Comparative analysis of detection performance of novel coronavirus nucleic acid detection reagents.

Abstract

Objective To evaluate the detection performance of novel coronavirus nucleic acid reagents (Maccura Biological Co.,Ltd,fluorescent PCR method),it is validated clinically and used the same kinds of kits for comparsion research.Methods Compared with novel coronavirus nucleic acid reagents (Shanghai Zhijiang Biological Co.,Ltd,fluorescent PCR method),the similar products of Maccura Biological Co.,Ltd was to be estimated.Pharyngeal swab specimens of 14 COVID-19 patients diagnosed by the CDC and 211 general admission patients from February 18 to 24 were taken into our study,and two kits were used for parallel testing novel coronavirus (ORF1ab/N/E gene).Results The positive rate and negative coincidence rate of Maccura detection kit and Zhijiang' were more than 99.5%.Relative deviation of ORF1ab gene and N gene were not more than ±16%.Conclusion Novel coronavirus nucleic acid detection reagents produced by Maccura Biological Co.,Ltd has good consistency with similar reagents approved for marketing,which can meet the needs of clinical testing. (English) [ABSTRACT FROM AUTHOR] 目的 对迈克生物股份有限公司的新型冠状病毒核酸试剂盒(荧光PCR法)进行临床验证,并 用同类试剂盒进行比对研究。方法 以迈克生物股份有限公司的研发生产的新型冠状病毒核酸检测试剂盒 (荧光PCR法)作为待考核试剂,以上海之江生物科技有限公司的同类产品作为比对试剂。分别对14例由疾控 中心确诊的新型冠状病毒肺炎患者和2020年2月18日至2月24日211例普通入院患者的咽拭子标本进行新 型冠状病毒(ORF1ab/N/E基因)检测,比较两种试剂检测检出率的一致性。结果 迈克新型冠状病毒核酸检 测试剂盒与之江新型冠状病毒核酸检测试剂盒的检测结果阳性率和阴性符合率均达99.5%以上,ORF1ab基 因和N 基因测定值相对偏差不超过±16%。结论 迈克新型冠状病毒核酸检测试剂盒与已获批准上市的同类 试剂检测结果一致性良好,可满足临床检测需求。 (Chinese) [ABSTRACT FROM AUTHOR] Copyright of Journal of Modern Medicine & Health is the property of Journal of Modern Medicine & Health and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)