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GB/T 43279.3-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
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GB/T 43279.3-2023
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Basic data | Standard ID | GB/T 43279.3-2023 (GB/T43279.3-2023) | | Description (Translated English) | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 19,122 | | 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 43279.3-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
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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 3: Isolation of circulating cell-free DNA from plasma
fromplasma
(ISO :20186-3:2019,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 for blood specimens 7
6:3 Plasma preparation 7
6:4 Storage requirements for plasma samples 7
6:5 Isolation of ccfDNA 8
6:6 Content and quality assessment of isolated ccfDNA 9
6:7 Storage of isolated ccfDNA 9
Appendix A (informative) Effect of pre-test steps on circulating free DNA profile in venous whole blood plasma10
A:1 Changes in ccfDNA profile in blood after blood collection10
A:2 Impact of ccfDNA profile changes on the detection of epidermal growth factor receptor mutants in plasma 11
Reference 13
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 3 of GB/T 43279 "Specifications for pre-examination of venous whole blood for molecular in vitro diagnostic testing": GB/T 43279
The following sections have been published:
---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 :20186-3:2019 "Molecular in vitro diagnostic testing venous whole blood pre-test process specifications Part 3: Points
Circulating cell-free DNA from plasma:
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 Medical Device Inspection and Research Institute (Beijing Medical Biological Protective Equipment Inspection and Research Center), China Institute of Food and Drug Control, Beijing
University People's Hospital:
The main drafters of this document: Shen Zuojun, Wang Baolong, Zhou Yali, Liu Yanchun, Qu Shoufang, Zhao Xiaotao, and Zou Yingshu:
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:
After blood collection, the circulating cell-free DNA (ccfDNA) profile will undergo significant changes (such as the release of cellular genomic DNA in the blood, ccfDNA
degradation and fragmentation and changes in ccfDNA content): Therefore, specific measures need to be taken to ensure high-quality ccfDNA test samples
Book: Studies have been conducted to identify these important influencing factors [24]:
The entire process from specimen collection to ccfDNA testing needs to be standardized:
This document standardizes the steps in the pre-assay process for the preparation of circulating cell-free DNA from venous whole blood:
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 3: Isolation of circulating cell-free DNA from plasma
1 Scope
This document provides operational guidelines for the pre-test phase of venous whole blood specimens used for plasma circulating cell-free DNA (ccfDNA) testing, including
Including specimen handling, 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:
Molecular in vitro diagnostic tests conducted by vendors, biobanks, institutions and commercial organizations engaged in biomedical research, and regulatory agencies:
This document does not cover specific methods for stabilizing genomic DNA in blood: For information on genomic DNA in blood, see
ISO :20186-2:
This document does not address specific methods for DNA preservation in circulating exosomes:
NOTE: ccfDNA obtained from blood by the procedures cited in this document may contain DNA from exosomes [10-11]:
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:
Note: This connector is connected to another blood collection device, such as a blood collection tube (3:4):
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