YY/T Translated English of Chinese Standard: YY/T

Transcription

1 Translated English of Chinese Standard: YY/T YY ICS C 44 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA YY/T Thyroid-stimulating hormone quantitative labelling immunoassay kit 促甲状腺素定量标记免疫分析试剂盒 Issued on: October 21, 2013 Implemented on: October 1, 2014 Issued by: State Food and Drug Administration Page 1 of 11

2 Table of Contents Foreword Scope Normative references Classifications Requirements Test methods Identifications, labels and instructions Packaging, transportation and storage Bibliography Page 2 of 11

3 Foreword This Standard is drafted according to the rules specified in GB/T Please note that some contents in this Standard may involve patents. The issuing authority of this Standard does not undertake the responsibility to identify these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC 136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China. Drafting organization of this Standard: National Institutes for Food and Drug Control. The main drafters of this Standard: Huang Ying, Li Lili, Yu Ting, and Gao Shangxian. Page 3 of 11

4 Thyroid-stimulating hormone quantitative labelling immunoassay kit 1 Scope This Standard specifies the classification, requirements, test methods, marks, labels, instructions, packaging, transportation, and storage of the thyroid-stimulating hormone quantitative labelling immunoassay kit. This Standard is applicable to the quantitative determination of thyroid-stimulating hormone (TSH) kit (hereinafter referred to as TSH kit ) based on the principle of double antibody sandwich method. It includes the immunoassay kit for quantitative determination of TSH by using labelling methods such as enzyme labelling, (electrical) chemiluminescent labelling, and (time resolution) fluorescence labelling AS capture antibody; and taking microplates, pipes, magnetic particles, microbeads and plastic beads etc. AS the carrier coated antibody. This Standard does not apply to: a) Colloidal gold labelled TSH test strip; b) Various types of radio-immunity or IRMA kit labelled with 125 I and other radioactive isotopes. 2 Normative references The articles contained in the following documents have become part of this Document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document. YY/T Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements 3 Classifications According to different labelling methods, TSH kit can be divided into the enzyme-labelled TSH kit, (electrical) chemiluminescent labelled TSH kit, (time resolution) fluorescence labelled TSH kit and the like. According to the solid carrier, it can be divided into TSH kits with carriers of microplates, pipes, magnetic particles, microbeads, and plastic beads etc. Page 4 of 11

5 Two or three quality control products are set up in different areas of dose-response curves. The coefficient of variation (CV) of measured value of quality control products shall comply with the provision of 4.5.2, among not-less-than 3-times independent analysis. The calculation method is the same as Note: Among Independent analysis include: Among different independent experiments, among different time periods within the validity of the kit, among different experiments with the same operator, and among different operators, etc Precision between-batches Two or three quality control products are set up in different areas of dose-response curves. The coefficient of variation (CV) of measured value of quality control products shall comply with the provision of 4.5.2, among at least 3 batches of products for independent analysis. The calculation method is the same as Measured value of quality control products Two or three quality control products are set up in different areas of dose-response curves. The measured results of the kit shall comply with the provision of Specificity The sample with specificity shall be prepared to a prescribed concentration by using the kit buffer system. The measured results of the kit shall comply with the provisions of 4.7.1, and Stability After the kit is preserved according to the provisions of or 4.8.2, the inspection results shall comply with the provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, and Identifications, labels and instructions 6.1 The identifications and labels of the kit s external packaging boxes shall comply with the provision of YY/T , and at least contain the following contents: a) Product name and specification; b) Name, address and contact information of manufacturers; c) Medical device registration certificate number and product standard number; d) Product batch number; e) Period of validity; Page 8 of 11

6 Bibliography [1] GB/T Statistical terms - Part 1: General statistical terms and terms used in probability [2] JJF General Terms in Metrology and Their Definitions [3] Ye Yingwu. National Guide to Clinical Laboratory Procedures Third Edition Nanjing: Southeast University Press, 2006 [4] YY/T Medical Devices - application of risk management to medical devices [5] State Pharmacopoeia Commission. General principles of the radiation immunoassay kit, 2005 [6] State Pharmacopoeia Commission. Requirements for China Biological Products (2000 Edition) [7] Guo Zuchao. Medical mathematical statistical method; Third Edition; Beijing: People s Medical Publishing House, 1988 END Page 11 of 11