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GB/T 45106-2024 PDF English

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GB/T 45106-2024: Diagnostic technique of leptospirosis in animals
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Basic data

Standard ID GB/T 45106-2024 (GB/T45106-2024)
Description (Translated English) Diagnostic technique of leptospirosis in animals
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard B41
Classification of International Standard 11.220
Word Count Estimation 22,258
Date of Issue 2024-12-31
Date of Implementation 2025-07-01
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 45106-2024: Diagnostic technique of leptospirosis in animals


---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 Standard of the People's Republic of China Diagnostic technology of animal leptospirosis Released on 2024-12-31 2025-07-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Abbreviations 1 5 Clinical diagnosis 1 5.1 Epidemiology 1 5.2 Clinical symptoms 2 5.3 Routine laboratory tests 2 5.4 Autopsy changes 2 5.5 Result determination 2 6 Biosafety Requirements 2 7 Sample collection and storage 3 7.1 Sample Collection 3 7.2 Sample Storage 3 8 Isolation, culture and identification 3 8.1 Equipment 3 8.2 Reagents 3 8.3 Sample processing and culture 3 8.4 Result determination 3 9 PCR 4 9.1 Equipment 4 9.2 Reagents 4 9.3 DNA extraction 4 9.4 Primer 4 9.5 Amplification System 4 9.6 Amplification Procedure 4 9.7 Electrophoresis detection of amplified products 5 9.8 Experimental conditions 5 9.9 Result determination 5 10 MAT 5 10.1 Equipment 5 10.2 Reagents 5 10.3 Qualitative test 5 10.4 Quantitative test 6 10.5 MAT result determination 7 11 Comprehensive judgment 7 12 Differential diagnosis 7 Appendix A (Normative) Preparation of Reagent Solution 8 A.1 EMJH medium 8 A.2 50×TAE stock solution 8 A.3 1% agarose gel 9 A.4 PBS buffer 9 Appendix B (Informative) Primer Instructions 10 Appendix C (Informative) Preparation of Standard Antigens and Positive Serum for Each Serogroup 11 C.1 Preparation of standard antigens for each serogroup 11 C.2 Preparation of standard positive serum for each serogroup 11 Appendix D (Informative) MAT result determination diagram 13 Appendix E (informative) Differential diagnosis of leptospirosis 16 E.1 Canine parvovirus disease16 E.2 Canine distemper16 E.3 Brucellosis in cattle, sheep and pigs16 Reference 17

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 for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document was 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 Technical Committee on Animal Health Standardization (SAC/TC181). This document was drafted by. Jilin University, Jilin Provincial Animal Disease Prevention and Control Center, Nanchang Police Dog Base of the Ministry of Public Security, Changchun Sino Biological Science Technology Co., Ltd., Shanghai Jilin Biotechnology Co., Ltd., Beijing Zhongke Gene Technology Co., Ltd., Qingdao Lijian Biotechnology Co., Ltd. Co., Ltd., Durbert Mongolian Autonomous County Animal Husbandry Technology Service Center, and Shenzhen Aodong Inspection and Testing Technology Co., Ltd. The main drafters of this document are. Cao Yongguo, Zhang Wenlong, Xie Xufeng, Yu Qinlei, Xu Li, Liu Zhanbin, Liu Wei, Li Jie, Zhang Miaojie, Lin Yu, Sun Xueqiang, Huang Xianye and Zhang Li.

Introduction

Leptospirosis (Leptospirosis) is caused by pathogenic Leptospira (Leptospira) A widely spread natural zoonotic infectious disease. When pigs, horses, cattle, sheep, dogs, cats and humans are infected with Leptospira, they will show Symptoms such as jaundice, miscarriage, liver and kidney failure, and even death have seriously endangered the development of animal husbandry and public health safety. It is a Class III animal infectious disease. Animal leptospirosis occurs all year round, with the peak of epidemic in summer and autumn. The early symptoms of leptospirosis are not obvious and can be easily confused with other diseases. Laboratory testing is required to confirm the diagnosis of leptospirosis. Laboratory tests include pathogen detection and antibody detection. Common pathogen detection methods include isolation and culture and polymerase chain reaction (PCR). Common methods for detecting leptospira antibodies include enzyme-linked immunosorbent assay (ELISA) and microscopic agglutination test (MAT). It is necessary to prepare enzyme-labeled secondary antibodies for the animals to be tested. However, this document involves many animal species, so the pathogen detection in this document adopts isolation, culture and PCR method was used, and MAT method was used for antibody detection, and ELISA method was cancelled. This document refers to some chapters given in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organization for Animal Health (WOAH) and is Under the guidance of the "Three Animal Disease Prevention and Control Standards", combined with the new research results of relevant technologies in my country, the technology is in line with international advanced technology. Consistent. Diagnostic technology of animal leptospirosis

1 Scope

This document specifies the comprehensive technical requirements for the determination of animal leptospirosis, and describes the clinical diagnosis, isolation and culture identification, polymerase chain reaction And the operation methods of microscopic agglutination experiment. This document applies to the clinical diagnosis, laboratory testing, epidemiological investigation, and inspection and quarantine of animal leptospirosis.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 19489 General requirements for laboratory biosafety NY/T 541 Technical Specification for Collection, Storage and Transportation of Veterinary Diagnostic Samples

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 Abbreviations

The following abbreviations apply to this document.

5 Clinical diagnosis

5.1 Epidemiology 5.1.1 Susceptible animals Animals such as pigs, horses, cattle, sheep, dogs, and cats can be infected. 5.1.2 Source of infection Wild rodents and marsupials are the main sources of infection for leptospirosis. Other animals can also be sources of infection, such as pigs, cattle, sheep, dogs, Arthropods and frogs. 5.1.3 Transmission routes Some wild rodents do not show clinical symptoms after being infected with Leptospira, but a large number of Leptospira will colonize in their kidneys.
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