Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
Abstract
This document specifies requirements and provides recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, transport, processing and documentation of human venous whole blood specimens intended for ccfRNA examination. Processing includes multiple steps, such as preparation of plasma and isolation of ccfRNA. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. The pre-examination process described in this document results in ccfRNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in ISO/NP, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for preexamination processes for venous whole blood - Part 1: Isolated cellular RNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Begin
2023-02-06
WI
00140159
Planned document number
DIN EN ISO 18703
Project number
06302202
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Responsible international committee
ISO/TC 212/WG 4 - Microbiology and molecular diagnostics
