新一代快速核酸检测分析仪的性能验证
Performance Verification Analysis of a New Generationof Rapid Nucleic Acid Detection Analyzer
艾晓娟 1孙菲 1李名慧 1彭飞武 1周皓1
作者信息
- 1. 湖南国际旅行卫生保健中心(长沙海关口岸门诊部) 长沙 410007
- 折叠
摘要
本研究验证评估新型冠状病毒(SARS-CoV-2)全流程一体化即时检测(Point-of-Care Testing,POCT)设备的性能,重点分析其是否满足口岸现场SARS-CoV-2的快速检测要求.本文采用100例海关口岸口咽拭子样本和第三方质控品,全面评估全流程一体化POCT核酸检测设备的符合率、精密度、检出限等技术参数.结果显示,符合率试验中阴性和阳性样本检出符合率均为100%;精密度试验重复性CV值分别为1.47%和1.68%,均小于5%;灵敏度检出限为100 copies/mL;检出时限为25 min,适用预期用途,满足海关口岸现场的快速检测需求.
Abstract
This study validated and evaluated the performance of the full-process integrated Point-of-Care Testing(POCT)device for the novel coronavirus(SARS-CoV-2),focusing on whether it meets the requirements of rapid on-site detection of SARS-CoV-2 at customs ports.100 samples of throat swabs at customs ports and third-party quality controls were used to comprehensively evaluate the conformity rate,precision,detection limit and other technical parameters of the full-process integrated POCT nucleic acid detection device.The results showed that the coincidence rates of positive and negative samples were both 100%.The reproducibility CV values of precision test were 1.47%and 1.68%,respectively,both of which were less than 5%.The detection limit of sensitivity was 100 copies/mL.The detection time was 25 minutes.The test results show that the conformity rate,sensitivity,precision and other performance indicators of the SARS-CoV-2 detection method of the equipment can be applied to the intended use and meet the needs of rapid detection at customs ports.
关键词
新型冠状病毒/POCT/快速检测/性能验证Key words
novel coronavirus(SARS-CoV-2)/Point-of-Care Testing(POCT)/rapid detection/performance verification引用本文复制引用
基金项目
海关总署科研项目(2022HK094)
湖南省自然科学基金青年基金(2023JJ40269)
出版年
2024
NETL
NSTL
万方数据