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)https://www.chinesestandard.net, 2015 M02 15 - 11 pages 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). |
Common terms and phrases
according to formula according to GB/T acute myocardial infarction Analytical specificity average value batches of reagent Between-batch difference blank limit CALCULATE according CALCULATE the average cardiac troponin cardiac troponin-I cTnI certified reference materials chemiluminescent immunoassay coefficient of variation component of reagent critical value cross reactants Cross reaction rate detect a same-sample DETECT the accuracy detection reagent kit Document enterprise shall provide expired-sample Explanation of analytical following contents Instructions of reagent interval of normal items shall meet least the following Limit of blank linear interval measurement results Medical Device meet the requirements perform detection Product lot number Product name quantitative detection reagent Recovery test relative deviation requirements of 4.3a results shall meet RLU value sample to perform serum sample Shanghai skeletal troponin solution-A Stability in validity standard deviation SD terms and definitions Test methods Thermal stability test Traceability Manufacturing enterprise traceable assignment process validity period value of acute zero-concentration calibrator