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2011 Call for projects in the field of viral safety for biological products
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Selected projects 2009

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Optimisation, evaluation and validation of a Protein Misfolding Cyclic Amplification (PMCA) based confirmatory screening assay to detect prions in human blood. A French and British Collaborative Study

PIs: J. Coste - EFS Pyrénées-Méditerranée, Montpellier - France, M. Jones - Scottish National Blood Transfusion Service, Edinburgh - UK

Other Investigators : J. Clewley (TSE Unit, Virus Reference Department, Center for Infections, Health Protection Agency London,UK) - R. Eglin (National Transfusion Microbiology Laboratories, NHS Blood and Transplantation, London, UK) - B. Flan and A. Bellon (LFB, Les Ulis, France) -      S. Haik and J.P. Brandel (UMRS975 (Cricm) and Centre National de Référence des ATNC, Equipe Maladie d’Alzheimer, Maladies à Prions, Hôpital de la Salpêtrière, Paris, France) - M. Head  (UK National CJD Surveillance Unit, Univ. of Edinburgh, UK) - H. Laude, V. Beringue, M. Moudjou (INRA Virologie Immunologie Moléculaire, Jouy-en-Josas, France), A. Perret-Liaudet and I.Quadrio (Service de Neurobiologie, Centre de Biologie et de Pathologie Est, Groupement Hospitalier Est des Hospices Civils de Lyon, France) - C. Prowse (Scottish National Blood Transfusion Service, Edinburgh, UK) - C. Segarra (EFS Pyrénées-Méditerranée, Montpellier, France)

It is now very likely that the infectious agent responsible for variant Creutzfeldt-Jakob disease (vCJD), a fatal disease of the brain, can be passed from person to person through blood transfusion and that this infectious agent is present in the blood of affected individuals long before clinical signs of the disease become apparent. This has led to major concerns that a pool of such infectious, symptomless individuals could exist in the general population and that some of these individuals could be routinely donating blood leading to further cases of transfusion related person to person disease transmission.

One method of preventing transfusion related disease transmission would be routinely screening all blood donations for the presence of the infectious agent. Any blood donor testing positive would be informed of the result and prevented from donating blood in the future. However, given the impact of testing positive for a fatal disease, for which there is no cure, could have on an individual’s life the need to be sure that a positive result is correct means that a second so-called “confirmatory test” will also be needed to ensure that positive results are indeed true positives.

Researchers in the UK and France have been independently working on the development of just such a confirmatory test based on the use of a method called Protein Misfolding Cyclic Amplification (PMCA) and it is proposed in this study that the researchers in the UK and France will combine their expertise and resources towards the development, evaluation and validation of a PMCA based confirmatory test to detect vCJD infectivity in blood.


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