GB/T 44830-2024General rules for determination of enzyme-linked immunosorbent assay kit (English PDF)

1 Scope

GB/T 44830-2024 sets the general rules for testing with enzyme-linked immunosorbent assay kits. ELISA kits are the workhorse of food, feed and environmental screening in China - for mycotoxins, veterinary drug residues, allergens and pathogens - because they are cheap, quick and usable outside a specialist laboratory; that same accessibility is why results vary so much between users, since the kit insert is the only protocol and it differs from maker to maker. The standard describes the assay process and sets the general requirements for performing it and for the result report, with informative annexes on the criteria for evaluating precision within the working range and on evaluating agreement with a reference method. It took effect on 26 October 2024.

This document describes the assay process of an enzyme-linked immunosorbent assay kit and specifies the general requirements for assay by the enzyme-linked immunosorbent assay kit and result report. This document applies to assay by the enzyme-linked immunosorbent assay kit.

2 Normative References

The contents of the following documents constitute indispensable clauses of this document through the normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.

GB/T 4889-2008 Statistical Interpretation of Data - Techniques of Estimation and Tests Relating to Means and Variances of Normal Distribution

GB 19489 Laboratories - General Requirements for Biosafety

3 Terms and Definitions

The following terms and definitions are applicable to this document.

3.1 negative sample A sample in which the target analyte is not detected by standard laboratory analytical methods or classical methods.

3.2 positive sample A sample in which the target analyte is detected by standard laboratory analytical methods or classical methods.

4 General Requirements

4.1 Enzyme-Linked Immunosorbent Assay Kit The enzyme-linked immunosorbent assay kit shall be in complete packaging; labels and markings shall be clear and standardized; an instruction manual or equivalent guidance document shall be attached, and the document shall include at least the following contents.

b) Scope of application. including the target analyte and applicable matrix range of assay;

c) Assay principle;

d) Kit composition, storage conditions and expiration date;

e) Equipment and reagents required for tests;

f) Operating instructions. including solution preparation, sample preparation, detailed assay procedures and result calculation;

g) Precautions. including key operating points, safety tips, analysis and solutions to common problems.

4.2 Laboratory Laboratory biosafety management shall comply with the relevant requirements in GB 19489.

4.3 Assay Indicators Standard curve, limit of detection, precision, accuracy and cross-reactivity.