新冠病毒抗体ELISA筛查假阳性反应:不同方法检测结果的内在逻辑  

False positive reaction of COVID-19 antibody ELISA screening:internal logic of various methods

作　　者：王立林[1] 李然 李彤[1] 张爱佳 刘衡[1] 许晓绚[1] 曾劲峰[1] 邬林枫[1] WANG Lilin;LI Ran;LI Tong;ZHANG Aijia;LIU Heng;XU Xiaoxuan;ZENG Jinfeng;WU Linfeng(Shenzhen Blood Center,Shenzhen 518000,China.)

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国输血杂志》2023年第12期1085-1089,共5页Chinese Journal of Blood Transfusion

基　　金：2020年度广东省医学基金项目(A2020259);深圳市医学重点学科建设经费(SZXK070);深圳市医疗卫生三名工程项目(SZSM2023028);深圳市血液中心科研课题(SZBC202202)。

摘　　要：目的在无偿献血人群中,分析新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)酶联免疫吸附试验(enzyme linked immunosorbnent assay,ELISA)抗体筛查出的反应性标本采用不同检测方法的检测结果。方法对2020年3—4月,深圳地区8632人次献血者血浆中ELISA筛查出SARS-CoV-2总抗体(total antibody,TAb,包括IgG、IgM、IgA)阳性标本(PC组)及其追踪血浆标本(FC组),2020年1—4月疾病对照标本(DC组)采用以下方法检测:(1)ELISA方法检测IgG,IgM和(或不用检测)TAb;(2)假病毒中和抗体试验(pVNT);(3)SARS-CoV-2抗体免疫印迹试验(Western Blot,WB)。2020年2—4月阴性对照标本(NC组),采用ELISA和WB方法检测。结果34例总抗体阳性标本中,2例pVNT试验阳性、初次筛查标本和追踪标本总抗体和IgG均阳性,WB结果阳性,判定为确证阳性;其余2例pVNT试验阳性,WB结果阳性的标本在追踪随访阶段,总抗体、IgG及pVNT结果不符合抗体演变规律,尚不能判定为确证阳性。结论新型冠状病毒ELISA筛查抗体反应性标本感染状态可综合pVNT、WB和追踪标本抗体动态变化的逻辑进行判断。Objective To analyze the results of different methods for reactive samples screened by the enzyme linked immunosorbent assay(ELISA)against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)in blood donors.Methods From March to April 2020,a total of 8632 blood samples in Shenzhen were screened for SARS-CoV-2 total antibodies(TAb,including IgG,IgM,IgA)in plasma using ELISA(PC group),the antibody reactivity samples and their follow up plasma samples(FC group),and samples of disease control group(DC group)from January to April 2020 were detected using the following methods:(1)ELISA method for detecting IgG,IgM,and(or without detection)TAb;(2)pseudovirus neutralizing antibody test(pVNT);(3)western blot(WB)of SARS-CoV-2 antibody.The negative control group(NC group)from February to April 2020 performed ELISA and WB testing.Results Among the 34 total antibody positive samples,2 were positive for pVNT test,and the total antibody,IgG and WB in the initial screening and tracking testing were positive.Thereafter,it was determined to be confirmed positive.The other 2 cases were positive for pVNT test,while the samples with positive WB results were in the follow-up stage.The TAb,IgG,and pVNT results did not conform to the dynamic evolution of antibodies,and cannot be determined as confirmed positive.Conclusion The infection status of antibody reactivity samples screened by SARS-CoV-2 ELISA can be judged by the logic of pVNT,WB and the dynamic change of antibody.

关 键 词：新型冠状病毒 反应性标本 假病毒中和抗体试验 免疫印迹试验 动态监测 

分 类 号：R446[医药卫生—诊断学]