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GB/T 43279.1-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
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GB/T 43279.1-2023
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Basic data | Standard ID | GB/T 43279.1-2023 (GB/T43279.1-2023) | | Description (Translated English) | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 22,221 | | 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 43279.1-2023: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
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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 1: Isolating cellular RNA
(ISO :20186-1:2019,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
Preface III
Introduction IV
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 cellular RNA 7
6:4 Content and quality assessment of isolated cellular RNA 8
6:5 Storage of isolated cellular RNA 8
Appendix A (informative) Effect of pre-test process steps on RNA profile of venous whole blood cells10
A:1 General information on test operations in Appendix A and Appendix B10
A:2 Effect of blood collection tube type (with/without blood cell RNA profile stabilizer) on specific blood cell RNA profile analysis10
Appendix B (informative) Effect of blood storage temperature on blood cell RNA profile 13
Reference 15
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:
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), Peking University People’s Hospital, China Food and Drug
Product Testing Institute:
The main drafters of this document: Shen Zuojun, Zhou Yali, Dai Leiying, Zhao Xiaotao, Huang Jie, Liu Liu, and Du Haiou:
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;
3:1
ambient temperature ambienttemperature
The temperature of the unconditioned ambient air:
3:2
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:
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