In Western Europe, blood and organ safety is not guaranteed for several reasons: 1) Emerging novel infectious agents and mutating known viruses remain a permanent threat; 2) Currently, it takes many years to assess the clinical relevance of new/mutated pathogens and to take appropriate measures; 3) Appropriate and cost-effective screening procedures (e.g. not all blood-borne viruses are screened for, viruses mutate and may escape detection) are not fully available; 4) 30-40% of recipients are immunodeficient and at considerably higher risk of infection and of pathogenic consequences than those immunocompetent. However, this higher level of risk has not been addressed adequately and specific safety measures to reduce it remain to be defined.BOTIA aims to improve safety of blood transfusion/ organ transplantation by: 1) The creation of an infrastructure consisting of an EU-wide sample repository of paired donor and recipient samples that will enable fast assessment of emerging blood borne agents such that appropriate measures can be taken without delay. This repository will also be a valuable tool for studying new safety aspects of already known viruses in relation to immunodeficiency and for carrying out retrospective studies once new viruses are identified after completing the BOTIA project; 2) The identification of novel/mutated blood and organ borne viruses by applying a PCR-based assay, enabling detection of viral DNA or RNA without a priori knowledge about the agent genome; 3) The improvement of donor screening in a number of ways: a) identifying limitations in current screening procedures; b) developing more cost-effective and safer screening procedures for EU countries (multiplex screening assays), c) developing inexpensive and simple test procedures for newly discovered viruses for less developed countries. On the basis of results, BOTIA will produce a range of recommendations to sanitary authorities.
Keywords:
Blood transfusion, organ transplantation, safety, emerging viruses, blood sample repository, screening tests, research infrastructure, recommendations, sanitary authorities
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