Anyone interested in the development of in vitro diagnostics (IVD) should pay close attention to the SPIDA project, less commonly referred to as the consortium for the “Standardisation and improvement of generic pre-analytical tools and procedures for in vitro, diagnostics” based in Europe. SPIDA is a four-year, large-scale integrated project that is tackling the often overlooked problem of lack of standardization for pre-analytical handling of patient samples used for in vitro diagnostics.

IVDs have significantly advanced medicine, and new technologies for analyzing biomolecular profiles such as nucleic acids, proteins and metabolites promise to bring further progress. Yet the profiles of these molecules can drastically change as they are moved from one lab to another, one clinical trial site to another and stored in various states along the way, thus making results “unreliable or even impossible,” according to SPIDIA. We share SPIDA’s viewpoint that further progress will be limited unless guidelines for sample collection, handling, stabilization and storage of clinical samples are developed and adopted by industry. To that end, the SPIDIA consortium is working on providing guidelines, quality assurance metrics and “innovative pre-analytical tools” to advance IVDs. And it’s a serious effort. The consortium was initiated by seven public research organizations, eight research companies and an official European standards organization, and has a budget of about 13 million Euros – more than $18.5 million currently – including about 9 million Euros from the European Commission.

In the coming months, we’ll be highlighting SPIDIA’s work and in particular the progress it is making. In its spring newsletter, SPIDIA shares some details of studies it’s conducting to develop evidence-based quality guidelines for the pre-analytical phase of handling blood samples. The studies involved ring trials in which uniform samples were shipped to various European laboratories for analyzing pre-analytical variations for DNA analysis from blood and plasma samples. There were 131 applicants enrolled in the DNA Blood Ring Trial, and 67 applicants joined the DNA Plasma Ring Trial. The participants extracted DNA according to their current standard procedures. The isolated DNA samples were returned to SPIDIA laboratories (DNA Blood: 118, DNA Plasma: 62), where they were analyzed for DNA quantity and quality by spectrophotometric measurements, pulsed field gel electrophoresis, and real time PCR. They were also analyzed for the presence of interfering substances by special PCR assays. In addition, DNA integrity was determined for the plasma samples. The studies were supported by the European Federation of Clinical Chemistry and Laboratory Medicine.

SPIDA consortium members also executed a similar ring trial for the analysis of cellular RNA from blood samples. Uniform blood samples, collected in different blood collection tubes, were shipped to 102 participating laboratories. Participants isolated cellular RNA and shipped it back to SPIDIA laboratories. The received RNA samples (91) were analyzed for quality, quantity and RIN value by several RT-PCR assays and for the presence of interferences by RT-PCR assays. A report about a pilot ring trial, performed with 10 different participating laboratories in order to test the sample logistics and sample evaluation strategy, has been submitted for publication.

The project intends to use the evidence gathered during these ring trials to “elucidate problematic steps in pre-analytical procedures,” according to SPIDIA. Additionally, the consortium hopes to discover quality assurance biomarkers to serve as indicators for artificial, post-collection changes of clinical and biological samples.

SPIDIA partners will be presenting more information on the project during several upcoming events, including the 2011 BRN Symposium, the 2011 ISBER Meeting and the 2011 IFCC Symposium. The SPIDA project is now about half-way through its four-year term, and we look forward to hearing more about its progress.

Of course, we at BioCision are all about improving sample handling across all laboratory and clinical areas.