三种化学发光免疫分析法人类免疫缺陷病毒抗原抗体筛查试剂的临床评价

Clinical evaluation of three chemiluminescence immunoassays for human immunodeficiency virus antigen and antibody screening

目的以罗氏E170电化学发光法和迈克IS1200间接化学发光法为对比,对迈克i3000直接化学发光法人类免疫缺陷病毒(human immunodeficiency virus,HIV)抗原抗体检测试剂进行临床评价。方法采用10个HIV-1血清转换盘及2017年4月-12月四川大学华西医院11例单独p24抗原阳性标本进行分析灵敏度评价;收集2017年4月-12月四川大学华西医院送检HIV抗原抗体检测样本350例,其中200例为确证HIV-1阳性样本,150例为HIV 1+2阴性样本,另有1例购买的HIV-2阳性标本,共351例样本进行一致性评价;对2017年4月-12月四川大学华西医院98例可能干扰HIV检测标本行干扰性评价。结果分析灵敏度评价中,对于10个血清转换盘的63个检测样本,罗氏E170共检测出25个,迈克i3000共检测出23个,迈克IS1200共检测出22个;对于11例单独p24抗原阳性标本,迈克i3000与罗氏E170均检出11例阳性,而IS1200系统检出10例阳性。一致性评价中,迈克i3000与罗氏E170、迈克IS1200均具有很好的一致性(kappa>0.9,P<0.001)。干扰性评价中,迈克i3000存在假阳性,分别为1例类风湿关节炎和1例梅毒阳性标本。结论迈克i3000直接发光试剂除高通量和良好的一致性之外,灵敏度较高,窗口期较短,能够满足临床的需求。

Objective To evaluate the performance of i3000 direct chemiluminescence detection of human immunodeficiency virus(HIV)antigen and antibody(Ag/Ab)screening assay(Maccura),compared with E170electrochemiluminescence method(Roche,Elecsys?HIV Combi PT assay)and IS1200 indirect chemiluminescence method(Maccura).Methods Ten HIV seroconversion panels and 11 p24 antigen positive samples from West China Hospital of Sichuan University from April to December 2017 were used to evaluate the sensitivity of those three assays.A total of 351 samples were collected for consistency evaluation,including 350 HIV Ag/Ab test samples(200 HIV-1positive plasma samples and 150 HIV 1+2 negative plasma samples)from West China Hospital of Sichuan University from April to December 2017,and one commercial HIV-2 sera.A total of 98 interfere samples for HIV testing were collected from West China Hospital of Sichuan University from April to December 2017.Results In the sensitivity evaluation,there were 63 samples from the 10 seroconversion panels,in which Roche E170 detected 25 samples,Maccura i3000 detected 23 samples,and Maccura IS1200 detected 22 samples;Maccura i3000 and Roche E170 assays detected all the p24 antigen positive samples(11,100%),while Maccura IS1200 only detected 10 samples.In the consistency evaluation,Maccura i3000 had nice consistency with both Roche E170 and Maccura IS1200(kappa>0.9,P<0.001).In the interference evaluation,there were two false positives in Maccura i3000 detection,one case of rheumatoid arthritis and one case of syphilis.Conclusion In addition to high throughput and good consistency,Maccura i3000 direct chemiluminescence reagent has high sensitivity and a short window period,which can meet clinical needs.