YY/T 1249-2014 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of free prostate-specific antigen quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of free prostate-specific antigen (fPSA) based on the double-antibody sandwich method (hereinafter referred to as: fPSA 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 fPSA immunoassay kit. This standard does not apply to: a) reagents for qualitative or semi-quantitative determination of fPSA labeled with colloidal gold or other methods (such as test strips, etc.); b) various types of fPSA radioimmunoassay or immunoradiation labeled with I-class radioactive isotopes Reagent test kit.

YY/T 1249-2014 history

2014 YY/T 1249-2014 Free prostate specific antigen quantitative labelling immunoassay kit