新型冠状病毒全自动一体化快速检测设备性能验证分析

Performance Verification of Fully Automatic Integrated Rapid Detection Equipment for SARS-CoV-2

目的评估新型冠状病毒全自动一体化快速检测设备的性能,分析是否满足口岸新型冠状病毒(SARS-CoV-2)快速检测要求。方法使用上海计量科学研究院新型冠状病毒标准品和100例口岸鼻咽拭子样本,评估全自动一体化快速检测设备(包括配套试剂和耗材)防污染情况、符合性、检出限、重复性、检测时限等技术参数。结果在环境测试以及高浓度样本交叉污染的测试中,阴性符合率和阳性符合率均为100%;灵敏度试验结果显示,该设备的灵敏度可以达到约10~2copies/mL,重复性CV值均在4%以内。结论本次验证设备检测SARS-CoV-2的方法防污染措施、符合性、检出限、重复性等性能指标与厂家声明一致,可满足SARS-CoV-2实验室检测需求,更便于实验室检测向一线口岸现场前移,尤其是陆路口岸。

Objective To evaluate the performance of a fully automatic integrated rapid detection equipment for novel coronavirus,and to analyze whether it meets the requirements for rapid detection of novel coronavirus(SARS-CoV-2)at ports.Methods Using Shanghai Institute of Metrology’s new coronavirus standard and 100port nasopharyngeal swab samples to evaluate the pollution prevention,compliance,detection limit and repeatability of the automatic integrated rapid detection equipment(including supporting reagents and consumables),detection time limit and other technical parameters.Results In the environmental test and the cross-contamination test of high-concentration samples,the negative coincidence rate and the positive coincidence rate were both100%;the sensitivity test results showed that the sensitivity of the device can reach about 10~2copies/mL,and the repeatability CV value is 4%.within.Conclusion The anti-pollution measures,compliance,detection limit,repeatability and other performance indicators of the method for the detection of SARS-CoV-2 in this verification equipment are consistent with the manufacturer’s statement,which can meet the needs of laboratory detection of SARS-CoV-2,thus making the experiment more convenient The laboratory testing is moving forward to the firstline ports,especially the land ports.