免疫层析法检测2019新型冠状病毒抗体假阳性的原因分析和对策  

Cause Analysis and Countermeasures of False Positive Detection of 2019 Novel Coronavirus Antibody by Immunochromatography

作　　者：刘奕彦 叶青[1] LIU Yiyan;YE Qing(The Children's Hospital of Zhejiang Unitversity School of Medicine,National Clinical Research Center for Child Health,Hangzhou310052,China)

机构地区：[1]浙江大学医学院附属儿童医院国家儿童健康与疾病临床医学研究中心,杭州310052

出　　处：《病毒学报》2021年第3期712-718,共7页Chinese Journal of Virology

基　　金：浙江省卫生科技项目计划省部级共建重点项目(WKJ-ZJ-2128)。

摘　　要：2019年12月,新型冠状病毒(SARS-CoV-2)首次被发现并很快引起全球大流行,SARS-CoV-2感染的早期诊断对疫情防控至关重要。胶体金免疫层析法检测SARS-CoV-2抗体是诊断新型冠状病毒肺炎的重要标准之一。该方法具有操作简便,报告快速,不需要仪器设备等优点。然而,该方法也存在假阳性较多的问题,给临床诊断带来了很大的困惑。本文分析和总结了在临床中采用胶体金免疫层析法检测SARS-CoV-2抗体产生假阳性的原因。结果表明最为常见的内源性干扰包括类风湿因子、嗜异性抗体、人抗动物抗体、溶菌酶、补体和交叉抗原。外源性干扰主要为标本凝固不全,标本污染和试剂盒反应体系优化不足。内源性干扰可以通过稀释、封闭和酶切等方法降低非特异性结合来减轻;消除外源性干扰需操作者严格按照实验室操作规程规范操作。此外,将兔抗μ链和/或γ链抗体F(ab’)2作为固相载体的包被抗体,采用含非特异性兔IgG的Buffer,也能有效降低内源性干扰物造成的假阳性。In December 2019,a new type of coronavirus(SARS-CoV-2)was discovered for the first time and soon caused a global pandemic.Early diagnosis of SARS-CoV-2 infection is very important for epidemic prevention and control.The detection of SARS-CoV-2 antibodies by colloidal gold immunochromatography is one of the important criteria for the diagnosis of COVID-19.This method has the advantages of simple operation,fast reporting,and no need for equipment.However,this method also has the problem of more false positives.This problem has brought great confusion to clinical diagnosis.This article analyzes and summarizes the causes of false-positive detection of SARS-CoV-2 antibodies by colloidal gold immunochromatography in clinical practice.The results indicate that the most common endogenous interferences include rheumatoid factor,heterophile antibodies,human anti-animal antibodies,lysozyme,complement and cross-antigens.The exogenous interference is mainly incomplete coagulation of the specimen,contamination of the specimen and insufficient optimization of the reaction system of the kit.Endogenous interference can be mitigated by reducing non-specific binding by dilution,blocking,and restriction digestion;eliminating exogenous interference requires operators to strictly follow laboratory operating procedures.In addition,using rabbit anti-μchain and/orγchain antibody F(ab’)2 as a solid-phase carrier coating antibody,and using a buffer containing non-specific rabbit IgG,can also effectively reduce the endogenous interference caused by False positive.

关 键 词：2019新型冠状病毒 免疫层析 特异性抗体 假阳性 

分 类 号：R373.9[医药卫生—病原生物学]