YY/T 1523-2017 Translated English of Chinese Standard. (YYT 1523-2017, YY/T1523-2017, YYT1523-2017): Bicarbonate Assay Kit (PEPC Enzymatic Method)https://www.chinesestandard.net, 2018. 9. 1. - 11페이지 This Standard specifies the requirements, test methods, label and use instructions, package, transportation and storage of bicarbonate assay kit. This Standard is applicable to the reagent kit performing quantitative detection (hereinafter referred to as kit) against the carbon dioxide in the human serum or plasma by phosphoenolpyruvate carboxylase (PEPC) enzymatic method, including the reagent used by manual, semi-automatic, fully automatic biochemistry analyzer. |
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absorbance difference value accuracy added standard solution Analytical sensitivity Test average value batch number Beijing Bicarbonate Assay biochemical analyzer Biochemistry blank sample calculate the mean calculate the relative carbon dioxide certified reference coefficient of variation concentration of 25±5 concentration of detection control substance Difference between batches dilution concentration xi document Enzymatic Method Formula GB/T human sample linear interval linear regression equation Loading amount mean concentration mean value Medical Device meet the requirements method of relative methods specified mmol/L human serum mmol/L interval package PEPC reagent blank absorbance reagent kit record the absorbance Recovery test reference material reference substance relative deviation relative range requirements of 3.3 result of greater separately calculate serum or control Shelf life stability specified in 4.4 standard deviation Take the sample test results test the human Test the reagent Test the sample Thermal stability test Transportation and Storage valid period variation CV Vitro Diagnostic wavelength 𝑥 𝑥i