YY/T 1233-2014 Translated English of Chinese Standard. (YYT 1233-2014, YY/T1233-2014, YYT1233-2014): Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)

This Standard specifies the terms and definitions, requirements, test methods, marking, labeling, instructions, packaging, transportation, and storage of cardiac troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent immunoassay). This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI) quantitative detection reagent (kit) by the principal of chemiluminescent immunoassay, including the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers such as microplates, tubes, and magnetic particles. This Standard does not apply to the requirements for the calibrator and control materials in reagent (kit).