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GB/T 41895-2022Determination for DNA viruses of cell—MNP marker method (English PDF)

细胞中DNA病毒测定 MNP标记法

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 12, 2022

Implementation date

October 12, 2022

Scope

GB/T 41895-2022 is the English-translated version of 细胞中DNA病毒测定 MNP标记法.

GB/T 41895-2022 is the Chinese national method for determining DNA viruses in cells by MNP - multi-nucleotide polymorphism - markers.

Clause 1 says it describes the reagents or materials, the equipment, the measurement procedure, the quality control, the calculation and presentation of results, and the anti-contamination and biosafety measures, and that the method it specifies has a limit of detection of 10 copies per reaction for a single virus.

The viruses in its field of application begin with adenovirus, Epstein-Barr virus, varicella-zoster virus, cytomegalovirus and herpes simplex virus type 1, and the list runs on past the end of the preview.

Clause 3 defines the target pathogen, internal control DNA, the MNP polymorphism over a nucleotide sequence not exceeding 300 bp, and the marker site. Issued on 12 October 2022, it has applied since the same date.

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Document preview — GB/T 41895-2022

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" drafted.

Certain contents of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.

1 Scope

This document describes reagents or materials for the determination of DNA (deoxyribonucleic acid) viruses in samples by MNP (polynucleotide polymorphism) labeling materials, equipment, measurement procedures, quality control, calculation of results and presentation of results, anti-pollution measures and biosafety measures.

This document applies to adenovirus (Adenovirus, AdV), Epstein-Barrvirus (Epstein-Barrvirus, EBV), varicella-zoster disease virus (Varicela-zostervirus, VZV), cytomegalovirus (Cytomegalovirus, CMV), herpes simplex virus type 1 (Herpes The method specified in this document has a limit of detection (LOD) of 10 copies/reaction for a single virus.

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

GB 19489 General Requirements for Laboratory Biosafety

GB/T 27403 Laboratory Quality Control Specification for Food Molecular Biology Testing

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Target pathogen

One or more DNA viruses to be assayed.

3.2 Internal control DNA

Synthetic DNA that has no homology with known biological genomes and has a definite copy number.

3.3 multiple nucleotide polymorphism

A polymorphism caused by multiple nucleotides in a nucleotide sequence not exceeding 300bp.

3.4 Marker site marker

A nucleotide sequence on the genome of the target pathogen that specifically identifies the target pathogen, and the nucleotide sequence is related to the target pathogen There is homology in the genome, and there is no homology with the genome of known organisms other than the target pathogen.

......
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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GB/T 41895-2022

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