This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of anti-thyroid peroxidase antibody quantitative detection reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human anti-thyroid peroxidase antibody reagent (kit) based on the principle of chemiluminescence immunoassay [hereinafter referred to as "Anti-TPO reagent (kit)"]. Anti-TPO reagents (boxes) can be divided into enzymatic and non-enzymatic chemiluminescent immunoassay reagents (boxes) according to different chemiluminescence principles. According to different operating procedures, they can be divided into manual operation methods and automatic instrument operation methods.
YY/T 1458-2016 Referenced Document
GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1458-2016 history
2016YY/T 1458-2016 Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)