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CEN/TS 17305:2019, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
EN ISO 20166-1:2018, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 1: Isolated RNA (ISO 20166-1:2018)
EN ISO 20166-2:2018, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 2: Isolated proteins (ISO 20166-2:2018)
EN ISO 20166-3:2019, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 3: Isolated DNA (ISO 20166-3:2018)
EN ISO 20184-1:2018, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 1: Isolated RNA (ISO 20184-1:2018)
EN ISO 20184-2:2018, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 2: Isolated proteins (ISO 20184-2:2018)
EN ISO 20186-1:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
EN ISO 20186-2:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-1:2019)
CEN/TS 16826-3:2018, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA
CEN/TS 16945, metabolomics in urine, serum and plasma

STANDARDIZATION IS KEY IN THE PRE-ANALYTICAL FIELD

Progress in personalised medicine is limited by missing pan-European and international standard documents and insufficient guidelines for pre-analytical workflows. This situation does currently not sufficiently prevent using compromised patients’ samples with post collection changes in cellular and extracellular biomolecules’ profiles, thus often making diagnostic test results unreliable or even impossible. To tackle this, SPIDA4P plans to initiate, develop and implement a comprehensive portfolio of an additional 14 pan-European pre-analytical CEN/TS and ISO/IS documents, addressing the important pre-analytical workflows applied to personalized medicine.

First studies had been already undertaken by the first SPIDIA programme to determine the important influencing pre-analytical factors in regard to blood, plasma, urine and tissue samples. The SPIDIA research and other studies‘ results were provided to the CEN/Technical Commitee 140 for “In vitro medical devices” (CEN/TC 140) as the basis for developing the first CEN Technical Specifications (CEN/TS) for pre-analytical workflows. Most of them meanwhile further progressed to ISO standards (see above)

12 PLANNED OR MEANWHILE EXECUTED NEW PAN-EUROPEAN PRE-ANALYTICAL CEN TECHNICAL SPECIFICATIONS

•  3 new pre-analytical CEN/technical specification documents for in venous whole blood circulating tumour and organ cells (DNA, RNA, staining procedures)

•  1 for venous whole blood exosomes

•  1 for venous whole blood cell free circulating RNA

•  1 for saliva (DNA) - published

•  1 for frozen tissues (DNA) - published

•  1 for urine and other body fluids (cell-free DNA)

•  3 for fine needle aspirates (RNA, DNA, Proteins)

•  1 for human specimen microbiome (DNA)

2 PLANNED NEW INTERNATIONAL PRE-ANALYTICAL ISO STANDARDS

•  1 for FFPE tissues (in-situ staining procedures)

•  1 for metabolomics (urine, blood plasma, blood serum)

13 PLANNED NEW  EXTERNAL QUALITY ASSURANCE  SCHEMES

•  Venous Whole Blood: Genomic DNA and cellular RNA, viable PBMC, Cell Free Circulating DNA (ccfDNA), Cell Free Circulating RNA (ccfRNA), Circulating Tumour Cells (CTCs)

•  FFPE tissue: Genomic DNA, RNA, protein

•  Frozen tissue: Genomic DNA, RNA, protein

•  Saliva: DNA

•  Stool: DNA 

An overview of the CEN/TS can be found here:

www.standards.cen.eu

The CEN/TS documents are available through the National Standardization Bodies of individual members of the European Committee for Standardization, CEN (www.cen.eu). A list of CEN members is provided here:

CEN members

The further development to ISO Standards by the ISO/TC 212 with a worldwide impact is currently the next big step towards the improvement of healthcare systems.

International Standard documents are available through the International Organization for Standardization (ISO) (www.iso.org) as well as through the National Standardization Bodies of individual members. A list of ISO members is provided here:

www.ISO.ORG