一种新型冠状病毒核酸检测试剂在4个检测体系中的检出限分析

Determination limits of a severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent in 4 determination systems

目的验证一种新型冠状病毒核酸检测试剂在4个不同检测体系中的检出限,以提升新型冠状病毒核酸检测质量。方法选择1个试剂配套体系和3个非配套体系,使用中国计量科学研究院新型冠状病毒全序列假病毒核糖核酸标准物质验证检出限性能,并对未通过验证的体系进行分析,以查找原因。结果该试剂在4个检测体系中检出限验证均通过,其中非配套体系1检出能力最强,其次为配套体系和非配套体系2。缩短细胞裂解、核酸释放与磁珠结合时间、减少核酸洗涤次数会影响试剂检出限。结论该试剂检出限性能可满足检测需求。相关部门应出台相应仪器的生产标准和校准标准;实验室应关注加样量、非配套体系的优化和仪器设备的维护、保养、校准。

Objective To verify and analyze the determination limits of a severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent in 4 determination systems,and to improve the quality of severe acute respiratory syndrome coronavirus 2 nucleic acid determination.Methods One matched determination system and 3 unmatched determination systems were selected,and the determination limit performance was verified by the severe acute respiratory syndrome coronavirus 2 nucleic acid reference material of the National Institute of Metrology,China.The reasons of failed verification systems were analyzed.Results The determination ability of unmatched system 1 was strong,followed by matched system 1 and unmatched system 2.Shortening the time of cell lysis,nucleic acid release and magnetic bead binding and reducing the number of nucleic acid washing affected the determination limit.Conclusions The severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent selected in this study could pass the determination limit verification.It is urgent for relevant departments to issue production standards and calibration standards for corresponding instruments.Laboratories should pay attention to sample addition amount,the optimization of unmatched systems and the maintenance and calibration of instruments.