摘要：目的 以总蛋白（TP）为例，考察Roche Cobas C501全自动生化分析仪的精密度、准确度和可报告范围，以验证其检测性能。方法 参考美国临床和实验室标准化协会（CLSI）EP5-A2、EP6-A等文件，使用C501的原装配套试剂及校准品，检测总蛋白（TP）的精密度、准确度和可报告范围，用EP Evaluator 软件统计分析。结果 TP两水平精密度检测结果的批内标准差（SD）、总的SD均不超过验证值，精密度可以接受；在对照系统与实验系统之间，20个患者血清样本的检测结果的误差指数（EI）均在±1.00之间，准确度可以接受；覆盖可报告范围的5个水平样本中的4个结果呈线性，线性可接受。结论 Cobas C501分析仪TP项目的精密度、准确度、可报告范围达到了厂家声明的检测性能，此分析仪的检测性能得到了验证。

Abstract：Objective To verify the precision, accuracy and linearity of Cobas C501 automatic biochemical analyzer by using total protein (TP) as a reference. Methods According to EP5-A2, EP6-A etc from Clinical and Laboratory Standards Institute (CLSI), TP was analyzed with Roche original reagent and calibrator to verify Cobas C501 automatic biochemical analyzer precision, accuracy and linearity. The EP evaluator software was applied for statistics analysis. Results In the 2 levels of TP, both of within standard deviation (SD) and total SD were less than verification value. The precision was acceptable. 20 specimens were measured by control instrument and experiment instrument; all of error indexes (EI) were in ±1.00 range. The accuracy verification passed. In linearity evaluation, the results of four of the five specimens over the reportable range were linear which indicating linearity was acceptable. Conclusion The precision, accuracy and linearity of TP detected by Cobas C501 system reach the performance that the manufacturer claimed．