YY/T 1162-2009: Translated English of Chinese Standard. (YYT 1162-2009, YY/T1162-2009, YYT1162-2009): Alpha-fetoprotein quantitative detection reagent (kit) (Chemiluminescent immunoassay)
https://www.chinesestandard.net, 8 de dez. de 2014 - 13 páginas
This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, identification, labels, instructions, packaging, transportation and storage of alpha-fetoprotein quantitative detection reagent (kit) (chemiluminescence immunoassay). This standard is applicable to the quantitative detection of the alpha-fetoprotein quantitative detection reagent (kit) in the human blood matrix or other body fluid components, based on the principle of chemiluminescence immunoassay. It includes the enzymatic and non-enzymatic chemiluminescence immunoassay detection reagent (kit) in 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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100 IU/mL allowable According to different AFP quantitative Alpha-fetoprotein AFP alpha-fetoprotein quantitative detection batch of reagent Beijing blood matrix Calculate the mean chemical reaction chemiluminescence immunoassay reagent Coefficient of variation component of reagent detect the accuracy device registration certificate documents so quoted ex-factory inspection following contents formula GB/T inspection items inspection quantity Instructions of reagent instrument-automatic operation item is unqualified IU/mL allowable variation least the following linear range mean value 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 Product name qualified quantitative detection reagent quantity The sampling reagent kits registration certificate number reinspection requirements of 5.3 requirements of 5.8 result shall comply retained-sample quantity Sampling quantity serum sample Shanghai standard deviation SD terms and definitions Traceability The manufacturer type inspection variation CV vitro diagnostic Within-batch difference zero-concentration calibrator