一种国产新型冠状病毒核酸快速检测分析仪的性能验证

Performance Verification of A Domestic SARS-CoV-2 Nucleic Acid Rapid Detection Analyzer

目的:评估国产新型冠状病毒核酸快速检测分析仪优思达UC0108的性能,是否满足临床对SARS-CoV-2快速核酸检测要求。方法:依据CNAS-GL039:2019等相关标准和文件,使用国家和广东省临检中心新冠核酸室间质评样品、第三方厂家质控品等,对杭州优思达UC0108新冠核酸快速检测分析仪(含配套试剂盒、耗材)的方法符合率、检出限、交叉反应、抗干扰能力和重复性进行性能验证,验证结果在厂家声明的性能指标范围内或是满足本实验室的执行标准为验证通过。结果:通过检测国家和广东省临检中心室间质评样品5例阴性和15例阳性,方法符合率均100%。通过对邦德盛新冠核酸标准物质稀释至厂家声明的检测限浓度200copies/mL,重复测定5次,100%检出靶核酸。抗干扰能力挑选人类血液(1%)和利巴韦林进行验证,重复测定3次,弱阳性样本仍为弱阳性结果。交叉反应挑选流感嗜血杆菌和肺炎克雷伯菌进行验证,重复检测3次,均为阴性。重复性验证通过2人、20d、2批次试剂盒对昆涞生物阴性和弱阳性质控品进行检测,符合率100%。结论:杭州优思达UC0108新冠核酸快速检测分析仪检测SARS-CoV-2方法符合率、检出限、交叉反应、抗干扰能力、重复性等性能指标达到厂家声明的性能指标,可满足新冠核酸快速检测要求。

Objective:To evaluate the performance of the domestic new coronavirus nucleic acid rapid detection analyzer Ustar UC0108,and whether it meets the clinical requirements for SARS-CoV-2 rapid nucleic acid detection.Methods:According to CNAS-GL039:2019 and other relevant standards and documents,using the national and Guangdong Provincial Pre-Inspection Center new coronal nucleic acid room inter-quality assessment samples,third-party manufacturers quality control products,etc.,the method of Hangzhou Ustar UC0108 new coronary nucleic acid rapid detection analyzer(including kits,consumables)method compliance rate,detection limit,cross-reaction,performance verification of anti-jamming capability and repeatability,the verification results within the scope of the manufacturer’s stated performance indicators or to meet the laboratory’s performance standards for verification pass.Results:Through the testing of the national and Guangdong Provincial Clinical Examination Center,5 cases were negative and 15 cases were positive,and the method compliance rate was 100%.By diluting the Bangdex Covid-19 nucleic acid standard material to the detection limit concentration declared by the manufacturer of 200 copies/mL,repeat the measurement 5 times,and 100%of the target nucleic acid was detected.The anti-interference ability was verified by selecting human blood(1%)and ribavirin.The measurement was repeated 3 times,and the weakly positive samples were still weakly positive.The cross-reaction was verified by selecting Haemophilus influenzae and Klebsiella pneumoniae,and the test was repeated 3 times,all of which were negative.The reproducibility verification was carried out by 2 persons,20 days,and 2 batches of kits to detect Kunlai Bio-negative and weakly positive quality control products,with a compliance rate of 100%.Conclusion:Hangzhou Ustar UC0108 new crown nucleic acid rapid detection analyzer detects SARS-CoV-2 performance indicators such as compliance rate,detection limit,fork reaction,anti-jamming ability and repeatability meet the performance targets declared by the manufacturer,which can meet the requirements of the new coronary nucleic acid rapid detection.