YY/T 1513-2017: Translated English of Chinese Standard. YY/T1513-2017: C-reactive protein testing kit
https://www.chinesestandard.net, 2018 M08 10 - 12 páginas
This Standard specifies the classification, requirements, test method, marking, instructions for use, packaging, transportation and storage for C-reactive protein testing kits. This Standard applies to kits for quantitative determination of C-reactive protein in blood sample (hereinafter referred to as CRP kits) based on the basic principle of antibody-antigen reaction, including the labeling quantitation immune method [such as electrochemiluminescence] and immunoturbidimetry (such as turbidimetric immunoassay and latex particle-enhanced turbidimetric immunoassay). This Standard does not apply to: evaluate the calibration products and quality control products of C-reactive protein; all types of colloidal immunogold labeling test paper.
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30 test results absolute deviation absolute value absorbance If applicable accordance with Formula accuracy analytical sensitivity applicable to turbidimetric batch-to-batch relative range batches of CRP Beijing Biotechnologies blank absorbance change blank limits C-reactive protein testing calculate relative deviation carry out test caused by CRP comply concentration 40 mg/L concentration close conventional C-reactive protein convert in proportion CRP kits CRP of concentration detection limits different concentrations respectively enterprise reference test full-scale C-reactive protein hypersensitivity high-sensitivity Immunoturbidimetry inner-outer package interval of CRP kits and full-scale labeling quantitation immune linear interval linear regression manufacturer shall specify mean value method specified protein testing kits quantitation immune method reagent blank absorbance repeat test twice required in 4.3 requirements of 4.6 results as Xi sample of concentration specified in 5.3 specified in GB/T stability test Take standard deviation Take the CRP test each sample test their reagent Traceability turbidimetric immunoassay Validity stability variable coefficient CV wavelength optical path