YY/T 1223-2014 in English

本标准适用于以竞争法为原理定量测定总甲状腺素（TT4）的试剂盒，包括以酶标记、（电）化学发光标记、（时间分辨）荧光标记等标记方法，微孔板、管、磁颗粒、微珠和塑料珠等作为载体的定量测定TT4的免疫分析试剂盒。
本标准规定了总甲状腺素定量标记免疫分析试剂盒的定义、组成、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等内容。

Scope

This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of total thyroxine quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of total thyroxine (TT) based on the principle of competition method (hereinafter referred to as: TT kit). It includes immunoassay kits for quantitative determination of TT using labeling methods such as enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling, etc., and microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. This standard does not apply to: a) colloidal gold-labeled TT test strips; b) various types of TT radioimmunoassay or immunoradiation kits labeled with Class I radioactive isotopes.