摘要：参考新版《体外诊断试剂注册管理办法》及YY/T 1222-2014《总三碘甲状腺原氨酸定量标记免疫分析试剂盒》等一系列新法规的要求，对二类诊断试剂总三碘甲状腺原氨酸的审评关注点技术要求、临床评价、检测报告、说明书进行总结分析。

    关键词：总三碘甲状腺原氨酸；注册审评；定量

    Registration Review Concerns of the Total Three Iodine -Thyroid Acid Assay Kit under the New Regulations

    LI Feng-mei

    (Guangdong Food and Drug Administration，Review and Certification Center，Guangzhou 510080，Guangdong，China)

    Abstract：Refer to the new provisions on IVD registration and YY/T 1222-2014 Totle T3 quantitative labelling immunoassay kit ......