新型冠状病毒肺炎核酸检测中的假阴性分析及对策

新型冠状病毒肺炎(COVID-19)的疫情引发了全世界的关注。早期诊断对COVID-19的治疗、患者预后尤为关键。临床检验中发现早期的COVID-19患者核酸检测多次呈假阴性,特别是不同时间多次阴性结果后转为阳性,给临床诊断和疾病控制带来极大困扰。该文立足于疫情的早日防控,从临床、检验的不同视角,从标本采集、检测方法、产品稳定性等多方面剖析产生假阴性的可能原因,并且结合临床实践和检测技术,从整合特异性实验室指标,规范标本采集方式和过程,严格检测试剂的监管和审批等方面提出行之有效的方案,旨在为切实降低检测假阴性或假阳性率提供临床参考,为COVID-19临床准确诊断及疫情防控提供有力支撑。

Preventing false negative results in detecting new coronavirus nucleic acid

The outbreak of new coronavirus pneumonia(COVID-19)has caused worldwide concern.Early diagnosis is particularly critical for the treatment of COVID-19 and prognosis.Clinical applications indicated that false-negative results have been frequently reported during the nucleic acid detection for patients with COVID-19 in the early stage,and then the results turned positive after multiple negative results at different times,causing great distress to clinical diagnosis and disease control.Based on the epidemic situation and early prevention and control,this article analyzed the possible causes of false negatives from various aspects of clinic and laboratory,including specimen collection,testing methods,product stability,and other aspects.Then we put forward effective solutions for COVID-19 pandemic prevention,such as combining clinical practice with laboratory detection technologies of specific biomarkers,employing standard specimen collection methods and processes,providing strict supervision and approval of diagnostic reagents.These measures provide clinical references for effectively reducing false negative or false positive detection rate,and provide strong support for the accurate clinical diagnosis and epidemic prevention and control of COVID-19.