GB/T 18639-2023 English PDF

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GB/T 18639-2023: Diagnostic techniques for rabies
Status: Valid

GB/T 18639: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 18639-2023	409	Add to Cart	4 days	Diagnostic techniques for rabies	Valid
GB/T 18639-2002	319	Add to Cart	3 days	Diagnostic techniques for rabies in animals	Obsolete

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GB/T 25165   NY/T 1663   GB/T 20365   GB/T 18646   GB/T 18649   

Basic data

Standard ID: GB/T 18639-2023 (GB/T18639-2023)
Description (Translated English): Numbering rules for labor and labor safety sector standards
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A24
Classification of International Standard: 01.120
Word Count Estimation: 8,899
Date of Issue: 2023-10-09
Date of Implementation: 2023-10-09
Issuing agency(ies): Ministry of Human Resources and Social Security
Summary: This standard specifies the numbering structure and numbering application of labor and labor safety industry standards. This document applies to the industry standard numbers managed by the Ministry of Human Resources and Social Security.

GB/T 18639-2023: Diagnostic techniques for rabies

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:220 CCSB41 National Standards of People's Republic of China Replace GB/T 18639-2002 Rabies Diagnostic Technology Published on 2023-11-27 2024-06-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee

Table of contents

PrefaceⅠ Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Abbreviations 1 5 Clinical Diagnosis 2 6 Sample collection, storage and transportation 2 7 Direct Immunofluorescence Assay (DFA) 3 8 Direct Rapid Immunohistochemistry Test (dRIT) 3 9 Nested RT-PCR Assay 5 10 Real-time fluorescence RT-PCR detection 6 11 Real-time fluorescent recombinase polymerase amplification (RT-RPA) detection 7 12 Cell culture virus isolation and detection 8 13 Isolation and detection of virus inoculated into mouse brain 10 14 Comprehensive judgment 10 Appendix A (Normative) Biosafety Measures for Rabies Diagnostic Testing 12 Appendix B (Normative) Reagent Preparation 13 Appendix C (informative) Rabies virus positive and negative brain tissue preparation 14 Appendix D (informative) For the real-time fluorescence RT-RPA detection and result judgment of rabies virus, refer to Figure 15

Foreword

This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting: This document replaces GB/T 18639-2002 "Rabies Diagnostic Technology": Compared with GB/T 18639-2002, except for structural adjustment and compilation In addition to editorial changes, the main technical changes are as follows: ---Changed the scope of application of various diagnostic methods listed in this document (see Chapter 1, Chapter 1 of the:2002 edition); ---Added abbreviations (see Chapter 4); --- Added clinical diagnosis (see Chapter 5); ---Deleted "Inspection of Endocardial Bodies" (see Chapter 2 of the:2002 edition); ---Added direct rapid immunohistochemical detection (see Chapter 8), nested RT-PCR detection (see Chapter 9), and real-time fluorescence RT-PCR 4 detection methods: detection (see Chapter 10) and real-time fluorescent recombinase polymerase amplification (RT-RPA) detection (see Chapter 11); ---Refining the detection operation into virus isolation and detection in cell culture and virus isolation and detection inoculated into the mouse brain (see Chapter 12, Chapter 13 Chapter, Chapter 4 of the:2002 edition); ---Added comprehensive judgment (see Chapter 14); --- Added biosecurity measures for rabies diagnostic testing (see Appendix A): Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents: This document is proposed by the Ministry of Agriculture and Rural Affairs of the People's Republic of China: This document is under the jurisdiction of the National Animal Health Standardization Technical Committee (SAC/TC181): This document was drafted by: Institute of Military Veterinary Medicine, Academy of Military Medicine, Academy of Military Sciences: The main drafters of this document: Hu Rongliang, Zhang Shoufeng, Miao Fafa, Chen Teng, Wang Xiaohu, Zhang Fei, Wang Ying, Luo Shengjun, Jiang Yiqian, and Mi Lijuan: The previous versions of this document and the documents it replaces are as follows: ---First published as GB/T 18639-2002 in:2002: ---This is the first revision:

Introduction

As a viral infectious disease with a case fatality rate of almost 100%, the final diagnosis of rabies relies on laboratory diagnostic technology: Since GB/T 18639-2002 was first promulgated, laboratory diagnostic technology for rabies has continued to develop: Based on direct immunofluorescence detection The antigen detection method of DFA has been determined as the "gold standard" by the World Health Organization (WHO) and the World Organization for Animal Health (WOAH); RT-PCR and real-time fluorescence RT-PCR technologies for infection diagnosis through specific amplification of viral nucleic acids are widely used; detection Rapid immunohistochemical detection of viral antigens in neural tissue (dRIT) is recommended by WHO; recombinase-polymerase amplification based on isothermal amplification Increased automation technology (RPA) has also been widely used in recent years: The above detection methods are in common with the virus isolation technology specified in GB/T 18639-2002: It has become a commonly used and reliable method for the current laboratory diagnosis of rabies, and is included in the WOAH "Terrestrial Animal Diagnostic Tests and Vaccines Manual" and Listed and recommended in WHO's "Laboratory Techniques for Rabies": At the same time, the method based on histopathological technology in Chapter 2 of GB/T 18639-2002 Negribodies examination has been gradually eliminated due to low sensitivity: my country's health and disease control, animal epidemic control, animal quarantine and scientific research institutions have simultaneously carried out research on the above-mentioned rabies laboratory diagnostic technology: At present, It has been widely used, and relevant equipment and supporting testing reagents are in stable supply: Based on the above progress, refer to WHO and WOAH recommended technology technology, GB/T 18639-2002 is revised based on the actual situation in my country and relevant research results, aiming to standardize the diagnosis of animal rabies in my country: and quarantine methods, improve detection levels to effectively guide the implementation of prevention and control measures, ensure the health and safety of humans and animals, and provide a basis for my country’s gradual realization of dog-borne transmission play an active role in the elimination of transmitted rabies: The nucleic acid amplification primers and probe sequences listed in this document were designed through comprehensive analysis of the sequences of domestic rabies epidemic strains: It has been obtained and verified by a large number of experiments, and its detection sensitivity and specificity are not lower than the primer and probe sequences recommended by international organizations: In addition, crazy The detection of canine neutralizing antibodies is an important means for evaluating animal immunity effects: It is usually not used for animal rabies diagnosis and is therefore not included in this document: Rabies Diagnostic Technology

1 Scope

This document describes the clinical diagnosis, sample collection, storage and transportation, direct immunofluorescence assay (DFA), direct immunofluorescence assay, and Rapid immunohistochemical test (dRIT), nested RT-PCR test, real-time fluorescent RT-PCR test, real-time fluorescent recombinase polymerase amplification Methods for RT-RPA detection, cell culture virus isolation and detection, mouse brain inoculation virus isolation and detection, and comprehensive judgment: This document is applicable to rabies diagnosis during animal quarantine, disease surveillance and epidemiological investigations:

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative citations in the text: Among them, dated references For referenced documents without dates, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document: document: GB/T 6682 Specifications and test methods for water used in analytical laboratories GB/T 34740-2017 Direct immunofluorescence diagnostic method for animal rabies

3 Terms and definitions

There are no terms or definitions to be defined in this document:

4 Abbreviations

The following abbreviations apply to this document: AEC:3-Amino-9-Ethylcarbazole (3-Amino-9-Ethylcarbazole) holequencher1) Ct: Cycle threshold (Cyclethreshold) DMF:N,N-Dimethylformamide (N,N-Dimethylformamide) FAM: Carboxyfluorescein fluorophoreFAM) ......

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