YY/T 1516-2017: Translated English of Chinese Standard. YY/T1516-2017: Prolactin Quantitative Labelling Immunoassay Kit
https://www.chinesestandard.net, 2018 M08 17 - 11 pages
This Standard specifies the requirements, test methods, label and use instructions, package, transportation and storage of prolactin quantitative labelling immunoassay kit. This Standard is applicable to the prolactin quantitative determining kit based on the principle of double antibody sandwich method.
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2~3 quality control 30 times test Accuracy actually-measured value Add the prolactin adding Solution appropriate mathematical model average value batch number Between-run precision Blank limit calculate the average coefficient of variation conditions specified correlation coefficient curves are required different concentration document dose-response curve range double logarithm Formula freeze-dried higher than 20.0ÁIU/mL kits labelling immunoassay kit linear interval manufacturer national or international number to repeat package parallel determination parallel t-test potency ratio precision Set 2~3 Prepare the prolactin product not exceeding products with different products with shelf prolactin national prolactin quantitative labelling prolactin with known provisions of 4.2 provisions of GB/T quality control products quantitative labelling immunoassay ratio between actually-measured reagent redissolution relative deviation repeat the test results shall conform select the product Serum Sample Set 2~3 quality standard curve standard deviation standard products system to prepare test methods test results value 𝑥 variation CV Vitro Diagnostic Within-run precision zero-concentration calibration product