一种新型冠状病毒核酸检测试剂盒的性能验证

Performance verification of a novel coronavirus nucleic acid test kit

目的验证某公司的一种新型冠状病毒试剂盒的灵敏度、精密度、特异性、抗干扰和准确度五项性能指标,以期评估该试剂盒检测能力是否符合制造商的要求和临床试验的需要。方法选用广州邦德盛生物科技有限公司提供的性能验证参考品和广东省临床检验中心发放的新型冠状病毒室间质评样本作为实验对象,通过荧光PCR法对一种新型冠状病毒检测试剂盒的灵敏度、精密度、特异性、抗干扰和准确度进行性能评估。结果该试剂盒核衣壳蛋白(N)基因和开放阅读框架1ab(ORF1ab)基因最低检测限为250 copies/mL;精密度中浓度和低浓度参考品CV值均小于5%;16种与新型冠状病毒种属相近或引起症状相似的其他病原体以及人类基因组DNA不发生交叉反应;14种干扰物参考品CV值均小于5%;阴性、阳性符合率均为100%(20/20)。结论该新型冠状病毒试剂盒的灵敏度、精密度、特异性、抗干扰和准确度均为合格,说明该试剂盒有良好的性能指标,符合厂家声明,可以应用于临床新型冠状病毒核酸检测。

Objective To verify the sensitivity,precision,specificity,anti-interference and accuracy of a novel coronavirus kit,in order to assess whether the testing capability of the kit meets the requirements of the manufacturer and the needs of clinical trials.Methods To test the sensitivity,precision,specificity,anti-interference,and accuracy of the novel coronavirus detection kit,the performance verification reference provided by Bondson(BDS)Biotechnology Co.,Ltd.,Guangzhou,and the novel coronavirus intraventral quality assessment samples provided by Guangdong clinical laboratory center were chosen as the experimental objects.Results The nucleocapsid protein(N)gene and the open reading framework 1ab(ORF1ab)gene each had a detection limit of 250 copies/mL.All precision reference CV values were under 5%.The remaining 15 diseases related to the novel coronavirus species or causing similar symptoms and human genome DNA did not cross-react.All 14 interferences′CV values were under 5%.Positive and negative findings coincided 100%of the time(20/20).Conclusion The sensitivity,precision,specificity,anti-interference and accuracy of a novel coronavirus kit are qualified,indicating that the kit has good performance indicators,conforms to the manufacturer′s declaration,and can be used in clinical nucleic acid detection of novel coronavirus.