GB/T 45633-2025Collection and processing of human saliva biomaterial (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 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 and coordinated by the National Technical Committee on Biological Sample Standardization (SAC/TC559).

This document was drafted by: Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Peking University Stomatological Hospital, Capital Medical University Beijing Stomatological Hospital, Shanghai Xinchao Biotechnology Co., Ltd., West China Hospital of Stomatology, Sichuan University, PLA Air Force Medical University Third Affiliated Hospital, Affiliated Stomatological Hospital of Chongqing Medical University, Fudan University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Guangzhou University of Chinese Medicine), Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Cancer Hospital Affiliated to Fudan University, Shanghai Guo International Human Phenotype Group Research Institute, Stomatological Hospital of Sun Yat-sen University, Cancer Center of Sun Yat-sen University, Huashan Hospital of Fudan University, Wuhan University Shanghai University of Stomatology Hospital, Shanghai Yikang Medical Laboratory Co., Ltd., and Shanghai Clinical Research Center.

The main drafters of this document are: Li Jiang, Zhang Zhiyuan, Xu Feng, Wang Xueling, Chen Yueyao, Shi Huan, Zhang Qianqian, Hua Hong, Zheng Shuguo, Jin Luyuan, Jiang Lu, Zhang Xiaoyan, Shen Xuemin, Su Jiazeng, Lu Haixia, Niu Lina, Song Jinlin, Yang Yajun, Wang Weiye, Chen Qubo, Kang Xiaonan, Sun Menghong, Xu Midie, Guo Yunfeng, Xia Juan, Zheng Xiaohui, Zhong Laiping, Jia Weihua, Zhou Gang, He Yue, Jiang Yueming, Liang Wei.

Introduction

Human saliva is a physiological substance secreted by the salivary glands. It contains rich biological information and can reflect the state of the human body to a certain extent.

The relevant markers in human saliva samples are of great significance in disease detection. The collection of human saliva samples is simple, non-invasive, The technology has the advantages of low sensitivity, low cost, high efficiency, no restrictions on time and place, and easy acceptance by saliva sample providers.

Many scientific research units and large medical institutions in China need to collect human saliva samples for clinical and basic research.

There is currently no relevant national standard to regulate the collection and processing of saliva samples for various purposes.

This will result in uneven quality of saliva samples, making them unusable for subsequent research, causing serious waste of resources and affecting resource sharing.

Developing unified and standardized saliva sample collection and processing can identify and eliminate potential variability factors in the process, thereby improving the quality of saliva samples.

The quality of this research is beneficial to improving the consistency of the later research process and the reliability and accuracy of experimental data, which is of great significance to promoting the progress of scientific research and Optimization of clinical practice has far-reaching significance and value.

Human saliva sample collection and processing

1 Scope

This document specifies the general requirements for the collection and processing of human saliva samples, describing the pre-collection preparation, saliva sample collection, saliva sample Methods of processing and information collection of saliva samples.

This document applies to the collection and processing of human saliva samples for clinical and basic medical research involved in biobanks.

2 Normative references

GB/T 37864-2019

GB/T 38736

GB/T 43429

3 Terms and definitions

The terms and definitions defined in GB/T 37864-2019 and the following apply to this document.