YY/T 1458-2016 in English
VALIDAntibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
- Issued on:2016-01-26
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
本标准规定了抗甲状腺过氧化物酶抗体定量检测试剂(盒)(化学发光免疫分析法)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抗甲状腺过氧化物酶抗体试剂(盒)。
Scope
This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of anti-thyroid peroxidase antibody quantitative detection reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human anti-thyroid peroxidase antibody reagent (kit) based on the principle of chemiluminescence immunoassay [hereinafter referred to as "Anti-TPO reagent (kit)"]. Anti-TPO reagents (boxes) can be divided into enzymatic and non-enzymatic chemiluminescent immunoassay reagents (boxes) according to different chemiluminescence principles. According to different operating procedures, they can be divided into manual operation methods and automatic instrument operation methods.

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