SPIDIA

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

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 Obiettivo del progetto (Objective)

'In vitro diagnostics have allowed a great deal of progress in medicine but are limited by two factors: (a) the lack of guidelines in collection, handling, stabilisation and storage of biosamples which limits the reproducibility of subsequent diagnoses, and (b) its scale is restrained to the cellular level. To address this first point, this IP, SPIDIA, built of clinicians, academics, tool and assay developers, aims to develop quality guidelines for molecular in vitro diagnostics and to standardize the pre-analytical workflow in related procedures. Regarding the second point, SPIDIA aims to develop modern pre-analytical tools for diagnostics improving the stabilisation, handling and study of free biomolecules within blood, plasma, serum, tissues and tumours. Recent discoveries have revealed that RNA, DNA or proteins, released from pathological sites, like tumour cells or Alzheimer’s disease (AD) brain lesions, into the blood or as a secondary blood based response to the disease can serve as biomarkers for early and reliable molecular diagnosis of such debilitating diseases. Further discoveries have shown that the cellular profiles of these molecules and structures in clinical samples can change during transport and storage thus making clinical assay results and pharmaceutical research unreliable or even impossible. It will therefore be a decisive prerequisite for future and current diagnostic assays to develop standards and new technologies, tools and devices that eliminate the human error in the pre-analytical steps of in vitro diagnostics. At this crucial moment in the development of molecular diagnostics, SPIDIA proposes an IP that reunites 7 private research companies (including 4 SMEs), 1 private research institute, 6 public research organisms, including universities, hospitals and biobanks, one management SME and an official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on human health.'

Introduzione (Teaser)

We need to do a better job of collecting, storing and transporting human blood, plasma, tissue and other samples before they are analysed in the laboratory. Discoveries made during the Spidia project are making sure we do just that.

Descrizione progetto (Article)

In vitro research has contributed significantly to the fields of cellular and molecular biology, and consequently to many advances in medicine. However, progress is not as fast as it could be since many of the samples are not handled correctly prior to their analysis in the laboratory.

Considerable funding from the Health research programme of FP7 has been earmarked to address this problem. Both private and public research organisations have committed to developing new standards and tools for in vitro diagnostics in the context of the Spidia project.

Over 250 laboratories have been enlisted to participate in ring trials addressing DNA and RNA in blood and plasma samples. The results are expected to drive the development of guidance documentation on key issues such as quality assurance.

In parallel, a new method of collecting and stabilising tissue samples has been created. Analysis of 3;000 samples has demonstrated superior preservation in comparison to conventional techniques such as snap freezing, where the temperature is reduced as quickly as possible, and formalin fixation. Remarkably, the new technology allows both histopathological and molecular analyses to be performed on the same sample.

Samples may travel great distances or be stored for long periods prior to their analysis. The advent of a tracking system, including both hardware and software, during Spidia will help organisations follow samples from the point of collection all the way until they are put under the microscope. A new container for storing and transporting tissue samples completes the picture.

Finally, a search has been initiated for biomarkers that reveal whether or not the quality of a sample has been impaired during processing. Both RNA and metabolic profiles show promise in this area. No stone remains unturned as new sampling techniques and stabilisation solutions are also being sought.

Fast adoption of the new technologies and standards is assured since the Spidia consortium includes a prominent pan-European standards body. The hope is that debilitating diseases, such as Alzheimer's, will be diagnosed earlier and with greater reliability.