GB/T 40664-2021 English PDF

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GB/T 40664-2021: General requirements for high-throughput sequencing technologies of detecting nucleic acid samples
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Basic data

Standard ID: GB/T 40664-2021 (GB/T40664-2021)
Description (Translated English): General requirements for high-throughput sequencing technologies of detecting nucleic acid samples
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C04
Word Count Estimation: 13,145
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 40664-2021: General requirements for high-throughput sequencing technologies of detecting nucleic acid samples

---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.
General requirements for high-throughput sequencing technologies of detecting nucleic acid samples ICS 07.080 CCSC04 National Standards of People's Republic of China Nucleic acid samples for high-throughput sequencing General requirements for quality control Released on 2021-10-11 2022-05-01 implementation State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee

Table of contents

Foreword Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Quality control requirements 2 4.1 General requirements 2 4.2 Quality requirements for genomic DNA and nucleic acid samples 3 4.3 Quality requirements for total RNA and nucleic acid samples 3 5 Quality inspection method 3 5.1 Main equipment and instruments 3 5.2 Nucleic acid sample quality inspection method 4 Appendix A (informative) Sample integrity test of nucleic acid samples Figure 5

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" Drafting. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed and managed by the National Standardization Technical Committee for Biological Samples (SAC/TC559). Drafting organizations of this document. Shenzhen Huada Institute of Life Sciences, China Institute of Metrology, Shenzhen Huada Intelligent Manufacturing Technology Co., Ltd. Division, Qingdao Huada Gene Research Institute, Shenzhen Huada Gene Co., Ltd., Shanghai Biochip Co., Ltd., Second Attachment of Guangzhou University of Chinese Medicine A hospital (Guangdong Provincial Hospital of Traditional Chinese Medicine), Hubei International Travel Health Care Center (Wuhan Customs Port Clinic). The main drafters of this document. Zhu Zhenzhen, Wang Jing, Su Xiaoshan, Geng Chunyu, Li Qianyi, Chen Fang, Liu Xin, Xie Zeyu, Chen Li, Niu Chunyan, Huang Xiang, Zhang Xiaoyan, Xu Jingman, Chen Qubo, Gong Rui, Wang Peng, Zhou Yan, Sun Jing, Zeng Xuan.

Introduction

With the continuous development and wide application of high-throughput sequencing technology, more and more types of nucleic acid samples are used for high-throughput sequencing. The molecular level of DNA and RNA to reveal the differences in nucleic acid sequences between different species, as well as specific biological processes and disease processes Molecular mechanism. Since the quality of nucleic acid samples will have a direct impact on the data results of high-throughput sequencing, it is formulated for high-throughput testing. The general requirements for the quality control of sequenced nucleic acid samples are particularly urgent and important, so as to ensure that the nucleic acid samples for high-throughput sequencing can meet the requirements. The quality of the target, and then reliable sequencing data can be obtained to avoid the occurrence of information errors and information loss. This document is formulated based on the application of high-throughput sequencing technology and verification data. In order to improve the success rate and accuracy of sequencing, it has played an important role in regulating the entire high-throughput sequencing market. Nucleic acid samples for high-throughput sequencing General requirements for quality control

1 Scope

This document specifies general requirements for quality control of genomic DNA and total RNA nucleic acid samples used for high-throughput sequencing, including Terms and definitions of sample testing, quality control requirements, and quality testing methods. This document is applicable to eukaryotes and organisms extracted from fresh blood, saliva, animal and plant tissues, cell culture fluids, and bacterial fluids. Genomic DNA and total RNA samples of nuclear organisms.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. GB/T 30989 Technical Regulations for High-throughput Gene Sequencing GB/T 35537 High-throughput gene sequencing results evaluation requirements GB/T 37864 General Requirements for the Quality and Capability of Biological Sample Banks

3 Terms and definitions

The following terms and definitions defined in GB/T 30989 and GB/T 35537 apply to this document. 3.1 Deoxyribonucleic acid deoxyribonucleic acid; DNA Biological macromolecules with genetic information. It consists of four main deoxynucleotides (deoxy adenine monophosphate dAMP, deoxy monophosphate Guanine dGMP, deoxycytosine monophosphate dCMP and deoxythymine monophosphate dTMP) are connected by 3',5'-phosphodiester bonds Become. Note. Their composition and arrangement are different, showing different biological functions, such as. coding function, copy and transcription regulation functions. 3.2 Ribonucleic acid;RNA A type of nucleic acid. A polymer composed of nucleotides connected by 3',5'-phosphodiester bonds. Note. Different types of RNA have different chain lengths and perform various biological functions. For example, RNA related to protein biosynthesis has messenger RNA (mes- sengerRNA, mRNA), transfer RNA (transferRNA, tRNA) and ribosomal RNA (ribosomeRNA, rRNA); and post-transcriptional addition Work-related RNAs include small nuclear RNA (smalnuclearRNA, snRNA), small nucleolar RNA (smalnucleolarRNAs, snoRNAs); and The RNAs related to biological regulation include microRNAs (miRNAs), small interfering RNAs (smalinterferingRNAs, siRNAs) and so on. 3.3 Ribosomal RNA ribosomeRNA; rRNA One of the main ribonucleic acids in biological cells is a ribozyme with catalytic ability. Note. When it exists alone, it cannot function like other ribonucleic acids. It only forms a ribosome (a type of membraneless cell It is the highest content of RNA before it can perform its function. There are three types of rRNA contained in the ribosomes of prokaryotes. 5S, 16S and 23S. real ......

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