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GB/T 41698-2022 English PDF

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GB/T 41698-2022: Detection of extraneous viruses in biological products derived from duck
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Standard similar to GB/T 41698-2022

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Basic data

Standard ID GB/T 41698-2022 (GB/T41698-2022)
Description (Translated English) Detection of extraneous viruses in biological products derived from duck
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard B41
Classification of International Standard 11.220
Word Count Estimation 18,167
Date of Issue 2022-10-14
Date of Implementation 2023-05-01
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 41698-2022: Detection of extraneous viruses in biological products derived from duck

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Detection of extraneous viruses in biological products derived from duck ICS 11.220 CCSB41 National Standards of People's Republic of China Detection method of foreign virus in duck-derived biological products Published on 2022-10-12 2023-05-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions, Abbreviations 1 4 Preparation and collection of immune serum 2 5 Antibody Detection 2 5.1 Duck plague virus (DPV) ELISA antibody detection 2 5.2 Duck hepatitis virus type I (DHVI) neutralization test 4 5.3 Duck Tembusu virus (DTMUV) hemagglutination inhibition test 5 5.4 Duck Tembusu virus (DTMUV) ELISA antibody detection 7 5.5 Muscovy duck parvovirus (MPV) latex agglutination inhibition test 9 5.6 Muscovy duck gosling plague virus (GPV) latex agglutination inhibition test 11 6 Comprehensive determination of foreign virus test results 13 Appendix A (Normative) Solution Preparation 14

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. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the National Technical Committee on Standardization of Inspection Methods for Key Products of Quality Supervision (SAC/TC374). This document is drafted by. China Veterinary Drug Administration. The main drafters of this document. Zhao Yun, Wang Fang, Teng Ying, Meng Jie, Zheng Cunzhe, Wang Xiaolei, Li Zejun, Liu Yuehuan, Chen Shaoying, Gong Xiao, Qu Hongfei, Yang Chenghuai, Yang Xiaoyue, Xue Feng, Chen Dongyang.

Introduction

The number of duck breeding in my country ranks first in the world. In recent years, the epidemic of ducks has increased, and the variety of duck-derived biological products produced and used has increased. many. Exogenous virus inspection is one of the quality control items of live virus vaccines, which is very important to ensure product quality. "Chinese Veterinary Pharmacopoeia" (2020 The relevant methods and standards for the detection of exogenous viruses in poultry-derived biological products in the Appendix) are mainly for chicken-derived or chicken-derived products, lacking duck-derived It is difficult to objectively evaluate product quality because of the relevant methods and standards of physical products. This document draws on international advanced experience and focuses on exogenous diseases of duck-derived biological products The key parameters of virus detection, the current status of the main epidemic duck virus diseases and the research maturity of detection methods, the formulation of duck plague virus, duck hepatitis disease Chicken detection method for 5 kinds of viruses, including virus type I, duck Tembusu virus, Muscovy duck parvovirus, and Muscovy duck gosling plague virus. Detection method of foreign virus in duck-derived biological products

1 Scope

This document describes the use of chickens for duck plague virus, duck hepatitis virus type I, duck Tembusu virus, Muscovy duck parvovirus, Muscovy duck gosling plague virus A method for the detection of foreign viruses in duck-derived biological products. This document is applicable to the detection of foreign viruses in duck-derived biological products (live vaccines and production virus seeds).

2 Normative references

There are no normative references in this document. 3 Terms and Definitions, Abbreviations 3.1 Terms and Definitions The following terms and definitions apply to this document. 3.1.1 Using natural or artificially modified duck-derived microorganisms, parasites, biological toxins or duck-derived biological tissues and metabolites as materials, using raw materials Products made by biology, molecular biology or biochemistry, bioengineering and other corresponding technologies for the prevention, treatment and diagnosis of duck blight. 3.1.2 live vaccines livevaccines Vaccines derived from field attenuated strains or attenuated strains obtained by physical, chemical or biological attenuating methods and prepared by culture and propagation. 3.1.3 Poison Seed It has a certain number, clear background, single composition, good immunogenicity and reproductive characteristics after systematic identification, biological characteristics and identification characteristics Definite, pure viruses used in the development, production and testing of veterinary biological products. 3.1.4 A type of inspection for products that may be contaminated by exogenous viruses due to production processes, raw and auxiliary materials, etc. 3.1.5 Under the rearing conditions of barrier environment or isolated environment, it does not contain Salmonella pullorum, Haemophilus paragallina, Pasteurella multocida, chicken Mycoplasma viremia, Mycoplasma synovium, avian influenza virus, Newcastle disease virus, infectious bronchitis virus, infectious bursal disease virus, infectious Laryngeal tracheitis virus, lymphoid leukemia virus, reticuloendotheliosis virus, Marek's disease virus, chicken infectious anemia virus, avian reovirus Virus, avian encephalomyelitis virus, avian adenovirus group III, avian adenovirus group I, fowl pox virus and other 19 specific pathogenic microorganisms, which can be used for microorganisms Learn to monitor chickens. 3.2 Abbreviations The following abbreviations apply to this document.

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