GB/T 40664-2021General requirements for high-throughput sequencing technologies of detecting nucleic acid samples (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" Drafting.

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.

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.