ISO 20184-2:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations 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 Fresh tissue transport requirements
5.2.1 General
5.2.2 Preparations for the transport
5.2.3 During transport
6 Inside the laboratory
6.1 Information about the reception of the specimen
6.2 Evaluation of the pathology of the specimen and selection of the sample(s)
6.3 Freezing of the specimen or sample(s)
6.4 Storage requirements
6.5 Isolation of total protein
6.5.1 General
6.5.2 Using commercial kits
6.5.3 Using the laboratories own protocols
6.6 Quantity and quality assessment of isolated proteins
6.7 Storage of isolated total protein
Annex A (informative) Quantitative protein examination demonstrates changes of protein amounts during cold ischemia
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 Fresh tissue transport requirements
5.2.1 General
5.2.2 Preparations for the transport
5.2.3 During transport
6 Inside the laboratory
6.1 Information about the reception of the specimen
6.2 Evaluation of the pathology of the specimen and selection of the sample(s)
6.3 Freezing of the specimen or sample(s)
6.4 Storage requirements
6.5 Isolation of total protein
6.5.1 General
6.5.2 Using commercial kits
6.5.3 Using the laboratories own protocols
6.6 Quantity and quality assessment of isolated proteins
6.7 Storage of isolated total protein
Annex A (informative) Quantitative protein examination demonstrates changes of protein amounts during cold ischemia
Bibliography