GB/T 43279.1-2023Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (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 1 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 :20186-1:2019 "Specification for pre-examination of venous whole blood for molecular in vitro diagnostic testing Part 1:

Isolating cellular RNA":

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:

Blood cell RNA profiles will change significantly after blood collection: Therefore, specific measures need to be taken to ensure high-quality blood specimens are used for cellular RNA testing and storage:

The entire process from specimen collection to cell RNA testing needs to be standardized: Studies have identified important influencing factors: This article this work will be used to standardize the steps in the pre-RNA assay process for venous whole blood cells:

GB/T 43279 specifies the requirements for standardized pre-test procedures for venous whole blood molecular in vitro diagnostic tests: GB/T 43279 the following sections are proposed for publication:

---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 1: Isolating cellular RNA

1 Scope

This document provides operational guidelines for the pre-test phase of venous whole blood specimens used for cellular RNA testing, 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:

suppliers, biobanks, institutions and commercial organizations engaged in biomedical research, and regulatory agencies:

This document does not cover specific methods for stabilizing blood-free circulating RNA and blood-circulating exosomal RNA:

This document does not cover the collection, stabilization, transportation and storage of capillary blood, nor does it cover the use of paper technology or other methods that can cause drying:

Blood TechnologySpecial methods for collecting and storing blood:

This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA:

This document does not cover pathogen RNA 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;

ambient temperature the temperature of the unconditioned ambient air:

analyteanalyte

The component represented by the name of the measurand:

[Source: GB/T 21415-2008, 3:2, with modifications] 3.3 backflow the flow of liquid in the opposite direction to the usual or desired direction: