张月娟, 倪争鸣, 王娜, 刘效峰, 王成义, 郁晓磊. 艾滋病筛检人群HIV-1抗体确证阳性率分析[J]. 上海预防医学, 2019, 31(6): 514-519. DOI: 10.19428/j.cnki.sjpm.2019.19383
引用本文: 张月娟, 倪争鸣, 王娜, 刘效峰, 王成义, 郁晓磊. 艾滋病筛检人群HIV-1抗体确证阳性率分析[J]. 上海预防医学, 2019, 31(6): 514-519. DOI: 10.19428/j.cnki.sjpm.2019.19383
ZHANG Yue-juan, NI Zheng-ming, WANG Na, LIU Xiao-feng, WANG Cheng-yi, YU Xiao-lei. Positive rate analysis on HIV-1 antibody confirmation in AIDS screening population[J]. Shanghai Journal of Preventive Medicine, 2019, 31(6): 514-519. DOI: 10.19428/j.cnki.sjpm.2019.19383
Citation: ZHANG Yue-juan, NI Zheng-ming, WANG Na, LIU Xiao-feng, WANG Cheng-yi, YU Xiao-lei. Positive rate analysis on HIV-1 antibody confirmation in AIDS screening population[J]. Shanghai Journal of Preventive Medicine, 2019, 31(6): 514-519. DOI: 10.19428/j.cnki.sjpm.2019.19383

艾滋病筛检人群HIV-1抗体确证阳性率分析

Positive rate analysis on HIV-1 antibody confirmation in AIDS screening population

  • 摘要:
    目的对人类免疫缺陷病毒(HIV)抗体筛查有反应样本与HIV-1抗体确证阳性结果进行对比分析,探讨筛查检测与确证检测结果的符合性。
    方法根据中国疾病预防控制中心《全国艾滋病检测技术规范》(2015版),对2017年12月—2018年12月上海市宝山区289份酶联免疫吸附试验(ELISA)、免疫渗透/层析试验HIV筛查有反应标本(其中ELISA试验286份,免疫渗透/层析试验276份)和70份化学发光法筛查有反应,但ELISA、免疫渗透/层析试验均为阴性标本,采用免疫蛋白印迹试验(WB)进行确证,并对筛查和确证结果进行对比分析。
    结果经WB确证试验显示,289份ELISA、免疫渗透/层析试验初筛有反应样品中,HIV-1抗体阳性245份(84.78%),不确定34份(11.76%),阴性10份(3.46%)。ELISA、免疫渗透/层析试验与WB确证试验结果的符合率分别为85.66%(245/286)和88.77% (245/276),二者差异无统计学意义(χ2=1.211,P=0.271)。WB确证试验HIV-1抗体阳性、不确定及阴性的平均S/c.o值分别为(24.66±1.37)、(20.15±8.06)和(7.96±8.40),三组间差异有统计学意义(F=137.96,P=0.000)。289份筛查有反应样本中,9份样本的S/c.o值在1~6之间,确证阳性1份,阳性符合率为11.11%;3份样本的S/c.o值7~10之间,确证阳性2份,阳性符合率为66.67%;277份样本的S/c.o值均大于10,确证阳性242份,阳性符合率为87.36%。HIV-1抗体确证阳性的样本中,gp160、gp120、gp41、p66、p24条带同时出现的概率为95%。70份化学发光法HIV筛查有反应,ELISA、免疫渗透/层析试验阴性标本中,WB确证结果阴性无条带36份,占51.43%(36/70),出现1条带27份,占38.57%(27/70),出现2条带7份,占10%(7/70)。
    结论HIV筛查采用敏感性、特异性高的试剂,即抗原抗体同时检测,即可减少感染早期漏检,也可提高与确证结果的符合性。筛查试验因样本或某些疾病的影响,存在假阳性可能,必须以抗体确证或核酸补充试验结果为准。HIV抗体确证试验,因其检测的抗体出现较晚,对早期感染者存在漏检风险,建议对初筛有反应S/c.o值较低(1~6之间),抗体确证试验阴性或不确定者,以及化学发光法HIV筛查有反应,ELISA、免疫渗透/层析试验阴性者,采用核酸补充试验检测或结合流行病学资料进行进一步随访。

     

    Abstract:
    ObjectiveTo compare and analyze the positive samples of human immunodeficiency virus (HIV) antibody screening and immunoblotting tests (WB), and to explore the conformity of the results of screening test and WB confirmation.
    MethodsAccording to the requirements of National AIDS Testing Technical Specification (2015 edition) of China Center for Disease Control and Prevention, 289 HIV screening test positive samples in Baoshan District of Shanghai from December 2017 to December 2018 were confirmed by WB method, and the results of screening and confirmation were compared and analyzed.Of them, 286 were ELISA positive, 276 immunoosmosis/chromatography positive and 70 samples of chemiluminescence positive.Both ELISA and immunoosmosis/chromatography tests were negative.The negative samples of ELISA and immunoosmosis/chromatography were detected by immunoblotting (WB).
    ResultsOf 289 HIV screening test positive samples, 245 (84.78%) were HIV-1 positive, 34 (11.76%) uncertain and 10 (3.46%) negative.The coincidence rates of ELISA, IMC and WB were 85.66% (245/286) and 88.77% (245/276), respectively.There was no significant difference between them (χ2=1.211, P=0.271).The average S/c.o values of positive, uncertain and negative HIV-1 antibodies in WB confirmation test were (24.66±1.37), (20.15±8.06) and (7.96±8.40), respectively.There were significant differences among the three groups (F=137.96, P=0.000).Among 289 screening test positive samples, the S/c.o values of 9 samples were between 1 and 6, and the positive coincidence rate was 11.11%.The S/c.o values of 3 samples were between 7 and 10, and the positive coincidence rate of 2 samples was 66.67%.The S/c.o values of the other 277 samples were all over 10.Of 242 samples were confirmed positive, and the rate of positive coincidence was 87.36%.In HIV-1 positive samples, the probability of simultaneous occurrence of gp160, gp120, gp41, p66 and p24 bands was 95%.Of 70 HIV screening responded positive by chemiluminescent method.In ELISA and immunoosmosis/chromatography negative samples, 51.43% (36/70) were negative by WB; 38.57% (27/70) were one band; 10% (7/70) were two bands.
    ConclusionHIV screening should be used of highly sensitive and specific reagent, namely antigen and antibody detection at the same time, which can reduce the early missed screening of infection and improve the coincidence with the confirmation results.Because of the influence of samples or certain diseases, false positivity may exist in screening tests, which must be based on the results of antibody confirmation or nucleic acid supplementation tests.HIV antibody confirmation tests, because of the late occurrence of IgG antibodies detected, have the risk of missed screening for early infected persons.It is suggested that there should be a counter-reaction to the initial screening.Those with low S/c.o values (between 1 and 6), negative or uncertain antibody confirmation tests, responding to chemiluminescent HIV screening, negative samples from ELISA and immunoosmosis/chromatography tests, should be followed up by nucleic acid supplementation test or by combination check with epidemiological data.

     

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