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XMRV) and Its Implications for Blood Donation TECHNICAL REPORT Risk assessment on xenotropic murine leukemia virus-related virus (XMRV) and its implications for blood donation www.ecdc.europa.eu ECDC TECHNICAL REPORT Risk assessment on xenotropic murine leukemia virus-related virus (XMRV) and its implications for blood donation Ad hoc expert panel on XMRV implications for blood donation ECDC internal review group: Tobias Bergroth, Mika Salminen, Ana-Belen Escriva. External experts: No external experts were involved in the production of this risk assessment. The content and conclusions of this risk assessment were valid when sent to the European Commission on 22 July 2011. Suggested citation: European Centre for Disease Prevention and Control. Title: Risk assessment on xenotropic murine leukemia virus-related virus (XMRV) and its implications for blood donation. Stockholm: ECDC; 2011. Stockholm, December 2011 ISBN 978-92-9193-325-9 doi 10.2900/17643 © European Centre for Disease Prevention and Control, 2011 Reproduction is authorised, provided the source is acknowledged. TECHNICAL REPORT Risk assessment on XMRV and its implications for blood donation Contents Executive summary ........................................................................................................................................1 Introduction .............................................................................................................................................1 Methodology ............................................................................................................................................1 Results and conclusions .............................................................................................................................1 Request from the European Commission ..........................................................................................................2 Methods ........................................................................................................................................................3 Legal authority .........................................................................................................................................3 Evidence-based public health .....................................................................................................................3 Evidence-based methodologies ..................................................................................................................3 Questions from the Commission .................................................................................................................3 Search strategies ......................................................................................................................................3 Assessment of the evidence .......................................................................................................................4 References: Background and methods ........................................................................................................4 Current EU requirements for testing and donor deferral .....................................................................................4 Background ...................................................................................................................................................4 Chronic fatigue syndrome ..........................................................................................................................4 Xenotropic murine leukemia virus-related virus ............................................................................................5 Scientific studies ............................................................................................................................................5 XMRV and MLV in CFS patients ..................................................................................................................5 XRMV in other non-CFS populations ............................................................................................................6 Contamination ..........................................................................................................................................7 Animal models ..........................................................................................................................................7 Ongoing studies ........................................................................................................................................7 Editorial expression of concern ...................................................................................................................8 Koch's postulates ......................................................................................................................................9 The Bradford Hill criteria.......................................................................................................................... 10 United States.......................................................................................................................................... 11 Canada .................................................................................................................................................. 12 New Zealand .......................................................................................................................................... 12 Australia ................................................................................................................................................ 12 United Kingdom ...................................................................................................................................... 12 Summary of findings .................................................................................................................................... 12 Conclusions ............................................................................................................................................ 13 Considerations ............................................................................................................................................. 14 Donor screening ..................................................................................................................................... 14 Donor deferral ........................................................................................................................................ 14 References .................................................................................................................................................. 15 Annex 1. Search strategy .............................................................................................................................. 19 Annex 2. Evidence tables .............................................................................................................................. 21 iii Risk assessment on XMRV and its implications for blood donation TECHNICAL REPORT Abbreviations AABB former American Association of Blood Banks CD4 Cluster of differentiation 4 CDC Centers for Disease Control and Prevention CE Conformité Européenne/European Conformity. CFS Chronic fatigue syndrome CSF Cerebral spinal fluid DG SANCO European Commission's Directorate General for Health and Consumers DMSO Dimethyl sulfoxide DNA Deoxyribonucleic acid ECDC European Centre for Disease Prevention and Control EDTA Ethylenediaminetetraacetic acid EIA Enzyme immunoassay ELISA Enzyme-linked immunosorbent assay env Envelope FDA Food and Drug Administration FISH Fluorescence in situ hybridisation gag Group-specific antigen HBV Hepatitis B virus HCV Hepatitis C virus HIV Human immunodeficiency virus HTLV Human T-lymphotropic virus IAP Intracisternal A-type particle IFA Indirect fluorescent antibody IFC Immunofluorescent cell ME Myalgic encephalomyelitis MLV Murine leukemia virus NIAID National Institute of Allergy and Infectious Diseases NZB New Zealand black retrovirus PBMCs Peripheral blood mononuclear cells PCR Polymerase chain reaction pol Polymerase RNase L Ribonuclease L RT-PCR Reverse transcriptase polymerase chain reaction SFFV Spleen focus-forming virus SV-40 Simian virus 40 VIPDx Viral Immune Pathology Diagnostics WB Western blot WPI Whittemore Peterson Institute XMRV Xenotropic murine leukemia virus-related virus iv TECHNICAL REPORT Risk assessment on XMRV and its implications for blood donation Executive summary Introduction ECDC plays an important role in providing its stakeholders with scientific advice when requested. On 23 September 2010 ECDC received such a request from the European Commission’s DG SANCO (Directorate C – Public Health and Risk Assessment). ECDC was asked: • to assess the epidemiological profile of XMRV (Xenotropic murine leukemia virus-related virus); • to assess the scientific evidence of the link between chronic fatigue syndrome (CFS) and the presence of XMRV in the blood and transmission of XMRV via blood donation; • to advise the Commission on the possible value of introducing deferral criteria and/or testing requirements in the EU. Methodology In accordance with its internal procedures for providing scientific advice, ECDC addressed the question by setting up an ad hoc group of internal experts. External experts were not consulted as ECDC had personnel in house with the relevant retroviral specialist expertise. Due to the novelty of the field it was
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