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BSI PD CEN/TS 17742:2022

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
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BSI PD CEN/TS 17742:2022

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma

PUBLISH DATE 2022
BSI PD CEN/TS 17742:2022

This document specifies requirements and 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, processing and documentation of venous whole blood specimens intended for ccfRNA examination.

This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of 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 laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

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
  • cellular RNA isolated from venous whole blood.
These are not described in this document but are covered in CEN/TS 17747, 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 EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination 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.

SDO BSI: British Standards Institution
Document Number CEN/TS 17742
Publication Date May 11, 2022
Language en - English
Page Count 28
Revision Level
Supercedes
Committee CH/212
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