摘要
目的验证两种新型冠状病毒核酸检测试剂盒的主要性能。方法用新型冠状病毒核酸性能验证参考品及广东省室间质控品检测两种新型冠状病毒核酸检测试剂盒的主要性能。结果试剂A、试剂B的检出限分别为1.25E+02、2.5E+02 copies/mL。试剂A在2.0E+03、2.0E+04 copies/mL的精密度参考品N基因检测的批内变异系数(CV)分别为0.37%、0.16%,ORF1ab基因检测的CV分别为0.61%、0.22%;试剂B在2.0E+03、2.0E+04 copies/mL的精密度参考品N基因检测的批内CV分别为1.23%、0.87%,ORF1ab基因检测的CV分别为1.48%、0.54%。两种试剂检测准确度均为100%、无交叉反应、抗干扰实验阳性。结论两种新型冠状病毒核酸检测试剂盒的灵敏度、精密度、准确度、特异性及抗干扰能力均符合产品要求。
Objective To verify the main performance of two novel coronavirus(SARS-CoV-2)nucleic acid detection kits.Methods The main performance of two SARS-CoV-2 nucleic acid detection kits was determined using SARS-CoV-2 nucleic acid performance verification reference and Guangdong provincial quality control products.Results The lowest detection limits of reagent A and B were 1.25E+02 and 2.5E+02 copies/mL,respectively.The intra-assay coefficient of variation(CV)of precision reference N gene detection at 2.0E+03 and 2.0E+04 copies/mL was 0.37%,0.16%in reagent A,and 1.23%,0.87%in reagent B;CV of ORF1ab gene detection was 0.61%,0.22%in reagent A,and 1.48%,0.54%in reagent B.Both reagents showed 100%of accuracy,negative cross reaction,and positive anti-interference.Conclusion The sensitivity,precision,accuracy,specificity,and anti-interference of both kits are coincident with the product requirements.
作者
方炳雄
陈晓佳
刘琪
赵炜
阮杰
FANG Bing-xiong;CHEN Xiao-jia;LIU Qi;ZHAO Wei;RUAN Jie(Precision Medicine Centre,Puning People’s Hospital,Puning 515300,China;College of Medical Technology,Guangdong Medical University,Dongguan 523808,China)
出处
《广东医科大学学报》
2022年第6期630-634,644,共6页
Journal of Guangdong Medical University
基金
广东省医学科学技术研究基金项目(A2020489)
广东省揭阳市科技计划项目(sxm036)。
关键词
新型冠状病毒
核酸检测
性能验证
novel coronavirus
nucleic acid testing
performance verification