YY/T 1582-2018 Translated English of Chinese Standard. (YYT 1582-2018, YY/T1582-2018, YYT1582-2018): Colloidal gold immunochromatography readerhttps://www.chinesestandard.net, 2021. 1. 10. - 19페이지 This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of colloidal gold immunochromatography analyzers. This standard is applicable to instruments that interpret the results of samples by measuring the reflectivity of the bands in the reaction zone of the colloidal gold reagent card. This standard does not apply to instruments that use fluorescent labels or other labeling methods for rapid immunoassay. |
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according to formula area frame arithmetic mean block for metering calculate the correlation calculate the relative certified reference materials coefficient of variation Comparison test control and laboratory control strip Test correlation coefficient electrical equipment Electromagnetic compatibility Environmental test equipment for measurement Figure A.1 filling setting following methods image processing software immunoassay Instruction manual linear regression matching reagent test measurement area measurement gray block Measurement grey-scale block measuring the reflectivity medical decision level medium and low meet the requirements method of quality method specified Metrology minimum value Perform test according Production date quality control strip reagent test sample reflectivity measurement reflectivity range reflectivity value relative deviation repeat the measurement requirements for electrical requirements of GB/T result of sample results shall meet RGB setting value Safety requirements shown in Figure standard reflectivity whiteboard Table A.1 test methods Test quality control Test the quality value B value value of quality variation CV