YY/T 1218-2013Thyroid-stimulating hormone quantitative labelling immunoassay kit (English PDF)

Foreword

This Standard is drafted according to the rules specified in GB/T 1.1-2009.

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 125I 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 0466.1-2009 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.

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 5.5.1.

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.

5 Test methods

6 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 0466.1, 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;

Bibliography [1] GB/T 3358.1 Statistical terms - Part 1. General statistical terms and terms used in probability [2] JJF 1001-2011 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 0316-2008 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 […]