YY/T 1214-2013 in English

本标准规定了人绒毛膜促性腺激素定量标记免疫分析试剂盒的分类、要求、试验方法、标识、标签和使用说明书、包装、运输和贮存。
本标准适用于以双抗体夹心法为原理定量测定人绒毛膜促性腺激素(HCG)的试剂盒(以下简称:HCG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为捕获抗体,以微孔板、管、磁颗粒、微珠和塑料珠等为载体包被抗体,定量测定HCG的免疫分析试剂盒。
本标准不适用于:
a) 胶体金标记HCG试纸条;
b) 用125I等放射性同位素标记的各类HCG 放射免疫或免疫放射试剂盒

Scope

This standard specifies the classification, requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of human chorionic gonadotropin quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of human chorionic gonadotropin (HCG) based on the double-antibody sandwich method (hereinafter referred to as: HCG kit). It includes using enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling and other labeling methods as capture antibodies, using microwell plates, tubes, magnetic particles, microbeads and plastic beads as carriers to coat the antibodies, and quantitatively determine HCG immunoassay kit. This standard does not apply to: a) colloidal gold-labeled HCG test strips; b) various types of HCG radioimmunoassay or immunoradiation kits labeled with radioactive isotopes such as 125I.