新型冠状病毒核酸检测中的思维误区

目的探讨2019新型冠状病毒(2019-nCoV)核酸检测在目前新型冠状病毒肺炎(COVID-19)病例确诊中遇到的"假阴性"和"假阳性"问题。方法根据2019-nCoV核酸检测的基本原理和条件,从检测样本采集、运输、保存的方式,试剂盒的质量,以及临床实验室的管理等多方面,分析2019-nCoV核酸检测报告"假阴性"和"假阳性"的原因。结果研究结果论述了造成当前2019-nCoV核酸检测"假阴性"和"假阳性"的可能原因。优化样本采集的操作和方法,加强质控管理,开发应用新技术,加强对疑似病例和出院患者的诊断和管理,是避免2019-nCoV核酸检测报告出现"假阴性"的应对策略,并对保证核酸检测结果的及时性和准确性具有非常重大的意义,可供相关部门在制定防治策略和开展工作时参考。结论核酸检测阳性结果被视为2019-nCoV感染诊断的金标准,而阴性结果不能作为排除2019-nCoV感染的金标准,更不能作为排除COVID-19的金标准。

Misunderstanding of nucleic acid testing for 2019-nCoV

OBJECTIVE To explore the problems such as ’false negative’ and ’false positive’ in nucleic acid test for 2019-nCoV during the diagnosis of Corona Virus Disease 2019(COVID-19). METHODS The causes of ’false negative’ and ’false positive’ for 2019-nCoV nucleic acid tests were analyzed on the basis of basic principles and conditions of 2019-nCoV nucleic acid test, involving the means of collection, delivery and storage of samples, quality of kit and management of clinical laboratories. RESULTS The possible causes of the ’false negative’ and ’false positive’ for 2019-nCoV nucleic acid tests were discussed. The optimization of procedures of sample collection, enhancement of quality control management, development and application of new technology and enhancement of diagnosis and management of suspected and discharged cases were the coping strategies for avoiding the ’false negative’ 2019-nCoV nucleic acid test, which have great significance in assuring the timely and accurate result of nucleic acid test and provide related departments with the reference in formulating prevention and treatment strategies.CONCLUSION The positive nucleic acid test is considered as the gold standard for diagnosis of 2019-nCoV infection, while the negative nucleic acid test can neither be taken as the gold standard for exclusion of 2019-nCoV infection nor the gold standard for exclusion of COVID-19.