GB/T 42216.3-2022 English PDF

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GB/T 42216.3-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 42216.3-2022	334	Add to Cart	4 days	Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA	Valid

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Basic data

Standard ID: GB/T 42216.3-2022 (GB/T42216.3-2022)
Description (Translated English): Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.100.10
Word Count Estimation: 18,170
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 42216.3-2022: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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 3.Isolating DNA Part 3.IsolatedDNA (ISO.20166-3.2018, 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 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 7 6.5 Decalcification 8 6.6 Processing and paraffin embedding 8 6.7 Storage requirements 8 6.8 Isolation of DNA 8 6.9 Quantity and quality assessment of isolated DNA10 6.10 Storage of DNA 10 Appendix A (informative) Effect of storage temperature on DNA integrity of FFPE tissue blocks11 Reference 13

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 of GB/T 42216 "Specification for the pre-examination process of formalin-fixed and paraffin-embedded tissue for molecular in vitro diagnostic testing" Part 3.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.20166-3.2018 "Molecular in vitro diagnostic test formalin-fixed and paraffin-embedded tissue before inspection Specification of the procedure Part 3.Isolation of DNA. 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, Zhong Dingrong, Zhou Yali, Zhou Xiaoyan, Zhao Xiaotao, Chen Huang, Du Haiou, Li Hexin, Tian Yabin.

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 RNA testing of 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. Aims to standardize the standardization of protein assays in formalin-fixed and paraffin-embedded tissues The operation steps before chemical testing can reduce the impact of protein profile changes and modifications on subsequent testing. --- Part 3.Isolation of DNA. Aims to standardize 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. Aims to standardize in situ testing 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 3.Isolating DNA

1 Scope

This document presents formalin-fixed and paraffin-embedded panels for DNA testing at the pretest 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 Also applicable to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations engaged in biomedical research and regulators. 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 [26], [27], [28]. 3.2 Ambient temperature ambient temperature The temperature of the unconditioned ambient air. ......

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