罗氏Modular全自动生化分析系统脂类项目性能验证实验分析

目的:评价罗氏Modular全自动生化分析系统项目总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)的分析性能.方法:按照临床实验室标准化协会(CLSI)指南文件EP5、EP15、EP6和其他相关文献的实验方案,对罗氏Modular全自动生化分析仪检测TC、TG、HDL-C、LDL-C的精密度、准确度、线性范围及生物参考区间进行了验证,并与厂商声明的性能或公认的质量标准进行比较.结果:批内精密度均小于1/4Tea(CLIA' 88),批间精密度均小于1/3Tea(CLIA'88);准确度实验结果为各项目的平均偏倚(SE％)在1.596％～10

Performance Verification Test analysis of Lipids Items Measurement by Roche Modular Automatic Biochemical System

Objective:To validate the analytic characteristic of Total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C) and low density lipoprotein cholesterol(LDL-C) measurement by Roche Modular automatic biochemical analyzer.Methods:The precision,accuracy,linear range and biotic reference interval of TC、TG、HDL-C and LDL-C were validated according to Clinical and(CLSI) documents(EP5,EP15,EP6) and other experimental procedures.The results were compared with manufacturer’s claims and acceptable quality standards.Results:The within precisions were all less than 1/4 Tea(LCIA’88),The between precisions were all less than 1/3Tea(LCIA’88).The average bias of each testing items was 1.596%～10.67% in the accuracy evaluation experiments,which is under the NCCLS permitted bias;The reportable ranges of each testing items were close to the expected values;Estimate of repeatability each testing items showed good correlation(r>0.975) and linearity.Biological reference intervals were in line with manufacturer’s standards.Conclusion:The main performance of precision,accuracy,the linear range and biological reference interval of Roche Modular full-automatic biochemical analyzer system were consistent with the performance claims of clinical biochemical examination.