This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of β-microglobulin quantitative detection reagents (boxes). This standard applies to reagents (kits) for the quantitative detection of β-microglobulin in blood samples or urine samples based on the antigen-antibody reaction as the basic principle [hereinafter referred to as “β-microglobulin reagents (kits)”]. The kit Methodology includes quantitative labeling immunoassays (such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro)chemiluminescence method, etc.) and immunoturbidimetric methods (including immunoturbidimetry, latex-enhanced immunoassay Turbid method). This standard is not applicable to the evaluation of β-microglobulin calibrators and quality control products.
YY/T 1442-2016 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