YY/T 1163-2009: Translated English of Chinese Standard. (YYT 1163-2009, YY/T1163-2009, YYT1163-2009): Total Prostate Specific Antigen (t-PSA) Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
https://www.chinesestandard.net, 5. feb. 2015 - 14 sider
This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (chemiluminescent immunoassay).
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according According to different added amount of inspection Amount of sampling Appearance apply assignment batches of reagent Beijing CALCULATE the mean calibrator carriers chemiluminescent immunoassay coefficient of variation component concentration of total conduct corresponding Deviation Bn divided documents Equimolar reactivity factory-exit inspection following contents formula free PSA GB/T inspection items interval labels least the following linear range lower limit manufacturing enterprise Marking materials measurement procedure measurement results minimum detection limit ng/mL Note OBTAIN operation method organization Packaging perform period of validity preparation principle Product name proportion of free prostate specific antigen provisions PSA-ACT complex quantitative detection reagent re-inspection reagent kits reference relative REPEAT requirements requirements of 5.3 respectively results shall comply RLU value selected serum sample solution specific antigen t-PSA standard deviation SD Storage TAKE test methods theoretical concentration Thermal stability total prostate specific total PSA Traceability transportation type inspection variation CV Volume