5种新型冠状病毒核酸检测试剂盒的一致性和检出能力  

Consistency and Detection Ability of Five Novel Coronavirus Nucleic Acid Test Kits

作　　者：朱秀霞 潘晓芳[1] 黄燕虹[1] 汤智[1] 吴静标[1] Zhu Xiuxia;Pan Xiaofang;Huang Yanhong;Tang Zhi;Wu Jingbiao(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《医疗装备》2025年第5期39-42,共4页Medical Equipment

基　　金：广东省药品监督管理局(2024ZDZ16)。

摘　　要：目的评价不同国产新型冠状病毒核酸检测试剂盒在疾病筛查、诊断中的应用效果。方法选取2021年3月至2022年4月于医院或核酸检测点接受核酸检测的56例疑似新型冠状病毒肺炎患者的咽拭子样本,采用不同国产新型冠状病毒核酸检测试剂盒(编号分别为A、B、C、D、E)进行核酸检测,比较不同试剂盒检查结果一致性、目标基因(N基因和ORF1ab基因)批内重复性和试剂盒检出能力。结果56例疑似新型冠状病毒肺炎患者经临床诊断确诊阳性29例,试剂盒A、B、C、D、E的阳性、阴性符合率均为100%,检查结果一致性较好。在浓度1条件下的N基因检测,试剂盒C的批内重复性最好,而试剂盒E的批内CV最大。在浓度1条件下的ORF1ab基因检测,试剂盒A的批内重复性最好,而试剂盒C的批内CV最大。在浓度2条件下的N基因检测,试剂盒C的批内重复性最好,而试剂盒B的批内CV最大。在浓度2条件下的ORF1ab基因检测,试剂盒A的批内重复性最好,而试剂盒E的批内CV最大。在浓度3条件下的N基因检测,试剂盒E的批内重复性最好,而试剂盒A的批内CV最大。在浓度3条件下的ORF1ab基因检测,试剂盒B的批内重复性最好,而试剂盒D的批内CV最大。浓度1、2条件下,5种试剂盒的N基因和ORF1ab基因阳性检出率一致,在浓度3的条件下,试剂盒E的N基因阳性检出率最高,试剂盒B最低;试剂盒D的ORF1ab基因阳性检出率最高,试剂盒B最低。结论5种新型冠状病毒核酸检测试剂盒的检出能力存在差异性,试剂盒D、E的检测能力相对更好。Objective To explore the application effect of different domestic novel coronavirus nucleic acid detection kits in disease screening and diagnosis,and to evaluate the consistency and detection ability.Methods Pharyngeal swab samples from 56 patients with suspected novel coronavirus pneumonia who underwent nucleic acid testing between March 2021 and April 2022 were selected for nucleic acid testing using different domestic novel coronavirus nucleic acid test kits(the numbers are A,B,C,D,and E)to compare the consistency of the results of the different kits,the within-batch reproducibility of the target genes(N and ORF1ab genes),and the detection of the kits ability.Results Twenty-nine out of 56 patients with suspected novel coronavirus pneumonia were diagnosed,and the positive and negative compliance rates for kits A,B,C,D,and E were 100%,with good consistency of results.For the N gene assay under concentration 1 conditions,C had the best intra-batch reproducibility,while E had the largest intra-batch CV.In the ORF1ab gene assay under concentration 1 conditions,A had the best intra-batch reproducibility,while C had the largest intra-batch CV.For the N gene assay under concentration 2 conditions,C had the best intra-batch reproducibility while B had the largest intra-batch CV.For the ORF1ab gene assay under concentration 2 conditions,A had the best intra-batch repeatability while E had the largest intra-batch CV.For the N gene assay under concentration 3 conditions,E had the best intra-batch reproducibility while A had the largest intra-batch CV.For the ORF1ab gene assay at concentration 3 conditions,B had the best intra-batch reproducibility while D had the largest intra-batch CV.The positive detection rates of N and ORF1ab genes of the five kits were consistent under the conditions of concentration 1 and 2.Under the condition of concentration 3,kit E had the highest positive detection rate of N gene and kit B had the lowest;kit D had the highest positive detection rate of ORF1ab gene and kit B had the lowest.Concl

关 键 词：新型冠状病毒 核酸检测试剂盒 一致性 检出能力 

分 类 号：R446.5[医药卫生—诊断学]