GB/T 43279.2-2023 English PDF

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GB/T 43279.2-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 43279.2-2023	364	Add to Cart	4 days	Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA	Valid

Similar standards

GB/T 42061   GB/T 16886.9   GB/T 42062   GB/T 43278   GB/Z 43280   GB/T 43279.3   

Basic data

Standard ID: GB/T 43279.2-2023 (GB/T43279.2-2023)
Description (Translated English): Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.100.10
Word Count Estimation: 20,270
Date of Issue: 2023-11-27
Date of Implementation: 2024-06-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 43279.2-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

---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.
ICS 11:100:10 CCSC30 National Standards of People's Republic of China Molecular in vitro diagnostic test venous whole blood pre-test process Specification Part 2: Isolating Genomic DNA (ISO :20186-2:2019,IDT) Published on 2023-11-27 2024-06-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee

Table of contents

PrefaceⅠ Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General considerations 4 5 Outside the laboratory 5 5:1 Specimen collection 5 5:2 Shipping requirements 6 6 Inside the laboratory 7 6:1 Specimen Receipt 7 6:2 Storage requirements 7 6:3 Isolation of genomic DNA 8 6:4 Isolated genomic DNA content and quality assessment 8 6:5 Storage of isolated genomic DNA 9 Appendix A (informative) Impact of pre-test process steps on the quality of venous whole blood genomic DNA10 A:1 General information on test operations10 A:2 Effect of pre-test variables (blood storage time, temperature, DNA isolation method) on genomic DNA integrity10 A:3 Impact of genomic DNA integrity on detection based on long PCR amplicons11 A:4 Effect of blood storage time on genomic DNA integrity11 A:5 Effect of blood storage conditions on short amplicon-based PCR detection performance 12 Reference 14

Foreword

This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting: This document is Part 2 of GB/T 43279 "Specification for pre-examination process of venous whole blood for molecular in vitro diagnostic testing": GB/T 43279 has published the following parts: ---Part 1: Isolation of cellular RNA; ---Part 2: Isolation of genomic DNA; ---Part 3: Isolation of plasma circulating cell-free DNA: This document is equivalent to ISO :20186-2:2019 "Specification for pre-examination of venous whole blood for molecular in vitro diagnostic testing Part 2: Isolating Genomic DNA": Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents: This document is proposed by the National Medical Products Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document was drafted by: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), China National Accreditation Center for Conformity Assessment, Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protective Equipment Inspection and Research Center), Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, China Institute of Food and Drug Control, Fuwai Hospital of Chinese Academy of Medical Sciences: The main drafters of this document: Shen Zuojun, Fu Yue, Wang Ruixia, Dou Yaling, Zhang Wenxin, Zhou Zhou, and Wang Hao:

Introduction

The emergence of molecular in vitro diagnostics has enabled significant advances in medicine: However, the accuracy of molecular in vitro diagnostic results is affected by many factors: For example, irregular operations during specimen collection, transportation, storage, and processing before testing may cause the content of these molecules to and/or the integrity has changed significantly, and subsequent test analysis is affected by human factors in the pre-test process and cannot fully reflect the patient’s true condition: The actual state affects the results of diagnosis or research: Genomic DNA will be broken or degraded after blood collection: Therefore, specific measures need to be taken to ensure high-quality genomic DNA testing: test sample: This is particularly important for testing procedures requiring high molecular weight DNA (HMWDNA): The entire process from specimen collection to genomic DNA testing needs to be standardized to prevent degradation and fragmentation of genomic DNA after blood collection: Segmentation: Studies have identified important influencing factors: This paper leverages these existing efforts to compile and standardize venous whole blood genomes The steps of DNA testing, the so-called pre-test process: GB/T 43279 specifies the requirements for standardized pre-test procedures for venous whole blood molecular in vitro diagnostic tests: GB/T 43279 It is planned to consist of three parts: ---Part 1: Isolating cellular RNA: The purpose is to standardize the standardized pre-test steps for RNA testing in venous whole blood testing: Steps are taken to reduce changes and modifications in RNA profiles and ensure the validity and reliability of subsequent test results: ---Part 2: Isolating genomic DNA: The purpose is to standardize the standardized pre-test operations for DNA testing in venous whole blood testing steps to reduce the impact of DNA profile changes and modifications on subsequent testing: ---Part 3: Isolation of plasma circulating cell-free DNA: The purpose is to standardize the standards for circulating cell-free DNA testing in venous whole blood testing: Standardize the pre-test steps to reduce the impact of changes and modifications in circulating free DNA on subsequent tests: Molecular in vitro diagnostic test venous whole blood pre-test process Specification Part 2: Isolating Genomic DNA

1 Scope

This document provides operational guidelines for the pre-test phase of venous whole blood specimens used for genomic DNA testing, including specimen handling, storage storage, processing and recording: This document covers specimens collected with venous whole blood collection tubes: This document is applicable to molecular in vitro diagnostic tests performed by medical laboratories and is also applicable to laboratory customers, in vitro diagnostic developers and manufacturers: suppliers, biobanks, institutions and commercial organizations engaged in biomedical research, and regulatory agencies: This document does not cover specific methods for stabilizing circulating cell-free DNA in blood: Note: For relevant content on circulating free DNA in blood, see GB/T 43279:3-2023: This document does not address the collection, stabilization, transportation and storage of capillary blood, or the use of paper technology or other methods that produce dried blood: A specialized method of collecting and storing blood using technology: This document does not address the isolation of specific blood cells and subsequent isolation of genomic DNA: This document does not address the presence of pathogen DNA in blood:

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document: GB/T 22576:1-2018 Medical laboratory quality and capability requirements Part 1: General requirements (ISO 15189:2012, IDT)

3 Terms and definitions

The following terms and definitions apply to this document: Terminology databases for standardization maintained by ISO and IEC at the following address: ---ISO online browsing platform: http://www:iso:org/obp; 3:1 analyteanalyte The component represented by the name of the measurand: [Source: GB/T 21415-2008, 3:2, with modifications] 3:2 backflow The flow of liquid in the opposite direction to the usual or desired direction: 3:3 blood collection device bloodcollectionset A device specifically designed for venipuncture consisting of a stainless steel beveled needle and tubing (tubing) with plastic wings and connectors: ......

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