Evaluation of the Consistency and Detection Capability of Seven Domestic 2019-nCoV Nucleic Acid Detection Kits / 七种国产新型冠状病毒核酸检测试剂盒的一致性和检出能力评价研究

ABSTRACT

Objective To verify and evaluate the consistency and detection ability of seven 2019-nCoV nucleic acid detection kits, and provide references for clinical application. Methods Two batches of pharyngeal swab samples were collected from 10 2019-nCoV positive patients and 10 clinical highly suspect patients with negative 2019-nCoV test results during January 29 to February 5, 2020 in Shenzhen Luohu People's Hospital. In this work, seven kinds of 2019-nCoV nucleic acid detection kits labeled as Kit A to G, and evaluated for their clinical performance by assessing the consistency with nucleic acid results of clinical samples. A 2019-nCoV positive specimen were selected and diluted to 5-concentration gradient plates (Level-1 to 5) using RNase-free water. These gradient plates were test the kits at each concentration for 5 times to evaluate their detection capacity and the repeatability with-run. Results (1) The negative coincidence rate of 7 kinds of kits were 100%, while the positive coincidence rate were 100% of 6 in kinds of 7 kit, the positive coincidence rate for the other one was 80%. (2) By investigating the repeatability with-run at Level 1 concentration, the CVs of all these 7 kits were below 5%. (3) Between the Level1 and Level3, The detection capability of ORF1ab for Kit a,c,e and g were higher than the remaining, in which the capability of Kit e and g were as high as 93%. The detection capability of N gene for Kit a (100%) was higher than the other kits. Among all 7 kits, the detection capability of ORF1ab and N gene for Kit d were the lowest (ORF1ab40%, N53%), while the capabilities for the other kits were identical. Conclusions The positive and negative coincidence rate of all 7 kinds of nucleic acid detection kits were not obvious differences and had a certain level of detection capability, but some of them still need increasing their detection capability of weak positive samples. Here, in order to confirm the 2019-nCoV nucleic acid detection results of weak positive samples in terms of accuracy, it is suggested to perform the tests by using at least two kits from two individual manufactures.

摘要

目的 比较7种国产新型冠状病毒（2019-nCoV）核酸检测试剂盒的一致性和检出能力，为临床实验室选择检测方法和新型冠状病毒肺炎的诊断提供参考依据。 方法 收集深圳市罗湖区人民医院2020年1月29日至2月5日2019-nCoV感染确诊患者核酸检测阳性和疑似患者核酸检测阴性的咽拭子标本各10例，采用7种试剂盒（编号a~g）分别进行核酸检测，评价7种试剂盒临床标本检测结果的一致性；选取1份阳性标本核酸用无RNA酶水梯度稀释得到5个浓度梯度盘（浓度1~浓度5），比较不同品牌试剂盒的阳性检出率及批内重复性。 结果 6种试剂盒检测20例临床标本的阴性和阳性符合率均为100%，仅1种试剂盒的阳性符合率为8/10，阴性符合率10/10；批内重复性显示7种试剂盒在浓度1水平重复检测病毒载量CV值均<