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GB/T 42216.2-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue - Part 2: Isolated proteins
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue - Part 2: Isolated proteins
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GB/T 42216.2-2022
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Basic data | Standard ID | GB/T 42216.2-2022 (GB/T42216.2-2022) | | Description (Translated English) | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) 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 | 22,267 | | 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 42216.2-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) 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 for formalin fixation and
Specification for pre-examination procedures for paraffin-embedded tissue
Part 2.Isolating Proteins
(ISO.20166-2.2018, 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 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 Shipping Requirements 6
6 Inside the laboratory6
6.1 Information on Specimen Receipt6
6.2 Formalin fixation of specimens/samples6
6.3 Pathological evaluation of specimens and selection of samples 7
6.4 Fixation of frozen samples 8
6.5 Processing and paraffin embedding 8
6.6 Storage requirements 8
6.7 Separation of total protein9
6.8 Quality assessment of isolated proteins 10
6.9 Storage of total protein10
Appendix A (informative) Protein test shows changes in protein content during cold ischemia12
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"
to be drafted.
This document is part of GB/T 42216 "Specification for the pre-examination process of formalin-fixed and paraffin-embedded tissue for molecular in vitro diagnostic testing"
part 2.GB/T 42216 has issued the following parts.
--- Part 1.Isolation of RNA;
--- Part 2.Separation of proteins;
--- Part 3.Isolation of DNA.
This document is equivalent to the ISO.20166-2.2018 "Molecular in vitro diagnostic test formalin-fixed and paraffin-embedded tissue before inspection
Specification of the process Part 2.Separation of proteins.
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. Beijing Hospital, China National Accreditation Center for Conformity Assessment, Beijing Institute of Medical Device Inspection (Beijing Medical
Biological Protection Equipment Inspection and Research Center), Peking University People's Hospital, China-Japan Friendship Hospital, Cancer Hospital Affiliated to Fudan University, China Food and Drug Administration
Quality Control Institute.
The main drafters of this document. Xiao Fei, Zhou Yali, Zhao Xiaotao, Zhou Xiaoyan, Zhong Dingrong, Chen Huang, Zou Yingshu, Li Hexin, Huang Jie.
Introduction
The advent of molecular in vitro diagnostic (including molecular pathology) techniques has enabled major advances in medicine. However, molecular in vitro diagnostic results
Accuracy is affected by many factors, including irregularities in the pre-test process. Such as in the process of specimen collection, transportation, storage and processing
Irregular operations may cause significant changes in the content and/or integrity of these molecules, and subsequent inspection and analysis will be subject to pre-inspection process personnel.
Because of the influence of factors, it cannot fully reflect the real state of the patient, which will affect the results of diagnosis or research. Therefore, it is necessary to examine the specimens from
Standardize the entire pre-test process from acquisition to detection.
GB/T 42216 specifies the standardized pre-test procedures for molecular in vitro diagnostic tests of formalin-fixed and paraffin-embedded tissues
The requirements are to be composed of 4 parts.
--- Part 1.Isolation of RNA. Aims to standardize the standardization of RNA assays in formalin-fixed and paraffin-embedded tissues
The pre-test operation steps reduce the changes and modifications of RNA profiles, and ensure the validity and reliability of subsequent test results.
--- Part 2.Separation of proteins. The purpose is to standardize the standard of protein detection in formalin-fixed and paraffin-embedded tissues
The operation steps before the chemical test can reduce the influence of the change and modification of the protein spectrum on the subsequent test.
--- Part 3.Isolation of DNA. The purpose is to standardize the standardization of DNA testing of formalin-fixed and paraffin-embedded tissues
Pre-test operation steps to reduce the impact of DNA profile changes and modifications on subsequent tests.
--- Part 4.In situ detection technology. The purpose is to standardize the standardization of in situ detection of formalin-fixed and paraffin-embedded tissues
Pre-test operation steps to reduce the influence of relevant test factors on in-situ test results.
Molecular in vitro diagnostic tests for formalin fixation and
Specification for pre-examination procedures for paraffin-embedded tissue
Part 2.Isolating Proteins
1 Scope
This document presents formalin-fixed and paraffin-embedded panels for protein testing at the pre-test stage prior to molecular analysis.
Guidelines for the handling, recording, storage and collection of tissue (FFPE) specimens.
This document is applicable to molecular in vitro diagnostic tests, including laboratory self-created test items carried out by medical laboratories and molecular pathology laboratories
It also applies to laboratory customers, developers and manufacturers of in vitro diagnostics, biobanks, institutions and commercial organizations engaged in biomedical research and
Regulatory Authority.
This document does not apply to protein detection based on immunohistochemical techniques.
Note. International, national and regional regulatory requirements also apply to specific content covered in 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)
GB/T 27020-2016 Operational requirements for various inspection agencies for conformity assessment (ISO /IEC 17020.2012, IDT)
and competence)
Note. GB 19781-2005 Medical Laboratory Safety Requirements (ISO 15190.2003, IDT)
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 comes from references [28], [29], [30].
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