YY/T 1213-2013: Translated English of Chinese Standard. (YYT 1213-2013, YY/T1213-2013, YYT1213-2013): Follicle stimulating hormone quantitative labelling immunoassay kit
https://www.chinesestandard.net, 2014年12月8日 - 11 頁
This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the follicle stimulating hormone quantitative labelling immunoassay kit. This standard is applicable to follicle stimulating hormone (FSH) kit that is quantitatively determined and based on the principle of double antibody sandwich method. It includes the FSH immunoassay kit of quantitative determination by using enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence labelling and other labelling methods as the capture antibodies; and taking micro-plates, tubes, magnetic particles, micro-beads and plastic beads and others as the carrier coated antibodies. This standard does not apply to: a) Colloidal gold labeled FSH test strip; b) Various types of FSH radio-immunity or IRMA kit labeled with 125I and other radioactive isotopes.
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accordance with provisions Analytical internal precision Analytical within-precision antibodies Appearance and physical appropriate mathematical model areas of dose-response batches of products calibrator chemiluminescent labelling coefficient of variation control measured results corresponding concentration Device Registration Certificate different areas dose-response curves double logarithmic enzyme labelling follicle stimulating hormone following contents FSH kits FSH national standard hormone quantitative labelling IU/L labelling FSH labelling methods Linearity lower than 200 lowest detection limit manual operation mean value measured value Medical Device Registration micro-beads and plastic Minimum detection limit model to perform national standard material Number of medical Packaging Period of validity physical examination plastic beads potency ratio Product batch number Product name products are set provisions of 4.1 provisions of Clause quality control products quantitative labelling immunoassay reacting dose Registration Certificate Number results of quality Specificity stability stimulating hormone quantitative Storage conditions taking micro-plates three quality control value of quality variation CV Within-batch precision