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1 Translated English of Chinese Standard: Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 44 Prolactin Quantitative Labelling Immunoassay Kit 泌乳素定量标记免疫分析试剂 ( 盒 ) Issued on: March 28, 2017 Implemented on: April 01, 2018 Issued by: China Food and Drug Administration Buy True-PDF Auto-delivery. Page 1 of 11

2 Table of Contents Foreword Scope Normative References Classification Requirements Test Methods Label and Use Instructions Package, Transportation and Storage... 9 Bibliography Buy True-PDF Auto-delivery. Page 2 of 11

3 Prolactin Quantitative Labelling Immunoassay Kit 1 Scope 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. This Standard is not applicable to the prolactin semi-quantitative determining reagent (such as test paper strip, etc.) labelled by colloidal gold or other methods; neither the various prolactin radioimmunoassay or immunoradiometric kits labelled by radioisotopes such as 125 I. 2 Normative References The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. GB/T Packaging Pictorial Marking for Handling of Goods GB/T In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer (Labelling) - Part 2: In Vitro Diagnostic Reagents for Professional Use 3 Classification According to the different labelling methods, it can be divided into enzyme labelling, (electro) chemiluminescence labelling, (time-resolved) fluorescent labelling; according to different solid-phase carriers, it can be divided into microporous plate type, tube type, magnetic particles, microspheres, and plastic beads, etc.; according to different operation process, it can be divided into manual operation method and instrument automatic operation method. Buy True-PDF Auto-delivery. Page 4 of 11

4 curve of the kit; the coefficient of variation (CV) of the test results of manual test kit shall be no higher than 10.0%; the coefficient of variation (CV) of the test results of the automatic test kit shall be no higher than 8.0% Between-run precision Set 2~3 quality control products with different concentration in the dose-response curve range of kit, and between 3 different batches of products; the coefficient of variation (CV) of the test results shall be no higher than 15.0%. 4.6 Specificity Test the human growth hormone (GH) sample with concentration of 200ng/mL; its test results shall be no higher than 20.0µIU/mL. 4.7 Stability End-of-shelf-life stability Store the kit under the specific condition until the end of shelf life; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and Thermal stability Place the kit for a certain period of time at 37 C; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and Stability after redissolution of the freeze-dried reagent Re-dissolve the freeze-dried components in the kit as per the specified conditions; place for a certain period of time under the conditions specified by the manufacturer; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and NOTE 1: Generally, products with shelf life of 1 year shall select the products not exceeding 1 month; products with shelf life of half a year shall select the product not exceeding half a month; and so on. However, if the specified time is exceeded, the products are acceptable when they meet the requirements. NOTE 2: Thermal stability cannot be used to derive the shelf life of products; unless using the derivation formula based on a large number of stability studies. NOTE 3: According to the product characteristics, one of the above methods of or can be selected for verification; however, the selected method shall verify the product stability; so that ensure the product performance in the shelf life meets the standard requirements NOTE 4: If the kit contains the freeze-dried standard products and the like components; and they shall be placed for certain period of time after redissolution; then it shall carryout the Buy True-PDF Auto-delivery. Page 6 of 11

5 CV- coefficient of variation; s standard deviation of 10 times test results; x average value of 10 times test results Between-run precision Use the kits with three different batch number to repeat the test for 10 times against the quality control products with different concentration; calculate the average value (x ) of the test results and standard deviation (s); calculate the coefficient of variation (CV) as per Formula (4); the results shall conform to the provisions of CV- coefficient of variation; s standard deviation of 30 times test results; x average value of 30 times test results. 5.6 Specialty Use the kit buffer system to prepare the specialty sample into the prescribed concentration; parallel determined for twice; its measurement results shall conform to the provision of Stability After the kit is stored according to the conditions specified in 4.7, test as per the method stipulated in 5.2, 5.3, 5.4, 5.5.1; the results shall conform to the provisions of Label and Use Instructions It shall conform to the provisions of GB/T Package, Transportation and Storage 7.1 Package Buy True-PDF Auto-delivery. Page 9 of 11