强生Vitros350生化仪测定血清尿素和肌酐的性能验证

Demonstration of vitros 350 assay system estimating Urea and Creatinine in serum

目的对强生Vitros350生化仪测定血清尿素和肌酐进行性能验证，探讨其临床应用价值。方法参照美国强生公司提供的验证方案，对测定项目尿素和肌酐的精密度、准确度、线性范围和临床参考区间进行验证，并与奥林巴斯AU2700生化仪进行相关性比较。结果尿素和肌酐的准确度、精密度、可报告范围、临床参考区间均符合厂商说明；观察到有部分标本的肌酐检测结果与AU2700生化仪测定结果有一定的差异，可通过稀释的方法解决。结论强生Vitros350生化仪测定血清尿素和肌酐的基本性能符合公司声明要求。

Objective To demonstrate the function of Vitros 350 assay system estimating urea and creatinine in seum, and study its value in clinical application. Methods According to the demonstration project provided by Johnson＆Johnson corporation, we demonstrated the accuracy, reliability, linear range and clinical reference range of urea and creatinine, The results were compared with Olympus AU 2700 assay system. Results The accuracy, reliability, linear range and clinical reference range of urea and creatinine accorded with the declaration of the corporation, The results of creatinine in some samples were different between the two systems, which can be solved by dilution. Conclusions The function of vitros 350 is accorded with the declaration of the corporation.