罗氏MODULAR P800全自动生化分析仪检测系统性能验证

目的按《医疗机构临床实验室管理办法》和《医学实验室质量和能力认可准则》ISO15189的要求对新的检测系统罗氏MODULAR P800全自动生化分析仪的分析性能进行验证。方法按美国临床实验室标准化协会CLSI的指南文件EP5-A2、EP15-A2、EP6-A2、C28-A2的要求,对罗氏MODULAR P800全自动生化分析仪进行精密度、准确度、线性范围、参考区间4个性能进行验证,并与厂商声明的性能或公认的质量标准进行比较。结果批内精密度、批间精密度均小于1/4Tea(CLIA′88);对卫生部5份室间质控品检测结果与靶值进行比对做相关性分析,相关系数r2在0.99以上,精密度、准确度、可报告范围、生物参考区间与厂商提供的性能指标相符。结论罗氏Modular生化分析仪的主要分析性能符合质量目标要求。

Verification of analytical performance of Roche Modular P800 Automatic Biochemistry Analyzer

Objective To verify the analytical performance of Roche Modular P800 Automatic Biochemistry Analyzer according to ISO15189 requirement of Medical Institution Clinical Laboratory Management Measures and Medical Laboratory Quality and Competence Accreditation Criteria.Methods The precision,accuracy,linearity and reference interval were validated according to Clinical and Laboratory Standards Institute（CLSI） documents（EP5-A2,EP15-A2,EP6-A2 and C28-A2）,the results were compared with manufacturer′ s claims and acceptable quality standards.Results The within and between-batch precisions were all less than 1/ 4 Tea（CLIA′88）.A strong correlation existed between the detection values and target values of five external quality assessment control samples from Ministry of Public Health,with r^2 above 0.99.The precision,accuracy,clinical reportable range and biotic reference interval were in line with manufacturer′s standards.Conclusion The main analytic characteristics of Modular P800 Automatic Biochemistry Analyzer are consistent with acceptable quality standards.