GB/T 33411-2025Guidelines for enzyme immunoassays kit (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 for standardization documents" Drafting.

This document replaces GB/T 33411-2016 "General Rules for Enzyme-Linked Immunoassay Kits". Compared with GB/T 33411-2016, except for the structure In addition to adjustments and editorial changes, the main technical changes are as follows.

--- Changed the scope of application (see Chapter 1, Chapter 1 of the 2016 edition);

--- Changed the requirements and test methods for detection limits (see 4.4.2 and 5.2, 2.4.1 and 3.3 of the 2016 edition);

--- Deleted the requirements for limit of quantification (see 2.4.2 of the 2016 edition);

--- Added specificity requirements and test methods (see 4.4.3 and 5.3);

--- Added the requirements and test methods for the compliance rate of negative control products (see 4.4.5 and 5.5);

--- Added the requirements and test methods for the compliance rate of positive control substances (see 4.4.6 and 5.6);

--- Changed the requirements and test methods for accuracy (see 4.4.7 and 5.7, 2.6 and 3.5 of the 2016 edition);

--- Changed the precision requirements and test methods (see 4.4.8 and 5.8, 2.5 and 3.4 of the 2016 edition);

--- Added stability requirements and test methods (see 4.4.9 and 5.9);

--- Added sample preparation (see 5.1);

--- Changed the standard curve linearity test method (see 5.4, 3.2 of the 2016 edition);

--- Changed the instruction manual requirements (see Chapter 6, Chapter 4 of the 2016 edition).

1 Scope

This document specifies the general requirements, instruction manual requirements and labels for enzyme-linked immunosorbent assay kits and describes the corresponding test method.

This document applies to the quality evaluation and inspection methods during the research, production and use of enzyme-linked immunosorbent assay kits.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

GB/T 4889-2008 Statistical processing and interpretation of data Estimation and testing of mean and variance of normal distribution

GB/T 44830-2024 General rules for enzyme-linked immunosorbent assay kits

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 General requirements