滨州高碘区健康人群FT3、FT4、TSH、TPOAb的参考区间探讨

Binzhou high iodine area healthy population FT3,FT4,TSH,TPOAb reference interval discussion

目的：以我院查体中心检测过的健康人群的FT3、FT4、TSH和TPOAb的检验结果为例，探讨建立滨州高碘地区相关检测项目的参考区间。方法：按照CLSI文件C28-P3《医学实验室参考区间的定义、建立和确认》中的推荐方法，参考ISO15189：2003（E）《医学实验室—质量和能力的专用要求》条款要求，先引用权威书刊、厂家试剂说明书或转移其他医院实验室的生物参考区间，然后进行实验验证，验证不通过的项目，收集480例健康参考个体自建适用于本实验室的生物参考区间，定期进行临床评审。结果：FT3、FT4、TSH现用生物参考区间验证通过，可以继续使用：TPOAb验证不通过，不适用，须自建生物参考区间，自建区间为0-36IU／ml。结论：采用本研究方法确立本地区健康人群FT3、FT4、TSH和TPOAb的参考区间，从多途径保证检验指标的生物参考区间可靠、准确、科学、实用。能确保相关参考区间符合临床要求，值得推广应用。

Objective ： In our hospital physical examination center detected in the healthy population of FT3, FT4, TSH and TPOAb test results for example, explore the establishment of Binzhou high iodine area correlation detection project reference interval. Methods ： In accordance with the CLSI file C28-P3 ＂ medical laboratory reference intervals are defined, to establish and confirm the ＂ recommendation method in reference ISO15189：, 2003 （ E ） ＂ medical laboratories - Particular requirements for quality and competence ＂ clause requires, first cited authority books, manuals or transfer reagents other hospital laboratory reference intervals, and then verified by experiments, validation of the project, from 480 healthy individuals since reference applicable to the laboratory reference intervals, regular clinical review.Results ： FT3, FT4, TSH now uses the biology reference interval of the authentication is passed, can continue to use; TPOAb verification is not passed, not applicable, to establish the biology reference interval, since the interval 0-36IU/ml. Conclusions ： By adopting the research methods to establish the healthy population in FT3, FT4, TSH and TPOAb reference intervals, from multiple pathways to guarantee the test indexes of the biology reference interval of reliable, accurate, scientific, practical, can ensure that relevant reference intervals in accordance with the clinical requirements, it is worthy of popularization and application.