罗氏Cobas c501检测系统尿素分析测量范围的验证及评价

Evaluation and Validation of Analytical Measurement Range of Urea Detected by Roche Cobas c501 Full-Automatic Biochemistry Assay System

目的:核实并评价罗氏Cobasc501检测系统尿素分析测量范围。方法:主要参照美国临床实验室标准化委员会(NCCLS)指南文件EP6-P的要求,收集含高值待测物的新鲜病人血清,按一定比例混合、离心,计算混合物的浓度并将之作为高值样品(H),与经同样处理获得的低值样品(L)分别按5L、4L+1H、3L+2H、2L+3H、1L+4H、5H的关系配制,形成系列样品,在罗氏Cobasc501检测系统上对各样品的尿素进行检测,每个样品检测4次,数据进行回归分析。结果:回归方程为y=0.9889x+0.19,b=0.9889,介于0.97～1.03之间,ta小于t0.05,说明截距与0无显著性差异,回归直线事实上通过零点。结论:罗氏Cobasc501检测系统检测尿素的分析测量范围为0.7～49.9mmol/L,宽于厂家提供的分析测量范围0.5～40.0mmol/L,完全符合临床检验要求。

Objective： To evaluate and validate analytical measurement range of urea detected by Roche Cobas c501 full-automatic biochemistry assay system. Methods： Referring to NCCLS EP6-P evaluation protocols mainly. First, fresh sera from patient were collected and mixed to formed the high（H） and low（L） urea concentration sample respectively. Second, serial sera were produced according to the relation of 5L, 4L＋1H, 3L＋2H, 2L＋3H, 1L＋ 4H, 5H. Last, Urea of each sample were detected four times by Roche Cobas c501 full-automatic biochemistry assay system, and data were obtained and analyzed. Results： Regression equation of y=0.9889x＋0.19 is deduced, and the b value（0.9889） is between 0.97～1.03. compared a to 0, tat0.05, which shows standard curve is through zero in fact. Conclusion： Analytical measurement range of urea detected by Roche Cobas c501 full-automatic biochemistry assay system is actually 0.7～49.9 mmol / L and wider than analytical measurement range 0.5～40.0 mmol / L afforded by manufactory.