新型冠状病毒血清特异性抗体检测的假性问题分析和对策探讨

SARS-CoV-2 Serological Antibody Testing:Problems of False Detections and the Solutions

新型冠状病毒肺炎对全球造成了巨大威胁。目前血清抗体检测,成为该疾病诊断和流行控制的关键指标。我国“新型冠状病毒肺炎诊疗方案(试行第七版)”中,已明确将新型冠状病毒抗体检测作为临床确诊标准。在临床实际工作过程中,笔者发现新型冠状病毒抗体检测存在着假阳性或者假阴性的问题,给临床解读造成困扰。该文针对新型冠状病毒抗体检测方法的设计和原理,分析可造成假阳性和假阴性结果的原因,并指出解决方法,从而促进对新冠病毒抗体检测更好的理解,以及为临床提供更加全面的结果解读。

The novel coronavirus pneumonia(COVID-19)outbreak has caused a global disaster.Currently,the antibody testing has become the key for controlling of this pandemic.The guidelines from the National Health Commission(trial version 7)recommend the antibody(IgM and IgG)testing for the COVID-19 diagnosis and therapy.However,false positive and negative detections are often found in clinical laboratories.The author therefore here discuss the possible reasons and solutions of the questionable results,based on the designs and priciples of the immunoassays developed for the COVID-19 antibody detection.This review will facilitate better understanding of the COVID-19 antibody detection and more appropriate interpretation of the results for clinicians.