GB/T 40265-2021General rules for determination of enzyme immunoassay antibodies (English PDF)
酶免疫检测抗体检测通则
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
May 21, 2021
Implementation date
December 1, 2021
Scope
GB/T 40265-2021 is the English-translated version of 酶免疫检测抗体检测通则.
GB/T 40265-2021 sets general rules for testing antibodies that are to be used in enzyme immunoassays. It covers the general requirements, the testing process and how the results are presented, and applies to the quality control of the antibodies themselves; enzyme-labelled antibodies are outside its scope.
Its terms section defines antibody (immunoglobulin), antigen, species source host, antibody type - with the five heavy-chain classes giving IgM, IgG, IgA, IgD and IgE - and titer, usually expressed as the highest dilution that still gives a positive result.
The work relies on laboratory water to GB/T 6682, biosafety to GB 19489 and the air cleanliness classes of GB/T 25915.1. It was issued on 21 May 2021 and has applied since 1 December 2021.
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Document preview — GB/T 40265-2021
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- A 40
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
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" Drafting.
1 Scope
This document specifies the general requirements, testing process and result presentation of enzyme immunoassay antibody testing.
This document is applicable to the detection control of antibodies for enzyme immunoassay.
This document does not apply to the detection control of labeled antibodies for enzyme immunoassay.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB 19489 Laboratory Biosafety General Requirements
GB/T 25915.1 Clean room and related controlled environment Part 1: Air cleanliness grade
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Antibody; immunoglobulin
Under the stimulation of antigens, the body's immune system proliferates and differentiates into plasma cells and produces a type that can specifically bind to the corresponding antigen. And mediate the production of humoral immune effects of globulin.
3.2 Antigen
Substances that can induce organisms to produce antibodies can be recognized by the corresponding antibodies and bind to them.
3.3 Species source host
The animal species used for immunization to prepare the antibody or the animal species whose amino acid sequence of the antibody constant region is closest to the antibody to be analyzed.
3.4 Antibody type
According to the structure and immunogenicity of antibodies, the classification of antibodies.
Note: Antibody heavy chains can be divided into five categories. mu, gamma, alpha, delta, and epsilon. Antibody light chains can be divided into two types. kappa and lambda. The type of antibody heavy chain determines the type of antibody, the mammalian body The antibodies in it include five types. IgM, IgG, IgA, IgD and IgE, corresponding to the antibody heavy chains mu, gamma, alpha, delta, and epsilon respectively.
3.5 Titer
The minimum concentration required for a certain antibody to recognize a specific antigen.
Note: The antibody titer is usually expressed by the highest dilution of the antibody when the test result is positive.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB 19489-2008 — Laboratories - General requirements for biosafety
GB/T 25915.1-2021 — Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
GB/T 25915.10-2021 — Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
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GB/T 40265-2021
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