一种国产新型冠状病毒核酸检测试剂盒的性能验证

目的　评估一种国产新型冠状病毒（SARS-CoV-2）核酸检测试剂盒是否满足临床SARS-CoV-2 核酸检测要求。方法　采用15 例SARS-CoV-2 核酸阳性和15 例SARS-CoV-2 核酸阴性的临床样本，1 支SARS-CoV-2 RNA 干粉标准品，5 支阳性定值参考品和5 支阴性定值参考品，对该试剂盒检测SARS-CoV-2 阴性和阳性符合率、精密度、检出限和交叉反应进行验证。结果　20 例阴性和20 例阳性样本的N 基因和ORF1ab 基因阴阳符合率均为100%。2 例阳性样本ORF1ab 基因重复性CV 为0.41%~0.56%，优于N 基因重复性，N 基因和ORF1ab 基因重复性、实验室总不精密度CV均＜ 5%。检出限重复20 次的检出率为100%，SARS-CoV-2 与常见呼吸道病原体、与SARS-CoV-2 同种属病毒（人副流感病毒1 型、鼻病毒、MERS，SARS，甲型流感病毒、乙型流感病毒、冠状病毒HKU1,NL63,229E 和OC43）之间不产生交叉反应。 结论　该试剂盒阴阳性符合率一致，重复性好。SARS-CoV-2 与常见呼吸道病原体，与SARS-CoV-2 同种属病毒不会产生交叉反应，适用于临床实验室和检测机构进行SARS-CoV-2 核酸筛查。

Performance Evaluation of A Domestic New Coronavirus Detection Kit

Objective　To evaluate whether a domestic novel coronavirus (SARS-CoV-2) nucleic acid detection kit meets therequirements of clinical new coronavirus nucleic acid detection. Methods　Fifteen positive and negative clinical samples, oneSARS-CoV-2 RNA dry powder standard, and five positive and negative reference samples were collected to verify the negativeand positive coincidence rate, precision, detection limit, and cross-reactivity for SARS-CoV-2. Results　The negative andpositive coincidence rate of both N gene and ORF1ab gene were 100% (20 negative and positive samples). CV of ORF1ab generepeatability was 0.41%~0.56% and better than that of N gene. The CV of repeatability and total laboratory imprecision of bothN gene and ORF1ab gene were all less than 5%. The detection rate was 100% with 20 repeats. Common respiratory pathogensand viruses of the same genus as the new coronavirus (human parainfluenza virus type 1, rhinovirus, MERS, SARS, influenzaa virus, influenza b virus, coronavirus HKU1, NL63, 229E, OC43) were no cross-reaction with the SARS-CoV-2. Conclusion　The kit had the same negative and positive coincidence rate, and good reproducibility. SARS-CoV-2 did not have cross-reactionwith common respiratory pathogens and viruses of the same species as the SARS-CoV-2. It is suitable for clinical laboratory andtesting institutions for SARS-CoV-2 nucleic acid screening.