罗氏Modular全自动生化分析系统脂类项目性能验证实验分析

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

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%～10.67%之间,低于卫生部允许的偏差范围;各项目可报告范围试验测定值结果与预测值接近,重复试验各项目结果相关性好(r>0.975),线性理想(斜率接近1);生物参考区间与厂商提供的性能指标相符。结论:罗氏Modular全自动生化分析仪检测项目TC、TG、HDL-C、LDL-C在精密度、准确度、线性范围及生物参考区间四个方面均达到了临床生化检验的实验要求。

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.