YY/T 1204-2021Total bile acids assay kit (enzyme cycle method) (English PDF)

Foreword

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

This document replaces YY/T 1204-2013 "Total Bile Acid Determination Kit (Enzyme Cycle Method)", compared with YY/T 1204-2013, the main The technical changes are as follows:

--- Added normative reference document GB/T 29791.2 (see Chapter 2);

--- Changed the measurement principle (see Chapter 4, Chapter 3 of the:2013 edition);

--- Changed the item name of 5.2, and changed "loading amount" to "net content" (see 5.2, 4.2 of the:2013 edition);

--- Changed the requirements and corresponding testing methods (see 5.3~5.8 and 6.3~6.8, 4.3~4.8 and 5.8 of the:2013 edition);

--- Changed the provisions of labels and instructions for use (see Chapter 7, Chapter 6 of the:2013 edition);

--- Changed the regulations on packaging, transportation and storage (see Chapter 8, Chapter 7 of the:2013 edition).

1 Scope

This document specifies the determination principles, requirements, test methods, labels and instructions for use, packaging packaging, transportation and storage.

This document applies to the kit for the quantitative determination of total bile acids in human serum or plasma by the enzyme cycle method (hereinafter referred to as the reagent). kits), including reagents used on manual and semi-automatic, fully automatic biochemical analyzers.

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

3 Terms and Definitions

There are no terms and definitions that need to be defined in this document.

4 Measurement principle

Bile acids are characterized by 3alpha-hydroxysteroid dehydrogenase (3alpha-HSD) and thiooxidized nicotinamide adenine dinucleotide (Thio-NAD)

Heterotropic oxidation produces 3alpha-ketosteroids (3alpha-KS) and thioreduced nicotinamide adenine dinucleotide (Thio-NADH). Generated In the presence of 3alpha-HSD and reduced coenzyme I (NADH), 3alpha-KS produces bile acid and oxidized coenzyme I (NAD). so cycle A large amount of Thio-NADH is produced by the reciprocation. Thio-NADH has an absorption peak near the wavelength of 405 nm, and within a certain reaction time, its light absorption The change of the calibrator is proportional to the total bile acid concentration, and the total bile acid content is calculated according to the change rate of the absorbance of the calibrator.

5 Requirements