摘要
目的评价自主研发的针对2019新型冠状病毒的多重核酸检测试剂的性能指标及临床验证。方法通过测试本试剂盒的准确性、灵敏度、特异性、精密度等指标,评估研发试剂盒的性能指标;同时,在临床单位收集60例临床样本,统计本试剂盒对临床样本中2019新型冠状病毒的检出结果,并与诊疗指南推荐的确诊/排除方法的结果进行比较,评估试剂在临床检验中的适用性。结果新研制的试剂盒各性能指标均符合要求:阳性符合率和阴性符合率均为100%,对各阳性参考品和阴性参考品能够准确检出;灵敏度测试经过确认和验证过程确定本试剂盒的最低检测限浓度为350copies/ml;特异性测试显示对具有潜在交叉可能的病原体和具有潜在干扰作用的药物进行测试,检出结果均正常,未受到交叉病原体和干扰物质的影响,特异性良好;精密度测试结果符合要求,批内精密度和批间精密度均<5%;对60例临床样本进行检测,与参比方法相比,灵敏度为95%(19/20),特异性为100%(41/40),经分析和参比方法检出结果差异不显著(P> 0.05)。结论建立的2019新型冠状病毒核酸检测试剂盒达到国内临床诊断试剂所要求的主要性能指标,可以满足临床样本的检测,是一种快速、准确的检测方法,可应用于临床。
Objective To evaluate the performance and clinical validation of novel coronavirus 2019 multiple nucleic acid detection reagent. Methods The negative compliance rate, positive compliance rate, LOD, specificity, precision and other indicators were tested, and the performance indicators of the kit was evaluated. At the same time, 60 cases of pharyngeal swab samples were collected in hospital, and the detection results of novel coronavirus 2019 were compared with the results of the diagnosis/exclusion method recommended by the diagnostic guidelines, so as to evaluate the applicability of the reagent in clinical detection. Results All the performance indicators of the newly developed kit meet the requirements: the positive compliance rate and the negative compliance rate were 100%, which indicates the positive reference and the negative reference can be accurately detected. LOD of the kit was 350 copies/ml. The specificity test showed that the pathogen and the drug were tested, and the test results were normal. The precision test results meet the requirements. The precision within batches and between batches is < 5%. Compared with the control method, the sensitivity was 95%(19/20) and the specificity was 100%(41/40). There was no significant difference in the detection results between the analysis and the control method(P > 0.05). Conclusions The novel coronavirus 2019(SARS-CoV-2) nucleic acid detection kit reaches the main performance indexes required by domestic clinical diagnostic reagents, which can be applied to clinical test.
作者
孟影
陈春峰
张小燕
沈维祥
郜恒骏
MENG Ying;CHEN Chun-feng;ZHANG Xiao-yan;SHEN Wei-xiang;GAO Heng-jun(National Engineering Center for Biochip,Shanghai 201203,China)
出处
《中国医药生物技术》
2020年第3期230-234,共5页
Chinese Medicinal Biotechnology
