一步法及磁珠提取法新型冠状病毒核酸检测试剂在多个检测系统的性能评价

Performance evaluation of 2019-nCoV nucleic acid detection reagents of one-step method and magnetic bead extraction method on different detection systems

目的:采用一步法及磁珠提取法新型冠状病毒(2019-nCoV)核酸检测试剂在3种不同检测系统上进行性能评价。方法:选用临床新型冠状病毒阴性患者口咽拭子样本及企业参考品制备成一定浓度的样本,采用一步法及磁珠提取法在3种品牌的聚合酶链反应(PCR)仪上对新型冠状病毒核酸检测试剂分别进行检出限、阴阳性符合率及精密度的验证。结果:一步法及磁珠提取法在3种品牌的不同检测系统上的检出限均为100%,阴阳性符合率均为100%,精密度验证结果均<5%,在可接受范围内,且性能良好。结论:一步法及磁珠提取法新型冠状病毒核酸检测试剂在3种品牌检测系统上的性能参数符合相关标准,可以用于临床检测工作。

Objective:To evaluate the performances of novel coronavirus(2019-nCoV)nucleic acid detection reagent of one-step method and magnetic bead extraction method on three different detection systems.Methods:Oral throat swab samples of clinical 2019-nCoV negative patients and reference materials of enterprises were selected to product samples with a certain of concentrations.The detection limit,positive and negative coincidence rate and precision of 2019-nCoV nucleic acid detection reagent of one-step method and magnetic bead extraction method were verified on polymerase chain reaction(PCR)instruments of three brands.Results:For the different detection system of three brands,the detection limits both of one-step method and magnetic bead extraction method were 100%,and the negative and positive coincidence rates of them were 100%,and the results of precision verification of them were less than 5%,which were within the acceptable range.And the performances of them were favorable.Conclusion:The performance parameters of 2019-nCoV nucleic acid detection reagent of one-step method and magnetic bead extraction method in the detection systems of three brands can meet relevant standards,and they can be used in clinical detection work.