GB/T 41910-2022Quality control of washed fecal microbiota and grading of fecal microbiota (English PDF)

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.

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.

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.