YY/T 1161-2009: Translated English of Chinese Standard. (YYT 1161-2009, YY/T1161-2009, YYT1161-2009): Tumor Associated Antigen CA125 Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, identification, labels, instructions, packaging, transportation and storage of tumor associated antigen CA125 quantitative determination reagent (kit) (chemiluminescence immunoassay). This standard is applicable to quantitative detection of tumor associated antigen (CA125) reagent (kit), based on the principles of chemiluminescence immunoassay. It includes the enzymatic and non-enzymatic chemiluminescence immunoassay detection reagent (kit) with carriers of micro-plates, tubes, magnetic particles, micro-beads and plastic beads. This standard is not applicable to the requirements of calibrators and quality control products in the kit.
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According to different antigen CA125 quantitative applied CA125 calibrators associated antigen CA125 batch of reagent Beijing CA125 Quantitative Detection Calculate the mean chemical reaction chemiluminescence immunoassay reagent Coefficient of variation component of reagent detect the accuracy device registration certificate ex-factory inspection following contents GB/T inspection items inspection quantity Instructions of reagent instrument-automatic operation item is unqualified least the following linear range M+2SD measurement procedure Medical device registration methods of 6.3 micro-beads and plastic Minimum detectable concentration minimum detection limit non-enzymatic chemiluminescence immunoassay Number of medical Packaging perform the detection period of validity photon procedure of traceability Product name qualified quantitative detection reagent quantity The sampling reagent kits reference value registration certificate number reinspection requirements of 5.3 requirements of 5.6 results shall comply retained-sample quantity Sampling quantity SD of 10-times serum sample standard deviation SD terms and definitions tumor associated antigen type inspection U/mL allowable variation variation CV vitro diagnostic Within-batch difference