GB/T 41908-2022Collection and processing of human feces biomaterial (English PDF)
人类粪便样本采集与处理
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
October 12, 2022
Implementation date
October 12, 2022
Scope
GB/T 41908-2022 is the English-translated version of 人类粪便样本采集与处理.
GB/T 41908-2022 tells biobanks how to collect and process human fecal samples for clinical and basic medical research.
It sets general requirements, then the preparation before collection - the collection plan, informed consent and pre-collection communication - the sample and data collection steps, the data to be recorded, sample and data processing, validation of the processing methods and quality control, with a normative annex on choosing the preservation method.
It defines feces and the preservation-solution stabilizer, whose job is to fix the microorganisms and protect DNA. It is written for biobanks, their users and regulators, peer-review bodies and accreditation agencies, and it does not cover fecal or anal-swab samples taken by clinical institutions for diagnosis, observing treatment effect or therapy. Issued on 12 October 2022, it has applied since the same date.
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Document preview — GB/T 41908-2022
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- C 04
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General Requirements
- 5 Preparation before collection
- 5.1 Sample collection plan formulation
- 5.2 Informed Consent
- 5.3 Pre-collection communication
- 6 Sample and Data Collection
- 6.1 General
- 6.2 Sample Collection Step
- 6.3 Data collection method and content
- 7 Sample and data processing
- 7.1 Sample Processing
- 7.2 Data processing process
- 7.3 Validation and validation of sample handling methods
- 7.4 Quality Control
- Appendix A (normative) Choice of fecal sample preservation method
- Appendix B (Informative) Methodological Validation Example
- Reference
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
Human biological samples are an important bridge between human disease clinical and basic translational medical research, and are a non-renewable resource for precision medicine research.
Biological sample preservation activities include the collection/collection, acquisition and receipt, recording, registration, cataloguing/classification, inspection, Processes such as preparation, preservation, storage, data management, destruction, packaging, and safety protection, distribution and transportation, and conduct samples in a standardized manner Collection, processing, transportation, storage, retrieval and inquiry are the fundamental guarantees for the correct use and sharing of biological sample resources. as biological samples The standardization of the collection and processing of biological samples and their related data is very important.
Compared with feces (anal swabs) collected by clinical medical institutions for disease diagnosis and curative effect observation, the fecal samples of biobanks and their related The data collection and processing procedures are significantly different. Before collecting fecal samples, biobanks need to pass strict ethical review.
Sign an informed consent form with the provider; after the fecal samples and their related data are collected, the sample bank will temporarily store, transport (transmit), process and store them There are a series of quality control procedures for the storage and other processes. Based on this, a specification for the collection and processing of human fecal samples in biobanks was established, which is a guide for medical sciences.
1 Scope
This document specifies general requirements for the collection and processing of human fecal samples, as well as preparation before collection, sample and data collection, sample and Data processing requirements and methods.
This document is applicable to the collection and processing of human fecal samples for clinical and basic medical research involved in biobanking. faecal-like collection and preservation institutions (biobanks), biobank users, biobank regulators, peer review organizations, biological samples This library is used for reference by quality and competence accreditation agencies.
This document does not apply to feces (anal swabs) conducted by clinical medical institutions for clinical diagnosis of diseases, observation of curative effects and for therapeutic purposes Collection and processing of samples.
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 19489 General Requirements for Laboratory Biosafety
GB/T 37864 General Requirements for the Quality and Capability of Biobanks
WS/T 313 Practice for hand hygiene of medical personnel
3 Terms and Definitions
GB/T 37864 and the following terms and definitions apply to this document.
3.1 Feces
Food that passes through the large intestine from the digestive tract and is excreted from the anus in solid, semi-fluid or fluid form and is not absorbed by the human body residue.
Note 1. Fecal/anal swab samples collected for clinical diagnostic purposes are mainly used for routine testing, parasite testing, chemical testing and bacterial testing.
Note 2. Standardized fecal samples donated from healthy people collected for clinical treatment are mainly used for fecal bacteria transplantation.
Note 3. Fecal samples collected for clinical research and basic medical research are mainly used for gastrointestinal microecological research (such as intestinal flora), non-targeted metabolism Omics research (such as short-chain fatty acids), fecal human cell research (such as early tumor screening), etc.
3.2 Preservation solution stabilizer
stabilizer Chemical reagents that stabilize the solid phase or nucleic acid material of fecal microorganisms.
Note: The main function of the preservation solution.
a) Fix microorganisms, so that microorganisms cannot continue to grow and change, and related proteases are inactivated;
b) Protect deoxyribonucleic acid (DNA) and stabilize DNA so that it is not easy to degrade and mutate.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB 19489-2008 — Laboratories - General requirements for biosafety
GB/T 37864-2019 — General requirements of quality and competence for biobank
WS/T 313-2009 — Specification of hand hygiene for healthcare workers
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