Aside from supplying traditional biobanking services to EU consortia, IBBL has increasingly been
strengthening its position as the EU provider of external quality assessment (EQA) schemes through its participation in several EU-funded projects. In 2017, another opportunity to share its expertise in this area saw its official kick off – the project SPIDIA4P (Standardisation of generic Preanalytical Procedures for In vitro DIAgnostics for Personalised Medicine), aiming to promote the standardisation of biobanking operations.
“Standardising procedures is crucial if we want to reduce the incidence of irreproducible pre-clinical and clinical research results and diagnostic mistakes.”
PharmD, PhD, Project Manager
A double priority
IBBL is one of the few biobanks that carries out biospecimen research and develops quality control assays to ensure that biological samples are suitable for their intended downstream purposes. As such, one of its main matters of concern is the contribution to the standardisation of biobanking practices through the development of global technical standards that will guarantee reproducible results (see the success story ‘A pioneer in quality and standardisation’). This also reflects another one of IBBL’s priorities, namely its inclination towards the international dimension and willingness to put its expertise at the service of the European scientific community. Indeed, IBBL is striving to consolidate its EU-wide contributions by offering international Proficiency Testing (PT) progammes supporting the various biobanking technical standards. This dual priority culminated in an important achievement.
A natural match
The year 2017 saw the concretisation of an ideal opportunity, in line with IBBL’s dedication to standardisation and its European outreach. In January 2017, the SPIDIA4P project kicked off, with IBBL counting among its consortium partners. SPIDIA4P (Standardisation of generic Preanalytical Procedures for In vitro DIAgnostics for Personalised Medicine) is a 48-month support and coordination action funded by the European Commission under the Horizon 2020 programme. It seeks to initiate, develop and implement a comprehensive portfolio of 20 pan-European CEN* Technical Specifications (CEN/ TS) and ISO International Standards (ISO/IS) documents, as well as corresponding external quality assessment schemes (EQAs). These TS – normative documents in areas where the actual state of the art is not yet sufficiently established for a European Standard – cover the pre-analytical workflows applied to personalised medicine, from documentation of patient information to sample collection, transport, processing and storage. They will also be applicable to research such as biomarker discovery and validation, as well as to biobanks, thus being a topic of particular interest and relevance for IBBL. SPIDIA4P is the follow-up of the earlier SPIDIA project, which set the foundation for the development and introduction of the first CEN/TS for pre-analytical workflows in Europe and for their progress to ISO standards. “Standardising procedures is crucial if we want to reduce the incidence of irreproducible pre-clinical and clinical research results and diagnostic mistakes”, comments Amélie Gaignaux, Project Manager at IBBL. “Our participation in this consortium of highly experienced partners could not be a better fit for us. The standardisation of biobanking practices at the European and international level is one of our top priorities”.
Quality pre-analytical workflows
As the leader of Work Package 2 (WP2), IBBL’s role in SPIDIA4P revolves around the development and implementation of external quality assessment (EQA) schemes that will accompany the pre-analytical procedures. The EQAs will assess the efficiency of sample preparation methods in terms of the quality of the resulting samples, to be used for downstream diagnostic or research purposes. Specifically, IBBL’s long-standing expertise as the sole provider of Proficiency Testing (PT) programmes for biobanks, entirely dedicated to biospecimens, proves to be an asset for the activities of WP2. IBBL’s PT programme – endorsed by the International Society for Biological and Environmental Repositories (ISBER) – acts as an EQA research tool for a variety of institutions handling biological samples (laboratories, biorepositories, etc.), allowing them to validate their routine processing and analytical methods, compare their performance to that of others, comply with normative requirements and strengthen their credibility and visibility. Notably, IBBL has developed both a series of ‘processing schemes’, which allow the verification and benchmarking of the performance of biospecimen processing methods, as well as ‘analytical schemes’, focusing on the accuracy of the measurements made to qualify the specimens.
Given its proven effectiveness, IBBL’s existing PT programme will provide the basis for the development and deployment of new PT schemes for pre-analytical processing methods. Some of IBBL’s existing schemes that will be enriched by the consortium include DNA and RNA isolation from whole blood samples, DNA extractions from saliva and stool, as well as DNA and RNA isolation from FFPE (formalin fixed and paraffin embedded) samples. Proficiency Testing schemes on liquid biopsies previously developed by IBBL under the project CANCER-ID – namely isolation of circulating cell-free DNA, circulating cell-free RNA and circulating tumour cells from whole blood – will be used ‘as is’ by SPIDIA4P. “We are honoured that the efforts we put in conceiving, deploying and refining our PT schemes have been recognised at the EU level and that our work will be able to feed the activities of SPIDIA4P”, states Olga Kofanova, Biospecimen Quality Team Leader at IBBL.
*CEN : European Committee for Standardisation
“We are honoured that the efforts we put in conceiving, deploying and refining our PT schemes have been recognised at the EU level”
PhD, Biospecimen Quality Team LeaderBACK