【摘要】 目的 评估全自动核酸提取纯化及实时荧光PCR分析系统检测新型冠状病毒核酸的性能。方法 根据新型冠状病毒感染防控方案，研究购自上海生工的全自动核酸提取纯化及实时荧光PCR分析系统、2019-nCoV试剂盒、不同浓度的新型冠状病毒核酸检测标准品，对样品的阴阳性符合率、精密性、变异系数、最低检出限、重复性、检测时长等指标进行检测，并根据检测结果验证、评估自动核酸提取纯化及实时荧光PCR分析系统性能。结果 样本的阴、阳性符合率均为100.00%,精密性阳性符合率均为100.00%,变异系数(coefficient of variation,CV)为≤5.00%,最低检出限循环阈值(cycle threshold, Ct)<43.00,阳性检出率为100.00%,重复性阴、阳性符合率均为100.00%,设备检测时长2h以内。结论 根据本研究结果，该系统特异性强、重复性好，同时最低检出限和精密性均符合现场使用要求，可有效降低操作风险，且检测时长较传统PCR短，可大规模适用于口岸一线。更多还原

【Abstract】 Objective To evaluate the performance of a fully automated nucleic acid extraction and purification and real-time fluorescence PCR analysis system for detecting SARS-CoV-2 nucleic acid.Methods According to the SARS-CoV-2 infection prevention and control scheme, research on the fully automated nucleic acid extraction and purification and real-time fluorescence PCR analysis system purchased from Sangon Biotech(Shanghai),2019-nCoV kit, and different concentrations of SARS-CoV-2 nucleic acid detection standard substance.The positive and negative compliance rate, precision, coefficient of variation, lowest detection limit, repeatability and detection duration of the samples were tested, and the performance of automated nucleic acid extraction and purification and real-time fluorescence PCR analysis system was validated and evaluated according to the test results.Results The positive and negative agreement rates of the samples were 100.00%,the precision positive agreement rates were 100.00%,the coefficient of variation(CV) was ≤5.00%,and the cycle threshold(Ct) of the lowest detection limit was <43.00.The positive detection rate was 100.00%,the repeatable negative and positive agreement rates were 100.00%,and the detection duration of equipment was within 2h.Conclusion According to the results of this study, the system demonstrates high specificity and good repeatability, the lowest detection limit and precision meet the on-site use requirements, which can effectively reduce the operational risk, and the detection time is shorter than the traditional PCR,it can be applied to the front line of the ports on a large scale.更多还原