Standardisation
And Improvement

of generic pre-analytical tools and
procedures for in-vitro diagnostics

NEW SPIDIA4P Newsletter 2023/2024 OUT NOW!

Read it to get the latest insights about the new ISO and CEN standard documents,
publications, conferences, trainings and many more!

NEW CEN/TS

and ISO Standards published!

SPIDIA4P at the EU Parliament!

Take a look at this very successful event!

Co-Working

Get more information about Collaborations,
Co-working and Networking with other initiatives

Background

Quality of samples matters!
Find out, why!

PROJECT PARTNERS

Learn more about the project partners that build this consortium.

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++++ WATCH the new educational video about the importance of cfDNA stabilization in urine, provided by SPIDIA4P project partner PreAnalytiX in the NEWS & Media section!!!++++
  1. Spidia

EVENTS

Review: Europe Biobank Week 2024

More than 600 delegates from various countries and over 40 exhibitors participated at the Europe Biobank Week 2024 in the Vienna Hofburg from 14-17 May 2024. This year’s motto was “Strengthening Biobanks and Biorepositories: Collaborative approaches for a sustainable future”. Get an event review, abstracts and a new poster from SPIDIA4P consortium members!

 

NEWS

Our work and mission continues! Former SPIDIA4P members regularly participate in ISO/ TC Working Groups globally to ensure that the developed and published CEN/TS standards progress into global ISO standards.

Take a look!

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Partners

spidia4p-Partners

Learn more about the highly experienced European project partners that collaborate to reach the goals of SPIDIA4P

Background

SPIDIA4P

Quality of samples matters – find out, why!

OUR MISSION CONTINUES...

 

SPIDIA4P enables even better diagnosis and medical research for personalized medicine than we already know today
 

Sample quality is key - standards reduce variations in the samples by preventing divergent methods or circumstances affecting the final results.

This promises more reliable and reproducible results, enabling the even better and more efficient diagnosis and medical research for precision medicine than we already know today.

Publicly funded from 2017 to 2021, the EU Horizon 2020 project SPIDIA4P aimed to drive the standardisation of pre-analytical workflows applied to personalised medicine by developing and implementing a portfolio of 22 pan-European CEN and international ISO standard documents, as well as external quality assessment schemes (EQAs), ultimately improving worldwide healthcare.
The standards also support the implementation of the new EU In vitro Diagnostic Regulation (IVDR).

Despite its EU funding end, SPIDIA4P’s journey is continuing – not only via other ongoing EU grant projects working on diagnostic workflow standardization, but also by transitioning initial pre-analytical CEN/TS documents to international ISO standards via the ISO/Technical Committee 212 for “Clinical laboratory testing and in vitro diagnostic test systems”.

Go to our Co-Working site to find out, in which consortia and cooperations SPIDIA4P project members are driving the standardisation:

CO-WORKING

 

Consortium

The SPIDIA4P consortium was built by 19 highly experienced partners in international standardisation for in vitro diagnostics, coming from private industry including SMEs, public institutions and from one official European Standards Organisation, CEN, represented by DIN. The consortium involved partners from DE,UK, CH, SE, IT, AT, LU, FR, NE, SP. 

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Because analytical test results are depending on the quality of the tested sample, it is of utmost importance that the handling and documentation of the primary sample during the pre-analytic phase is done in a standardized manner. For this to be facilitated and widely spread, in order to enable the urgently needed improvement in the pre-analytic field, standardization is key.

Dr. Uwe Oelmueller, SPIDIA and SPIDIA4P Coordinator

Technical Specifications and ISO Standards

 

Technical Specifications (CEN/TS) are developed within the European standard organizations (CEN) Technical Committee CEN/ TC 140 "In vitro diagnostic medical devices", and further introduced to the international organization of standardizations (ISO) technical committee ISO/ TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" with EN ISO standards with support by SPIDIA and SPIDIA4P.

Click here to get an overview of the CEN/ TS and ISO standards!

OUR PARTNERS