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GB/T 42080.1-2022: RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
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RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
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GB/T 42080.1-2022
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Basic data | Standard ID | GB/T 42080.1-2022 (GB/T42080.1-2022) | | Description (Translated English) | RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 22,285 | | Date of Issue | 2022-12-30 | | Date of Implementation | 2023-07-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42080.1-2022: RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
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ICS 11.100.10
CCSC30
National Standards of People's Republic of China
Molecular In Vitro Diagnostic Tests
Specification for pre-examination procedures for frozen tissue
Part 1.Isolating RNA
(ISO.20184-1.2018, IDT)
Posted on 2022-12-30
2023-07-01 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 General 4
5 Lab Exterior 5
5.1 Specimen collection 5
5.2 Fresh tissue shipping requirements6
6 Inside the laboratory 7
6.1 Specimen Receiving Information 7
6.2 Specimen pathological evaluation and sample selection 7
6.3 Freezing of Specimens or Samples 7
6.4 Storage requirements 9
6.5 Isolation of RNA 9
6.6 Qualitative and quantitative assessment of isolated RNA10
6.7 Storage of isolated RNA10
Appendix A (informative) Pretest variables versus RNA obtained from frozen liver tissue samples collected during and after routine surgery
Spectrum Impact 12
A.1 Comparison of stable and unstable genes identified under ischemic conditions 12
A.2 Results-based recommendations15
Reference 16
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is part 1 of GB/T 42080 "Specification for the pre-examination process of frozen tissue for molecular in vitro diagnostic testing".
GB/T 42080 has issued the following parts.
--- Part 1.Isolation of RNA;
--- Part 2.Separation of proteins.
This document is equivalent to ISO.20184-1.2018 "Specification for the pre-examination process of frozen tissue for molecular in vitro diagnostic testing Part 1
Subsection. Isolating RNA.
The following minimal editorial changes have been made to this document.
--- Changed the number of notes in 6.3.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This document was drafted by. Guangdong Provincial People's Hospital, Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protection Equipment Inspection Institute)
Research Center), China National Institutes for Food and Drug Control.
The main drafters of this document. Yan Lixu, Dai Leiying, Qu Shoufang.
Introduction
Molecular in vitro diagnostics, including molecular pathology, have enabled major advances in medicine. With the analysis of nucleic acids in human tissues and body fluids,
New technologies for proteins and metabolites are emerging and further developments are expected. However, the molecular profiles and/or completeness of these
Significant changes may occur during collection, transportation, storage and handling, making diagnosis or research results unreliable or even impossible. this
This is because the patient's condition will not be considered in the subsequent test analysis, but the artificial map generated before the test is referred to. Therefore, it is necessary to make the subscript
The entire process from collection to detection is standardized.
GB/T 42080 "Molecular in vitro diagnostic testing of frozen tissue pre-examination process specification" stipulates the molecular in vitro diagnostic of frozen tissue
The standardization requirements for the pre-inspection operation steps of the inspection are proposed to be composed of three parts.
--- Part 1.Isolation of RNA. The purpose is to standardize the standardized pre-test operation steps for RNA testing of frozen tissues, reducing the
Minimize the change of RNA profile to ensure the validity and reliability of follow-up inspection results.
--- Part 2.Separation of proteins. The purpose is to standardize the pre-test procedures for protein testing of frozen tissues, reducing the
Minimal protein profile changes and modifications.
--- Part 3.Isolation of DNA. The purpose is to standardize the pre-test procedures for DNA testing of frozen tissues.
At present, studies have identified some important factors affecting the whole process from specimen collection to RNA detection. This document is based on this
work, has written a standardized pre-assay procedure for RNA testing of frozen tissues, and this phase of pre-assay is referred to as pre-assay
stage.
Due to the influence of various factors such as gene induction or gene downregulation, RNA profiles in frozen tissues can vary before, during, and after collection.
can undergo drastic changes. RNA species may also vary differently in different donor patient tissues. Therefore, it is necessary to take special
Measures to minimize changes in the described RNA and modifications within its tissue for subsequent examination.
Molecular In Vitro Diagnostic Tests
Specification for pre-examination procedures for frozen tissue
Part 1.Isolating RNA
1 Scope
This document provides information on the handling, recording,
Guidelines for storage and extraction.
This document is applicable to any molecular in vitro diagnostics performed by medical laboratories and molecular pathology laboratories on RNA extracted from frozen tissue
test. This document is also applicable to laboratory customers, developers and manufacturers of in vitro diagnostics, biobanks, institutions conducting biomedical research
and business organizations and regulators.
This document does not cover tissues that have been chemically stabilized before freezing.
Note. International, national or regional regulations or requirements can also apply to specific content covered by this document.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements (ISO 15189.2012,
IDT)
and competence)
3 Terms and Definitions
The terms and definitions defined in ISO 15189 and the following apply to this document.
The ISO and IEC terminology databases for standardization are maintained at the following addresses.
3.1
aliquot of sample
Assuming that sampling errors are negligible, a portion of a mass of homogeneous substance.
Note 1.This term is usually applied to liquids. Tissues are heterogeneous and so cannot be equally divided.
Note 2.This definition is derived from references [23], [24], [25].
3.2
Ambient temperature ambient temperature
The temperature of the unconditioned ambient air.
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