ISO 20166-1:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
5.1 Specimen collection
5.1.1 General
5.1.2 Information about the specimen donor/patient
5.1.3 Information about the specimen
5.1.4 Specimen processing
5.2 Transport requirements
6 Inside the laboratory
6.1 Information about the reception of the specimen
6.2 Formalin fixation of the specimen or sample(s)
6.3 Evaluation of the pathology of the specimen and selection of the sample(s)
6.4 Post-fixation of frozen samples
6.5 Decalcification
6.6 Processing and paraffin embedding
6.7 Storage requirements
6.8 Isolation of RNA
6.8.1 General
6.8.2 General information for RNA isolation procedures
6.8.3 Using commercial kits
6.8.4 Using the laboratories’ own protocols
6.9 Quantity and quality assessment of isolated RNA
6.10 Storage of isolated RNA
6.10.1 General
6.10.2 Using commercially available kits for RNA isolation
6.10.3 Using the laboratory's own protocols for RNA isolation
Annex A (informative) Quality control of RNA extracted from formalin-fixed and paraffin-embedded tissue samples: implications for RT-qPCR based examinations
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
5.1 Specimen collection
5.1.1 General
5.1.2 Information about the specimen donor/patient
5.1.3 Information about the specimen
5.1.4 Specimen processing
5.2 Transport requirements
6 Inside the laboratory
6.1 Information about the reception of the specimen
6.2 Formalin fixation of the specimen or sample(s)
6.3 Evaluation of the pathology of the specimen and selection of the sample(s)
6.4 Post-fixation of frozen samples
6.5 Decalcification
6.6 Processing and paraffin embedding
6.7 Storage requirements
6.8 Isolation of RNA
6.8.1 General
6.8.2 General information for RNA isolation procedures
6.8.3 Using commercial kits
6.8.4 Using the laboratories’ own protocols
6.9 Quantity and quality assessment of isolated RNA
6.10 Storage of isolated RNA
6.10.1 General
6.10.2 Using commercially available kits for RNA isolation
6.10.3 Using the laboratory's own protocols for RNA isolation
Annex A (informative) Quality control of RNA extracted from formalin-fixed and paraffin-embedded tissue samples: implications for RT-qPCR based examinations
Bibliography