GB/T 41910-2022 English PDF

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GB/T 41910-2022: Quality control of washed fecal microbiota and grading of fecal microbiota
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Basic data

Standard ID: GB/T 41910-2022 (GB/T41910-2022)
Description (Translated English): Quality control of washed fecal microbiota and grading of fecal microbiota
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C04
Classification of International Standard: 07.080
Word Count Estimation: 10,122
Date of Issue: 2022-10-14
Date of Implementation: 2022-10-12
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 41910-2022: Quality control of washed fecal microbiota and grading of fecal microbiota

---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.
Quality control of washed fecal microbiota and grading of fecal microbiota ICS 07.080 CCSC04 National Standards of People's Republic of China Quality control of washed fecal bacteria and grading of fecal bacteria samples Published on 2022-10-12 2022-10-12 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 1 4 General Requirements 2 5 Washing fecal bacteria quality control 2 5.1 Basic requirements 2 5.2 Fecal collection 2 5.3 Fecal bacteria isolation 2 5.4 Fecal bacteria rinse 2 5.5 Preparation time limit 3 5.6 Fecal bacteria measurement 3 5.7 Frozen fecal bacteria 3 5.8 Fecal bacteria markers 3 5.9 Safety Quality Control 3 5.10 Fecal bacteria transport 3 5.11 Fecal bacteria rewarming 3 6 Classification of fecal bacteria samples 3 Appendix A (Informative) Experimental Equipment, Instruments, Carrier Liquid, Protective Agent, and Alternative Disinfectant 5 Reference 6

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 Standardization Technical Committee of Biological Samples (SAC/TC559). This document was drafted by. Shanghai Biochip Co., Ltd., Second Affiliated Hospital of Nanjing Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine (Guangzhou Traditional Chinese Medicine) The Second Affiliated Hospital of the University), China Institute of Metrology, Shanghai Xinchao Biotechnology Co., Ltd., Chinese Center for Disease Control and Prevention Viral Disease Prevention Control. The main drafters of this document. Zhang Fafang, Chen Qubo, Gao Hengjun, Wang Jing, Li Pan, Zhang Xiaoyan, Xin Li.

Introduction

The technique of reconstructing the gut microbiome using human fecal-derived microbiota is called fecal microbiota transplantation. as a treatment for human diseases Fecal microbiota transplantation has become the medical guideline or expert consensus and recommended treatment method in China, the United States, Australia, the United Kingdom, France and other countries. For the treatment of refractory Clostridium difficile infection, it is also used worldwide in inflammatory bowel disease, irritable bowel syndrome, constipation, graft-versus-host Exploratory clinical research on diseases related to intestinal flora dysbiosis, such as autism, autism, and intestinal-related epilepsy. As an animal research technique, fecal bacteria transfer Plants have been widely used in animal studies of microbiome technology. The preparation method of fecal bacteria samples is a key factor in determining the effect, safety and reproducibility of the results. It is difficult to prepare fecal bacteria and their suspensions by manual methods. Quantification and quality control also lack operational efficiency and humanization. Clinical research and animal experimental research reports have proved that based on the intelligent fecal bacteria separation system and The sample quality and classification of the washing process control can play a role in quantification, quality control and greatly improve safety. In.2019, the "Washing "Nanjing Consensus on the Methodology of Polyester Transplantation", to promote the standardization of fecal microbiota transplantation and enter the stage of washing microbiota transplantation. Develop laboratory operating standards It can help reduce adverse events related to fecal microbiota transplantation and improve the acceptance of fecal microbiota transplantation by patients and medical technicians. Helps to improve the reproducibility of clinical and animal research results by quantifying the number of bacteria administered, and to ensure the biological application of the bacterial colony transplantation technology. Safety and Quality Control. Quality control of washed fecal bacteria and grading of fecal bacteria samples

1 Scope

This document specifies the separation and purification of fecal material derived from donor feces under clean laboratory conditions of biosafety level 2 and above. Basic operating requirements for bacterial samples. This document applies to the preparation, washing and purification of fecal bacteria samples performed in the clean laboratory of a state-approved hospital.

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 18467-2011 Requirements for health examination of blood donors GB 19489-2008 General requirements for laboratory biosafety GB/T 37864-2019 General requirements for the quality and capacity of biobanks GB 50457-2019 Design standards for clean workshops in the pharmaceutical industry

3 Terms and Definitions

The terms and definitions defined in GB/T 37864-2019 and the following terms and definitions apply to this document. 3.1 Used to guide and standardize laboratory protection, laboratory biosafety levels, equipment and facilities, fecal bacteria separation and quality control, fecal bacteria storage, etc. A program that works throughout the entire process. 3.2 Donor Healthy donors or autologous transplant donors who meet the fecal donor screening criteria for FMT. Healthy donors are GB 18467-2011, Adolescents and children under the age of 24, and there is no candidate for any of the following. definite or suspicious bacterial, fungal, virus and other microbial infections; history of gastrointestinal polyps; abnormal defecation habits and shape; defecation volume less than 50g/time; skin Rough skin, abnormal skin luster, or acute or chronic skin diseases; antibiotic users within 3 months; body mass index exceeding the healthy range (overweight or Weight loss); sexual life history within 3 months; unreasonable diet; smoking habit, drinking habit and tattooing; unsatisfactory life and rest Sufficient sleep at night; definite or suspected abnormal mental health; living or working in a high temperature, high pollution risk environment; with tumors, metabolic Family history of sexually transmitted diseases and psychiatric disorders. [Source. GB/T 37864-2019, 3.22, with modifications] 3.3 Fecal microbiota Gut microbiota (or gut microbiota) isolated from donor stool samples. 3.4 Through the automatic fecal bacteria separation system, the sterile carrier solution is automatically injected, stirred and mixed, hierarchical filtration, deodorization, etc., to effectively remove the fecal bacteria. ......

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