摘要
目的比较3种全自动核酸提取仪的检测结果,探讨国产全自动核酸提取仪对2019-nCoV RNA的检测性能。方法分别用甲(进口)、乙(国产)、丙(国产)3台全自动核酸提取仪,选用康彻思坦生物2019-nCoV RNA(液体)质控品S5(批号202007002,参考水平1000 cp/mL)作为实验对象,对该质控品进行10~1000倍系列稀释,配制成不同浓度的质控品作为实验样本。其中甲提取仪使用甲配套试剂,乙、丙属于同一厂家不同型号,均使用其配套试剂和第三方试剂,用以评价防污染能力、精密度、准确性、重复性、检测下限及线性相关性。结果以进口品牌甲作为参考标准进行比较;使用乙配套试剂时,乙、丙与甲的线性相关系数分别为:0.980、0.995(N端);0.991、0.983(ORF1ab端);使用第三方试剂时,乙、丙与甲的线性相关系数分别为:0.999、0.915(N端);0.997、0.825(ORF1ab端)。结论国产品牌乙、丙提取仪提取2019-nCoV RNA可以实现全自动操作,相关性较好,系统性能可与国际水平相当,且提取时间较甲短,在标本数量较多时,有明显优势。
Objective To compare the detection results of three kinds of automated nucleic acid purifiers,and to evaluate the detection performance of the domestic 2019-nCoV RNA purifier.Methods Three automated nucleic acid purifiers,namely A(imported),B(domestic),and C(domestic)automated nucleic acid extraction instruments,were used to purify nucleic acid.The Conchestan 2019-nCoV RNA(Liquid)quality control product S5(batch number 202007002,reference level 1000 cp/mL)was chosen as the experimental object.The quality control product was diluted in a series of 10 to 1000 times to prepare experimental samples of different concentrations.Among them,the A nucleic acid purifier used its own matching reagents,and the B and C purifiers belonged to a same manufacturer with different models and used their own supporting reagentsas well as third-party reagents,toevaluate the anti-pollution ability,precision,accuracy,repeatability,detection limit and linear correlation.Results Using the imported brand A as a reference standard for comparison,when using reagents from B,the linear correlation between the two domestic nucleic acid purifiers and the imported equipment were 0.999,0.915(N-terminal),and 0.997,0.825(ORF1ab-terminal),respectively;when using the third-patty reagents,the linear correlation between the two domestic nucleic acid purifiers and the imported equipment were 0.999,0.915(N-terminal)and 0.997,0.825(ORF1ab-terminal),respectively.Conclusion The extraction of 2019-NCOV RNA by domestic nucleic acid purifiers can be fully automated with good correlation.The system performance is comparable to international standards.Moreover,the extraction time of the domestic nucleic acid purifiers is shorter than the imported one,which offers obvious advantages when the number of samples is large.
作者
陈莹
梅勇
魏张静
吴加平
刘恒辰
苏林帆
杨振宇
CHEN Ying;MEI Yong;WEI Zhang-jing;WU Jia-ping;LIU Heng-chen;SU Lin-fan;YANG Zhen-yu(The First People′s Hospital of Jingmen City,Jingmen,Hubei 448001,China;Wuhan University of Science and Technology,Wuhan 430065,China)
出处
《公共卫生与预防医学》
2021年第6期67-70,共4页
Journal of Public Health and Preventive Medicine
关键词
新型冠状病毒
全自动核酸提取仪
性能验证
COVID-19
Automated nucleic acid extractor
Performance verification
