YY/T 1179-2010 in English

本标准规定了糖类抗原CA50定量测定试剂(盒)(化学发光免疫分析法)的分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于以化学发光免疫分析法为原理定量测定人糖类抗原CA50 试剂(盒)。包括以微孔板、管、磁颗粒、微珠和塑料珠等为载体的酶促及非酶促化学发光免疫分析测定试剂(盒)。
本标准不适用于:
a) 拟用于单独销售的肿瘤标志物校准品和肿瘤标志物质控品;
b) 以化学发光免疫分析为原理的生物芯片。

Scope

This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of carbohydrate antigen CA50 quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human carbohydrate antigen CA50 reagent (kit) [hereinafter referred to as "CA50 reagent (kit)"] based on the principle of chemiluminescence immunoassay. Including enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. This standard does not apply to: a) Tumor marker calibrators and tumor marker substance control substances intended to be sold separately; b) Biochips based on chemiluminescence immunoassay.