YY/T 1164-2021Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic assay) (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1. Structure and Drafting Principles of Standardization Documents" drafted.

This document replaces YY/T 1164-2009 "Human Chorionic Gonadotropin (HCG) Test Strip (Colloidal Gold Immunochromatography)", and Compared with YY/T 1164-2009, in addition to editorial changes, the main technical changes are as follows:

--- Added normative references GB/T 29791.1-2013, GB/T 29791.2; deleted the diagnosis of human chorionic gonadotropin Procedures for the manufacture and inspection of reagents (colloidal gold method) (2000) (see Chapter 2, Chapter 2 of the:2009 edition);

---Added qualitative detection, semi-quantitative detection, detection limit, C5~C95 interval in terms and definitions; deleted human chorionic gonadotropin Terms and definitions of test strips (see Chapter 3, Chapter 3 of the:2009 edition);

--- Modified the width requirements and corresponding detection methods (see 4.1.2 and 5.2.2, 4.1.2 and 5.3.2 of the:2009 edition);

--- Modified the requirements for the speed of movement and the corresponding detection methods (see 4.1.3 and 5.2.3, 4.1.3 and 5.3.3 of the:2009 edition);

--- Modified the detection limit requirements and corresponding detection methods (see 4.1.4 and 5.2.4, 4.2 and 5.4 of the:2009 edition);

--- Modified negative specificity and positive specificity, unified as specificity (see 4.1.5, 4.3 of the:2009 edition);

--- Added semi-quantitative requirements and corresponding detection methods (see 4.2 and 5.3);

--- Modified the provisions of labels and instructions for use (see Chapter 7 of the:2009 edition);

--- Increased packaging should comply with the provisions of GB/T 191 (see 7.1).

1 Scope

This document specifies the human chorionic gonadotropin (HCG) detection kit (colloidal gold immunoassay)

Immunochromatography) (hereinafter referred to as HCG test strip) terms and definitions, technical requirements, test methods, labels and instructions for use, packaging, transportation, storage.

This document is applicable to the qualitative and semi-quantitative detection of HCG content in human urine samples based on the principle of colloidal gold immunochromatography. Reagent test kit.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 Graphical signs of packaging, storage and transportation

GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1. Terms, definitions and common enquiries

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use

3 Terms and Definitions

The terms and definitions defined in GB/T 29791.1-2013 and the following apply to this document.