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BSI PD CEN/TS 17747:2022

BSI PD CEN/TS 17747:2022

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins

Published By Publication Date Number of Pages
BSI 2022 30
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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for DNA, RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in isolated DNA, RNA and proteins from enriched exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-free DNA (ccfDNA) examination, both without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in EN ISO 20186 3, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 3: Isolated circulating cell free DNA from plasma and CEN/TS 17742, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Isolated circulating cell free RNA from plasma. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
5 European foreword
6 Introduction
7 1 Scope
2 Normative references
3 Terms and definitions
11 4 General Requirements
12 5 Outside the laboratory
5.1 Specimen collection
5.1.1 General
13 5.1.2 Information about the patient/specimen donor
5.1.3 Selection of the venous whole blood collection tube by the laboratory
14 5.1.4 Venous whole blood specimen collection from the patient/donor
5.2 Specimen storage and transport
5.2.1 General
15 5.2.2 Storage and transport using blood collection tubes with stabilizers
5.2.3 Storage and transport using blood collection tubes without stabilizers
6 Inside the laboratory
6.1 Specimen reception
6.2 Specimen storage after transport and reception
16 6.3 Plasma preparation
6.4 Storage requirements for plasma samples
17 6.5 Enrichment of EVs from specimen
6.5.1 General
6.5.2 Using a commercial EV enrichment system
18 6.5.3 Using the laboratory’s own EV enrichment procedure
6.5.4 Quality of enriched EVs
6.5.5 Storage of enriched EVs
6.6 Isolation of analyte of interest from EVs
6.6.1 General
19 6.6.2 Using a commercial kit for EV DNA, RNA, protein isolation intended for diagnostic use
6.6.3 Using a laboratory developed isolation procedure
20 6.7 Quantity and quality assessment of isolated analyte of interest
6.7.1 General
21 6.7.2 Quantity assessment of EV DNA and RNA
6.7.3 Quality assessment of DNA and RNA
6.7.4 Quantity and quality assessment of EV proteins
22 6.8 Storage of isolated analyte of interest
6.8.1 General
6.8.2 Storage of DNA
23 6.8.3 Storage of RNA
24 6.8.4 Storage of EV protein
25 Annex A (informative) Example of a typical protocol for plasma preparation for EV enrichment from unstabilized blood
26 Annex B (informative) Overview of different enrichment procedures
28 Bibliography

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BSI PD CEN/TS 17747:2022
$142.49