was 33.94%(56/165).The detectable rate of nucleic acid and follow-up antibody positivity rates were 20.54%(23/112)and 27.59%(8/29)for single-band samples,52.08%(25/48)and 72.73%(16/22)for double-band samples and 100%(5/5)for all three bands,respectively.Samples containing p24 band were 64.15%(34/53)and 65.52%(19/29),respectively.The sensitivity of the supplemental experimental testing algorithm of antibody confirmation followed by followup,antibody confirmation followed by nucleic acid detection,and nucleic acid detection followed by antibody confirmation was 98.39%(1102/1120),100%(1120/1120)and 86.34%(967/1120).The specificity was 62.60%(159/254),99.61%(253/254)and 99.61%(253/254),respectively.The coincidence rate was 91.78%(1261/1374),99.93%(1373/1374),and 88.79%(1220/1374).Conclusions HIV nucleic acid detection can improve the positive detection rate of antibody-indeterminate samples and avoids leak detection in antibody-negative samples.The detection strategy of antibody confirmation followed by nucleic acid detection has the best sensitivity,specificity,and coincidence rate.

关 键 词：艾滋病病毒 核酸检测 蛋白印迹 随访 检测策略 

分 类 号：R373.9[医药卫生—病原生物学]