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GB/T 41234-2022Specification of quality control of reference materials for RNA virus detection of aquatic animals—Armored RNA (English PDF)

水生动物RNA病毒核酸检测参考物质质量控制规范 假病毒

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 9, 2022

Implementation date

October 1, 2022

Scope

GB/T 41234-2022 is the English-translated version of 水生动物RNA病毒核酸检测参考物质质量控制规范 假病毒.

GB/T 41234-2022 sets the quality control specification for armored RNA, the pseudovirus used as a reference material when RNA viruses of aquatic animals are detected.

It gives the terms and definitions, the abbreviations, the principle, the reagents or materials and the instruments, and then the quality control of the pseudovirus, its preservation, its verification and the method by which its quality is assessed.

It applies to the quality control of armored RNA reference materials used in the detection of RNA viruses in aquatic animals. Fishery disease laboratories, quarantine bodies and the producers of reference materials use it. Issued on 9 March 2022, it has applied since 1 October 2022.

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Document preview — GB/T 41234-2022

National Standard of the People's Republic of China

ICS
65.020.30
Classification
B 41

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" drafted.

1 Scope

This document presents the terminology and definition of pseudoviruses used as reference materials for the detection of RNA virus nucleic acids in aquatic animals, and their quality control specifications.

Definitions, acronyms, principles, reagents or materials, instruments and equipment, specifies the quality control of pseudoviruses, the preservation of pseudoviruses, the verification of pseudoviruses, and Pseudovirus quality assessment method.

This document is applicable to the quality control of pseudovirus (armored RNA) reference materials in the detection of RNA viruses in aquatic animals.

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 6682 Analysis Laboratory Water Specifications and Test Methods

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Coefficient of variation

A normalized measure of the degree of dispersion of a probability distribution, which is defined as the ratio of the standard deviation of the data to the mean of the data.

3.2 Initial sample frontsample

According to the order of preparation, the first 1/3 batch of products are prepared.

3.3 Pseudovirus armoredRNA

Virus-like particles formed by encapsulating segments of viral RNA with outer membrane proteins.

3.4 Uniformity

Pseudoviruses from the same production batch, each containing the same amount of target gene.

3.5 Traceability

The identity of the target gene sequence in the pseudovirus and the sequence of the pathogen reference strain.

3.6 Stability

Pseudoviruses have the ability to ensure positive test results within specific storage conditions and storage time ranges.

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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.

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