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CEN - 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

active, Most Current
Organization: CEN
Publication Date: 1 October 2019
Status: active
Page Count: 26
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes.

This document is applicable to any molecular in vitro diagnostic examination 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 are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2.

Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document.

NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9].

DNA in pathogens present in blood is not covered by this document.

[8] Thakur B.K., Zhang H., Becker A. et al. , Double-stranded DNA in exosomes: a novel biomarker in cancer detection. Cell Res. 2014, 24 pp. 766-769

[9] Peters D .L., P retorius P.J., Origin, translocation and destination of extracellular occurring DNA- A new paradigm in genetic behavior. Clin. Chim. Acta. 2011, 412 pp. 806-811

Document History

EN ISO 20186-3
October 1, 2019
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA)...

References

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