GB/T 43279.3-2023Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (English PDF)

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:

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;

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:

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):