Standardisation
And Improvement

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

The 2022 edition of the SPIDIA4P Newsletter is published!

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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+++ Don´t miss the BBMRI.QM Academy: Live Webinar "Validation and verification of processing methods and biobanking" on June 1, 2023 - registration and more information in section Event & Trainings - External events +++
  1. Spidia

Event date: June 1, 2023

BBMRI.QM Academy: Live Webinar
"Validation and verification of processing methods and biobanking"
June 1, 2023
Speaker: Dr. Fay Betsou
Moderator: Andrea Wutte, MSc

Register now:

NEWS

Two new publication by researchers from SPIDIA4P partner Med Uni Graz, who also have contributed to the development of pre-analytical quality standards for FFPE tissue and isolated microbiome DNA for DNA analyses!

Read it:

 ...

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

 

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”.

 

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. 

Continue Reading

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