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GB/T 41908-2022: Collection and processing of human feces biomaterial
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Collection and processing of human feces biomaterial
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GB/T 41908-2022
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Basic data | Standard ID | GB/T 41908-2022 (GB/T41908-2022) | | Description (Translated English) | Collection and processing of human feces biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C04 | | Word Count Estimation | 14,196 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 41908-2022: Collection and processing of human feces biomaterial---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.
Collection and processing of human feces biomaterial
ICS 07.080
CCSC04
National Standards of People's Republic of China
Human Fecal Sample Collection and Processing
Published on 2022-10-12
2022-10-12 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 General Requirements 2
5 Preparation before collection 2
5.1 Sample collection plan formulation 2
5.2 Informed Consent2
5.3 Pre-collection communication 2
6 Sample and Data Collection 3
6.1 General 3
6.2 Sample Collection Step 3
6.3 Data collection method and content 4
7 Sample and data processing 4
7.1 Sample Processing 4
7.2 Data processing process 4
7.3 Validation and validation of sample handling methods 4
7.4 Quality Control 5
Appendix A (normative) Choice of fecal sample preservation method 6
Appendix B (Informative) Methodological Validation Example 7
Reference 8
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 is drafted by. Guangdong Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine), Shanghai Biochip Co., Ltd., Sichuan University
Learn from West China Hospital, China Institute of Metrology, China National Accreditation Service for Conformity Assessment, Foshan Fosun Chancheng Hospital, Kangmei Huada Gene Technology
Technology Co., Ltd., The First Affiliated Hospital of Guangzhou Medical University, Shanghai Xinchao Biotechnology Co., Ltd., General Hospital of the Chinese People's Liberation Army, Chinese Medical
Peking Union Medical College Hospital, Guangzhou Women's and Children's Medical Center, Beijing Anzhen Hospital Affiliated to Capital Medical University, Shenzhen Huada Life Sciences
Research Institute, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Beijing Friendship Hospital Affiliated to Capital Medical University, Sun Yat-Sen University Cancer Center
Heart, First Affiliated Hospital of Sun Yat-sen University, Zhujiang Hospital of Southern Medical University, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Third Affiliated Hospital of Sun Yat-sen University
Hospital, Zhongshan Hospital Affiliated to Fudan University, Fudan University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Cancer Hospital Affiliated to Fudan University,
Tianjin Medical University Cancer Hospital, Shanghai Fourth People's Hospital Affiliated to Tongji University, Zhejiang Cancer Hospital, First Affiliated to University of Science and Technology of China
Hospital, Zhejiang Taizhou Hospital, Huazhong University of Science and Technology Union and Shenzhen Hospital.
The main drafters of this document. Chen Qubo, Gao Hengjun, Huang Wei, Lu Xinyi, Wang Jing, Zhang Xiaoyan, Li Junyan, Zeng Chijia, Jiang Xuanting, Zeng Xuan,
Zhang Yong, Sun Baoqing, Zhao Xiumei, Guo Dan, Gu Xiaoqiong, Zeng Xiaoli, Li Qiyuan, Kang Xiaonan, Zhang Yun, Jia Weihua, Ke Zunfu, Sun Haitao, Yang Songran,
Han Xiaoyan, Li Ka, Yang Yajun, Wang Weiye, Sun Menghong, Li Haixin, Man Qiuhong, Zheng Zhiguo, Ye Qing, Lin Aifen, Wang Chuyang, Huang Xiaoting.
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.
It is necessary to provide high-quality stool samples and standardized relevant data for scientific research.
Human Fecal Sample Collection and Processing
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 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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