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.<\/p>\n
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| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 4 General Requirements <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 5 Outside the laboratory 5.1 Specimen collection 5.1.1 General <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5.1.2 Information about the patient\/specimen donor 5.1.3 Selection of the venous whole blood collection tube by the laboratory <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5.1.4 Venous whole blood specimen collection from the patient\/donor 5.2 Specimen storage and transport 5.2.1 General <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 6.3 Plasma preparation 6.4 Storage requirements for plasma samples <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6.5 Enrichment of EVs from specimen 6.5.1 General 6.5.2 Using a commercial EV enrichment system <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6.5.3 Using the laboratory\u2019s 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6.7 Quantity and quality assessment of isolated analyte of interest 6.7.1 General <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6.8 Storage of isolated analyte of interest 6.8.1 General 6.8.2 Storage of DNA <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6.8.3 Storage of RNA <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.8.4 Storage of EV protein <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex A (informative) Example of a typical protocol for plasma preparation for EV enrichment from unstabilized blood <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Annex B (informative) Overview of different enrichment procedures <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins<\/b><\/p>\n |