新型冠状病毒检测系统性能验证分析

Performance Verification and Aualysis of SARS-CoV-2 Detection System

目的验证新型冠状病毒核酸检测系统,分析是否满足口岸新型冠状病毒(SARS-CoV-2)快速检测要求。方法依据《医学实验室质量和能力认可准则在分子诊断领域的应用说明》(CNAS-CL02-A009)要求,评估新型冠状病毒核酸检测系统(包括核酸提取试剂、核酸提取仪、PCR扩增试剂和PCR仪)检测性能,主要包括防污染情况、符合性、检出限、重复性和抗干扰能力等技术参数。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,该检测系统的灵敏度可以达到约102copies/ml,重复性CV值均在4%以内;抗干扰能力选择在咽拭子标本采集管中加入5%的全血、5%的氯化钠、布地奈德鼻喷雾剂(5%),结果符合率100%。结论本次验证SARS-CoV-2的检测系统防污染措施、符合性、检出限、重复性和抗干扰能力等性能指标与试剂厂家声明一致,本检测系统可满足SARS-CoV-2实验室快速检测需求。

Objective To verify the SARS-CoV-2 nucleic acid detection system and analyze whether it meets the requirements for rapid detection of the new coronavirus(SARS-CoV-2)at the port.Methods According to the requirements of“Application of Medical Laboratory Quality and Capability Accreditation Guidelines in the Field of Molecular Diagnosis”(CNAS-CL02-A009),the new coronavirus nucleic acid detection system(including nucleic acid extraction reagents,nucleic acid extraction instruments,PCR amplification reagents and PCR instrument)detection performance,mainly including technical parameters such as anti-pollution,compliance,detection limit,repeatability and anti-interference ability.Results In the environmental test and the cross-contamination test of high-concentration samples,the negative coincidence rate and the positive coincidence rate were both 100%;the sensitivity test results showed that the sensitivity of the detection system can reach about102copies/ml,and the repeatability CV value is 4.The anti-interference ability was selected by adding 5%whole blood,5%sodium chloride,and budesonide nasal spray(5%)to the throat swab specimen collection tube,and the result coincided with 100%.Conclusion The performance indicators such as anti-pollution measures,compliance,detection limit,repeatability,and anti-interference ability of the detection system for SARS-CoV-2 are consistent with the reagent manufacturer’s statement.This detection system can meet the requirements of SARS-CoV-2 laboratories.Rapid detection needs。