YY/T 1578-2018 Translated English of Chinese Standard. (YYT 1578-2018, YY/T1578-2018, YYT1578-2018): Glycated albumin assay kit (enzymatic method)https://www.chinesestandard.net, 2 août 2020 - 11 pages This standard specifies the requirements, test methods, labeling and instruction manuals, packaging, transportation and storage requirements for glycated albumin assay kits. This standard applies to the use of enzymatic kits for quantitative detection of glycated albumin in human serum or plasma, including reagents used on manual and semi-automatic, fully automatic biochemical analyzers. |
Expressions et termes fréquents
absolute deviation absorbance change According to formula accuracy shall meet albumin concentration analytical sensitivity assay kits average value Beijing biochemical analyzer blank absorbance blank sample calculate the relative certified reference coefficient of variation Comparison test concentration of glycated control substance correlation coefficient detection reagent’s blank Differences between batches dilution concentration xi document g/L of glycated GB/T glycated albumin assay human serum kit to test linear interval linear regression equation manufacturer measured value Medical Device meet the requirements methods of 4.4 packaging reading point specified Reagent blank’s Reagent blank’s absorbance reagent’s blank absorbance Record the absorbance reference substance relative deviation relative range Repeat the test requirements of 3.3 requirements of 3.7a respectively calculate sample concentration samples close select products serum or control Standard deviation test result test the human tests meet Thermal stability test traceability analysis system transportation and storage Validity period stability variation CV verify the stability vitro diagnostic wavelength