YY/T 1250-2014 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of insulin quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of human insulin (h-INS) based on the double-antibody sandwich method (hereinafter referred to as: INS kit). It includes using enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling and other labeling methods as capture antibodies, using carriers such as microwell plates, tubes, magnetic particles, microbeads and plastic beads as coating antibodies to quantitatively determine human Insulin immunoassay kit. This standard does not apply to: a) reagents for qualitative or semi-quantitative determination of human insulin labeled with colloidal gold or other methods (such as test strips, etc.); b) various types of human insulin radioimmunoassay labeled with first-class radioactive isotopes. Immunoradiation kit.

YY/T 1250-2014 history