In vitro diagnostics promises to provide insight into biological and pathological processes predicting disease development or indicating individualized courses of therapy. A prerequisite for the further improvement of the diagnosis and prognosis of diseases is the development of systems and procedures involved in all stages of the process from specimen collection throughout the analysis.
A critical point in the process is the treatment of the sample material before the analysis itself takes place – the so-called pre-analytical phase. If the sample is not stabilised as soon as possible after its collection from the human body, the following analysis loses reliability and reproducibility because the biological or chemical structure of the sample material will have changed between the collection and the analysis and will not reflect the real situation in the patient's body anymore. This could influence the diagnosis or the choice of a therapy to the detriment of the patient.
Therefore, standardization of the entire process from sample collection to analysis, with integrated sample collection devices, is needed.
This is the aim of SPIDIA, a project under the European Union's Seventh Framework Programme for Research and Development (FP7), which aims at setting new standards for in vitro diagnostics, in particular for the pre-analytical phase.
The project consortium is composed of 15 members from 13 European countries. The consortium embraces public and private companies and institutes, including large companies and universities, as well as a managing partner.
CEN is participating in SPIDIA as a full partner. Work under this project will be carried out in close coordination with CEN/TC 140 'In vitro diagnostic medical devices', who is, for the time being, not covering the pre-analytical phase of the in vitro diagnostic analysis process.
The project will last for a period of four years (1 October 2008 to 30 September 2012).
Go to SPIDIA Website.