2015年医疗器械检测机构促甲状腺素定量检测能力比对实验分析报告

Inter-laboratory comparison analysis report for determination of thyroid-stimulating hormone of medical device testing institutions in 2015

目的了解我国医疗器械检验机构检测能力,以促进检测水平的整体提高。方法中国食品药品检定研究院在2015年组织全国医疗器械检验机构促甲状腺素定量检测能力比对实验,统一向各参加检测机构提供比对试验样本和促甲状腺素酶联免疫吸附测定试剂盒,通过比较检测结果是否落在(指定值±3SD)范围内进行结果判定。结果 16家(94.1%)检测结果满意,1家检测机构2个样本检测结果未在范围内。结论大部分检测机构比对实验数据准确、可靠,个别检测机构在质量体系管理中存在漏洞,影响了检验质量。

Objective To understand the detection capabilities of medical device testing institutions in China, and to promote the overall improvement of detection level. Methods National Institutes for Food and Drug Control had carried out inter-laboratory comparison by detecting thyroid-stimulating hormone in the national medical device testing institu- tions in 2015. Comparison samples and thyroid-stimulating hormone enzyme-linked immunosorbent assay （ELISA） kits were provided centrally to participate in the test. All results were judged by whether the resuhs were in the range of （specify values _＋3SD）. Results The results showed that 16 laboratories were satisfied, and the passing rate was 94.1%. The results of two samples from one medical device testing institutions were not in the scope. Conclusion Data from most of medical device testing institutions are accurate and reliable. The vulnerability exists in the quality management in a few institutions, which affects the detection quality.