YY/T 1216-2013
Alpha-fetoprotein quantitative labelling immunoassay kit (English Version)
- Standard No.
- YY/T 1216-2013
- Language
- Chinese, Available in English version
- Release Date
- 2013
- Published By
- Professional Standard - Medicine
- Status
- 2021-06
- Replace By
- YY/T 1216-2020
- Latest
- YY/T 1216-2020
- Scope
- This standard specifies the classification, requirements, test methods, instructions for use, identification, labeling, packaging, transportation, and storage of alpha-fetoprotein quantitative labeling immunoassay kits. This standard applies to labeled immunoassay kits for quantitative determination of alpha-fetoprotein (hereinafter referred to as AFP kits). Including using enzyme labeling, 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 immunoassay reagents for quantitative determination of AFP box. This standard does not apply to: a) colloidal gold-labeled AFP test strips; b) various types of radioimmunoassay or immunoradiation kits labeled with radioactive isotopes such as 125I.
YY/T 1216-2013 history
- 2020 YY/T 1216-2020 Alpha-fetoprotein assay kit
- 2013 YY/T 1216-2013 Alpha-fetoprotein quantitative labelling immunoassay kit
