ISO 15189尿液有形成分分析仪性能验证方案的建立与应用  

Establishment and application of performance verification scheme of urine formed component analyzer according to ISO 15189

作　　者：梁涵瑜 任真 王宏 王琳[1] LIANG Hanyu;REN Zhen;WANG Hong;WANG Lin(Department of Clinical Laboratory,First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China)

机构地区：[1]南京医科大学第一附属医院检验学部

出　　处：《检验医学与临床》2019年第15期2151-2153,2157,共4页Laboratory Medicine and Clinic

摘　　要：目的结合ISO15189及相关行业标准建立一套完整的、用于尿液有形成分分析仪性能验证的方案并进行应用与评价。方法对iQ200全自动尿液显微镜系统的检出限、精密度、识别率、假阴性率、稳定性、携带污染率、生物参考区间、可报告范围进行验证,并评价方案的可行性。结果iQ200全自动尿液显微镜系统的检出限、精密度、识别率、稳定性、生物参考区间、可报告范围的验证结果等均符合评价标准。结论在符合ISO15189相关规定的基础上该方案可用于iQ200全自动尿液显微镜系统的性能验证。Objective To establish a complete set of performance verification scheme used for the urine formed component analyzer by combining with ISO 15189 and related industry standards. Methods The detection limit,precision,recognition rate,stability,biological reference interval,and reportable range in iQ200 automatic urine microscopic system conducted the verification and the scheme feasibility was evaluated. Results The verification results of the detection limits,precision,recognition rate,stability,biological reference interval,and reportable range were all in line with the evaluation criteria. Conclusion Under the basis conforming to the corresponding stipulations of ISO 15189,this scheme can be used for the performance verification of the iQ200 automatic urine microscopic system.

关 键 词：尿液有形成分分析仪 iQ200全自动尿液显微镜系统 性能验证 ISO15189 

分 类 号：R-331[医药卫生]