新型冠状病毒核酸检测试剂的发展现状

Development status of nucleic acid testing for severe acute respiratory syndrome coronavirus 2

作为新型冠状病毒感染临床确诊"金标准"的核酸检测试剂,在疫情初期担负重任。相关体外诊断试剂研发的响应速度、生产的规模、临床应用的便捷性和可靠性、检测的准确性和灵敏度等因素,均不同程度的影响疫情防控工作的部署和决策。本文系统地调研了现阶段中、美两国监管机构已批准的138个新型冠状病毒核酸检测试剂,对技术原理、自动化程度以及产品性能等方面进行分析,并对病毒核酸诊断领域未来的发展进行展望。

As the"gold standard"for clinical diagnosis of viral infection of corona virus disease 2019(COVID-19),nucleic acid testing for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)takes the heavy responsibilities in the early stage of the outbreak.The speed of response to the development,the scale of production,the convenience and reliability of clinical application,the accuracy and sensitivity of the nucleic acid testing for SARS-CoV-2 all affect the deployment and decision-making of epidemic prevention and control to varying degrees.This paper systematically investigates 138 new coronavirus nucleic acid testing reagents authorized by regulatory authorities of China and the United States,respectively,at this stage,analyzes the technical principle,degree of automation and analytical performance,and looks forward to the future development of the field of viral nucleic acid testing.