YY/T 1528-2017 Translated English of Chinese Standard. (YYT 1528-2017, YY/T1528-2017, YYT1528-2017): Myoglobin Assay Kit (Immunoturbidimetric Method)This Standard specifies the requirements, test methods, label and operating manual, package, transportation and storage of myoglobin assay kit (immunoturbidimetric method). This Standard is applicable to the assay kit for the quantitative detection of myoglobin in human serum or plasma by the immunoturbidimetric method (transmission method); it includes reagents used on the manual, semi-automatic, fully automatic biochemical analyzers. |
Common terms and phrases
absolute deviation absorbance difference accuracy Analysis sensitivity analysis system Assay Kit Immunoturbidimetric average of test batch biochemical analyzer blank sample calculate the average calculate the relative coefficient of variation Comparing test concentration is 100ng/mL concentration of 100±50 control substance correlation coefficient dilution concentration xi document enterprise reference product Formula GB/T human serum immunoturbidimetric method Inter-batch difference linear range linear regression equation manufacturer meet the requirements Myoglobin Assay myoglobin sample ng/mL of human operating manual period shall meet product not exceeding Reagent blank absorbance record the absorbance reference material reference product test relative deviation relative range repeatability requirements of 3.7a respectively calculate Respectively test results greater sample close sample concentration select the product serum or control specified standard difference system with traceability test concentration test methods test reagent test results yi test The blank test the human Thermal stability test to-be-tested assay valid period Verify the stability Vitro Diagnostic wavelength