Standard No.:	YY/T 1214-2013
English Name:	Human chorionic gonadotrophin quantitative labelling immunoassay kit
Chinese Name:	人绒毛膜促性腺激素定量标记免疫分析试剂盒
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	SDA
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	superseded
Superseded by:	YY/T 1214-2019 Human chorionic gonadotrophin detection kit
Superseded on:	2020-8-1
Target Language:	English
File Format:	PDF
Word Count:	5000 words
Translation Price(USD):	140.0
Delivery:	via email in 1~3 business day

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