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GB/T 42080.2-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
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GB/T 42080.2-2022
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Basic data | Standard ID | GB/T 42080.2-2022 (GB/T42080.2-2022) | | Description (Translated English) | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 18,165 | | 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 42080.2-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
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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 2.Isolating Proteins
(ISO.20184-2.2018, 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 I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 General 4
5 Lab Exterior 4
5.1 Specimen collection 4
5.2 Fresh tissue shipping requirements5
6 Inside the laboratory6
6.1 Specimen Receiving Information 6
6.2 Specimen pathological evaluation and sample selection 6
6.3 Freezing of Specimens or Samples 7
6.4 Storage requirements 8
6.5 Separation of total protein 8
6.6 Qualitative and quantitative evaluation of isolated proteins9
6.7 Storage of isolated proteins9
Appendix A (informative) Quantitative detection of protein shows the change of protein content during cold ischemia10
A.1 Overview 10
A.2 Example 10
Reference 14
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 2 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.20184-2.2018 "Specification for the pre-examination process of frozen tissue for molecular in vitro diagnostic testing Part 2.
Protein Isolation".
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, Zou Yingshu, Huang Jie.
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. because
Therefore, the whole process from specimen collection to protein detection needs to be standardized. Studies have been carried out to identify important influencing factors
white. This document draws on these efforts to codify and standardize the steps for protein inspection of frozen tissues during the pre-examination process.
Protein profiles and protein profiles in tissues before, during (e.g., due to warm ischemia), and after (e.g., due to cold ischemia) tissue collection
Mass-protein interactions can change drastically. These changes are caused by gene induction, gene downregulation, protein degradation, etc. different
The amount of protein species may vary in donor/patient tissue. Gene expression can be affected by specific treatments or interventions (surgery, live
test) or drugs used for anesthesia or even to treat concomitant diseases, and the influence of different environmental conditions after the tissue is removed from the body.
Therefore, it is necessary to take special measures to minimize changes and modifications of protein profiles within said tissues for subsequent examination.
GB/T 42080 "Molecular In Vitro Diagnostic Tests Specifications for Pre-examination Procedures for Frozen Tissues" specifies the molecular in vitro diagnostic tests for frozen tissues
The standardization requirements of pre-inspection operation steps 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 detection of frozen tissues, reduce
Changes in the RNA profile ensure the validity and reliability of follow-up inspection results.
--- Part 2.Separation of proteins. The purpose is to standardize the pre-test operation steps of protein detection in frozen tissues, reduce
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.
Molecular In Vitro Diagnostic Tests
Specification for pre-examination procedures for frozen tissue
Part 2.Isolating Proteins
1 Scope
This document provides guidelines for the handling, documentation, storage of frozen tissue specimens for protein testing in the pre-test phase prior to molecular analysis.
A guide to archiving and retrieving materials.
This document is applicable to any molecular in vitro diagnostics performed by medical laboratories and molecular pathology laboratories on proteins extracted from frozen tissues
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.
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)
3 Terms and Definitions
The following terms and definitions defined in GB/T 22576.1-2018 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 term is derived from references [17], [18], [19].
3.2
Ambient temperature ambient temperature
The temperature of the unconditioned ambient air.
3.3
Analyte
The component represented by the name of the measurand.
[Source. GB/T 21415-2008, 3.2]
3.4
Measures the accuracy, precision, and sensitivity of an assay for the analyte being measured.
Note. It can also be applied to other detection performance characteristics, such as robustness, repeatability, etc.
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