This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of carcinoembryonic antigen (CEA) quantitative determination reagents (kits). This standard applies to quantitative determination reagents (kits) for the quantitative determination of human carcinoembryonic antigen (CEA) based on the principle of chemiluminescence immunoassay, including enzymatic reagents using microwell plates, tubes, magnetic particles, microbeads and plastic beads as carriers. and non-enzymatic chemiluminescence immunoassay assay reagents (boxes). This standard does not apply to the requirements for calibrators and quality control materials in kits.
YY/T 1160-2009 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