新型冠状病毒核酸检测假阴性原因分析及控制要点

Cause analysis and control points of false negative nucleic acid test for severe acute respiratory syndrome coronavirus 2

新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)疫情自发生以来引起了国内外的强烈关注,并造成了巨大的医疗资源负担和社会经济损失.各研究单位积极响应,相继研发出新型冠状病毒(SARS-CoV-2)核酸检测产品,并因其灵敏度高、特异性好、可重复性佳等原因而成为COVID-19确诊的重要依据.然而当前临床检验中却不断暴露出核酸检测假阴性偏高的问题,原因可能涉及核酸检测实验各个环节,如样本采集、检测试剂质量等诸多方面.因此,本文针对当前SARS-CoV-2核酸检测假阴性问题的可能原因进行分析,并阐述核酸检测过程中的质量控制要点,以期提高核酸检测阳性率,为疫情防控提供更加可靠的科学依据.

Since the outbreak of the coronavirus disease 2019(COVID-19),it has aroused strong attention worldwide,and has caused a huge burden on medical resources and socioeconomic losses.Various research units actively responded and successively developed nucleic acid detection products for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).Because of its high sensitivity,specificity and reproducibility,nucleic acid detection has become an important basis for the diagnosis of COVID-19.However,the problem of high frequency of false negative in nucleic acid detection was exposed in clinical tests,and the cause may involve various aspects of the nucleic acid detection experiments,such as sample collection,quality of test reagents,and many others.Therefore,in this article we analyze possible causes of the false negative problem in current SARS-CoV-2 nucleic acid detections,and comprehensively explain the quality control points in the nucleic acid detection process,in order to improve the rate of positive nucleic acid detection and provide a more reliable scientific basis for epidemic prevention and control.