室间质量评价计划用于体外诊断仪器的性能评价

介绍了室间质量评价的目标、国家标准,以及我国开展临床检验室间质量评价的惰况。通过对2001年全国临床化学室间质量评价结果的分析,可以看到临床化学分析仪在用户实验室中的使用性能。由此可见,可以通过室间质量评价来对临床检验分析仪器的性能进行监测和评价。

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic devices

This article is described the goals, standard, philosophy and elements of external quality assurance in clinical laboratories. Through the analysis of the results in the China National External Quality Assessment in clinical chemistry analytes, we can find the performance of the different clinical chemistry analyzers in the participating laboratory. We can use of EQA schemes in the assessment of the performance of in-vitro diagnostics devices.