HIV区分抗原抗体筛查电化学发光免疫分析法在普通人群中的临床应用研究

Clinical application of electrochemiluminescence immunoassay for screening HIV differentiated antigen and antibody in the general population

目的探讨HIV区分抗原抗体筛查电化学发光免疫分析法(electrochemiluminescent immunoassay,ECLIA)在普通人群中的临床应用效果,为HIV诊断策略的应用提供数据支撑。方法收集2020年9月至2021年4月首都医科大学附属北京佑安医院普通门诊或住院手术/有创诊疗前接受HIV抗原抗体ECLIA筛查的13745例患者的检测结果,比较不同抗原抗体反应模式的结果与补充实验结果的一致性,以及与HIV-1核酸定量之间的关系。结果HIV区分抗原、抗体筛查阳性106例,最终补充实验阳性符合率为73.6%(78/106),其中单独抗原阳性15例、抗原和抗体均阳性33例、单独抗体阳性58例,补充实验阳性符合率分别为0.0%(0/15)、81.8%(27/33)和87.9%(51/58);抗原和抗体均阳性的补充实验阳性符合率低于单独抗体阳性,差异有统计学意义(χ^(2)=47.72,P<0.01);抗原和抗体均有反应病例采用蛋白印迹法(western blotting,WB)确证12例,结果均为阳性,其中p31条带阳性率为58.3%(7/12);单独抗体有反应病例采用WB确证25例,结果均为阳性,其中p31条带阳性率为100.0%(25/25);两种抗原抗体反应模式经WB确证带型中p31条带阳性率比较,差异有统计学意义(χ^(2)=12.04,P<0.01);按补充实验结果将筛查有反应病例分为两组,阳性组抗体COI值[340.50(78.15,960.75)比2.20(0.43,5.51)]显著高于阴性组,差异有统计学意义(Z=5.70,P=0.00)。结论在普通人群中对HIV区分抗原抗体筛查ECLIA单独抗原阳性结果与补充实验符合率低,对HIV早期感染的预测作用有限。

Objective To investigate the clinical effect of electrochemiluminescent immunoassay(ECLIA)for HIV differentiated antigen and antibody in the general population,and to provide data support for the application of HIV diagnosis strategies.Methods From September 2020 to April 2021,13745 patients of general outpatient department or inpatient underwent surgery or invasive treatment in Beijing Youan Hospital,Capital Medical University who underwent HIV antigen and antibody ECLIA screening were enrolled.The results of differentiated antigen and antibody response patterns were compared with the results of supplementary experiments,and the HIV-1 nucleic acid quantification.Results A total of 106 cases were positive for HIV differentiated antigen and antibody screening,and the positive coincidence rate of the final supplementary test was 73.6%(78/106),including 15 cases of single antigen positive,33 cases of both antigen and antibody positive,58 cases of single antibody positive.The positive coincidence rate of supplementary test was 0.0%(0/15),81.8%(27/33)and 87.9%(51/58),respectively.The positive coincidence rate of supplement test with positive antigen and antibody was lower than that of single antibody positive,the difference was statistically significant(χ^(2)=47.72,P<0.01).Western blotting(WB)was used to confirm 12 cases of both antigen and antibody reaction,and all of them were positive,among which the positive rate of p31 band was 58.3%(7/12).WB was used to confirm 25 cases of antibody response alone,and all of them were positive,among which the positive rate of p31 band was 100.0%(25/25).There was significant difference in the positive rate of p31 band between the two antigen antibody reaction modes confirmed by WB(χ^(2)=12.04,P<0.01).According to the results of supplementary test,the screened patients were divided into two groups.The antibody COI value[340.50(78.15,960.75)vs.2.20(0.43,5.51)]in the positive group was significantly higher than that in the negative group,the difference was statistically significant(Z=5.70,P=0.00).Conclusions In the general population,the ECLIA for HIV differentiated antigen and antibody detection has a low conformity rate between the positive screening results of single antigen and the supplementary test,and has a limited role in predicting the early HIV infection.