罗氏电化学发光免疫分析仪检测系统的性能验证  

Performance Verification of Roche Electrochemiluminescence Immunoassay Detection System

作　　者：韩清臣 HAN Qing-chen(Department of Clinical Laboratory,Tianjin Binhai New Area Hospital of Traditional Chinese Medicine,Tianjin 300450)

机构地区：[1]天津市滨海新区中医医院检验科

出　　处：《中国医疗器械信息》2020年第3期15-16,共2页China Medical Device Information

摘　　要：目的:为了对罗氏电化学发光免疫分析仪检测系统的性能进行验证。方法:按照国家临床实验室标准委员会制定的各项标准对罗氏电化学发光免疫分析仪检测系统的精密度、正确度、线性范围、灵敏度以及最低检测限等进行检验。结果:罗氏电化学发光免疫分析仪的精密度、正确度、线性范围、灵敏度以及最低检测限等各项检测内容均符合相关标准要求。结论:罗氏电化学发光免疫分析仪检测系统性能经检验显示合格,能够有效满足临床诊疗工作需求。Objective:To verify the performance of the detection system of Roche electrochemical luminescence immunoassay analyzer.Methods:The precision,accuracy,linearity,sensitivity,and minimum detection limit of the Roche electrochemical luminescence immunoassay detection system were tested according to the standards formulated by the National Clinical Laboratory Standards Committee.Results:The accuracy,accuracy,linear range,sensitivity,and minimum detection limit of Roche electrochemical luminescence immunoassay analyzer met the requirements of relevant standards.Conclusion:The performance of the Roche electrochemical luminescence immunoassay detection system has been verified to be qualified,and it can effectively meet the needs of clinical diagnosis and treatment.

关 键 词：罗氏电化学发光免疫分析仪 检测系统 性能检验 

分 类 号：TH776[机械工程—仪器科学与技术]