Let´s talk about standards….

While the first SPIDIA project had put its focus on laboratory and research activities to lay the basis for the first pre-analytical standards and EQA schemes, the current SPIDIA4P project now also focusses on their implementation in healthcare and on broadening the standards and EQA portfolio with a focus on personalized medicine.

The acitivities in the dedicated workpackages of SPIDIA4P make sure that the key requirements are covered:

Development of additional new pan-European and International Standards for pre-analytical workflows needed for Personalized Medicine

These new standard documents drafted under SPIDIA4P are again being developed within the European Technical Committee 140 “In vitro diagnostic medical devices” (CEN/TC 140) and again to identify specific workflow requirements and provide recommendations on various parameters outside and inside the research or in vitro diagnostic laboratory to optimize specimen acquisition, handling, transport, storage, and analyte isolation. This work package also targets the submission of published CEN documents to the international level (International Organization for Standardization, ISO) for the development of International Standards within the ISO Technical Committee 212 “Clinical laboratory testing and in vitro diagnostic test systems” (ISO/TC 212).

Develop External Quality Assessment Schemes for the pre-analytical phase 

This work package aims to deploy existing EQA schemes for pre-analytical processes, formerly addressed by SPIDIA, and to develop and implement new EQA schemes for pre-analytical processes to be addressed by SPIDIA4P. EQA processing schemes will be developed and provided with the biobanks and research laboratory communities. No EQA schemes for analytical (clinical diagnostic) processes will be developed in this project, since such schemes are already developed elsewhere and generally include the pre-analytical steps. However, members of this consortium will participate in these schemes in order to evaluate them and propose improvements to their providers.

Implementation and Dissemination of Standards & External Quality Assurance Schemes 

One of the main goals of SPIDIA4P is to increase the awareness about these CEN/TS and the EN ISO Standards amongst the relevant target groups (such as molecular in vitro diagnostic laboratories, biobanks and developers of diagnostic tests), achieve their acceptance and foster their implementation. This includes education about the decisive meaning of pre-analytical workflows for enabling reliable and correct analytical test results.

The involvement of major stakeholders organisations, collaboration with other consortia, infrastructures and initiatives in the respective field are crucial as well as training, state-of-the-art communication and dissemination activities that are adapted to the different target audiences.