Pathogens in the Blood Supply
Tuesday, March 29, 2011
According to America's Blood Centers, approximately 14 million units of blood are transfused in the United States every year. Current screening protocols routinely test for several pathogens, including the Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency viruses, Types 1 and 2, Human T-Lymphotropic virus Types 1 and 2 and syphilis. Recent headlines indicate that the blood supply may contain other organisms, such as Xenotropic Murine Leukemia Virus Related Virus (XMRV), that are not currently being identified in these routine screens. This symposium will diagnose the current problems, reveal recent advances in the testing and screening of the blood supply, and will explore future directions.
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Welcome and Introduction
|1:10 PM - 2:00 PM
The Current State of Blood Banking
Transfusion Transmitted Infectious Diseases: Strategies to Prevent Transmission
Infectious Disease Risks for Transfusion Safety; Past, Present and Future
Strategies for Detection of XMRV in Blood
What's Next? Emerging Challenges to a Safe Blood Supply
Protecting the Blood Supply from Emerging Pathogens
Lorrence H. Green, PhD
Jennifer Henry, PhD
The New York Academy of Sciences
Debra Kessler RN, MS
New York Blood Center
Ms. Kessler is a former psychiatric nurse with a Masters Degree in Health Care Administration. She began work at the New York Blood Center in 1987 and is now the Director of Special Donor and Community Health Services. She is responsible for donor notification and counseling regarding infectious disease testing and advises hospital transfusion services about transfusion transmission of infectious diseases. Among other American Association of Blood Banks committees she serves on the Transfusion Transmitted Diseases Committee. She has also been the Principle Investigator at NY Blood Center for many studies, been an author on a number of publications and made numerous professional presentations.
Sanjai Kumar, PhD
Food and Drug Administration
Sanjai Kumar, Ph.D. is Chief, Laboratory of Emerging Pathogens, Division of Emerging and Transfusion transmitted Diseases, Center for Biologics Evaluation and Research at FDA. His expertise includes diagnostics, and molecular immunology and pathogenesis of malaria and babesiosis, and blood safety from infectious agents. Dr. Kumar joined FDA in 2002 as a Senior Investigator to initiate a research/regulatory program on malaria diagnostics, immunology and pathogenesis. His prior experiences included ten years at National Institute of Allergy and Infectious Diseases, five years as Senior Scientist at the US Navy Malaria Program and eight years as Adjunct Faculty, School of Public Health, Johns Hopkins University. Dr. Kumar serves on several international advisory and grant panels including the World Health Organization and National Institutes of Health. Since 2003, Dr. Kumar has served as Associate Editor, Infection and Immunity.
W. Ian Lipkin, MD
W. Ian Lipkin, MD, is the John Snow Professor of Epidemiology, Professor of Neurology and Pathology, and Director of the Center for Infection and Immunity, the Northeast Biodefense Center, and the WHO Collaborating Centre on Diagnostics, Surveillance and Immunotherapeutics for Emerging Infectious and Zoonotic Diseases. A graduate of Sarah Lawrence College, he obtained his MD at Rush Medical College, Medicine Residency at the University of Washington, Neurology Residency at the UCSF, and Fellowship in Neurovirology and Neuroscience at The Scripps Research Institute. His contributions include the first use of purely molecular methods to identify an infectious agent; implication of West Nile virus as the cause of the encephalitis in North America in 1999; invention of MassTag PCR and the first panmicrobial microarray; first use of deep sequencing in pathogen discovery; discovery of more than 300 viruses including rhinovirus C, Dandenong, and LuJo; and establishment of the largest prospective birth cohort focused on pathogenesis and biomarker discovery. He served in Beijing as an intermediary between the WHO and the Chinese government during the SARS outbreak of 2003, and co-directed SARS research efforts in China with current Minister of Health Chen Zhu.
Judy A. Mikovits, PhD
Whittemore Peterson Institute for Neuro-Immune Disease
Dr. Mikovits spent more than 20 years at the National Cancer Institute in Frederick, MD, during which time she received her PhD in Biochemistry and Molecular Biology, investigating mechanisms by which retroviruses dysregulate the delicate balance of cytokines in the immune response. Formally trained as a cell biologist, molecular biologist and virologist, Dr. Mikovits’s research has focused on translational research in government, biotechnology and academic settings. Dr. Mikovits joined Whittemore Peterson Institute for Neuro-Immune Disease (WPI) in November of 2006 as the WPI’s first Research Director charged with establishing a translational research program aimed at identifying biomarkers and underlying causes of debilitating neuro-immune diseases. Dr. Mikovits has co-authored more than 40 peer-reviewed publications, including the “Detection of an Infectious retrovirus, XMRV, in Blood Cells of Patients with chronic fatigue Syndrome” (Lombardi et al. Science 2009).
Gail Moskowitz, MD
Gail Moskowitz, MD, specializes in Pathology and the medical leadership of blood and cord blood banks; she provides Healthcare Consultant services in the fields of blood banking, cellular therapeutics, laboratory medicine, pharmaceutical, medical-legal and regulatory affairs, and medical informatics. She is Board Certified and holds academic appointments as Lecturer in Pathology at Harvard Medical School and as Assistant Clinical Professor of Pathology at the Mount Sinai School of Medicine. Dr. Moskowitz has held several posts directing blood banks throughout New York and also served as Chairman of Pathology and Laboratory Medicine at St. Vincent’s Midtown Hospital in New York. More recently, she has served as the Medical Director of cord blood banks, both private and public. Dr. Moskowitz graduated from the Massachusetts Institute of Technology, where she was elected to Phi Beta Kappa, and the Mount Sinai School of Medicine. Dr. Moskowitz was a resident and chief resident in Anatomic and Clinical Pathology and the Morten Grove-Rasmussen Fellow in Immunohematology, all at the Massachusetts General Hospital. She is active in the AABB and serves on the AABB’s Cellular Therapies- Standards Program Unit and on the Board of Directors and on the Scientific and Medical Advisory Panel of the Parent's Guide to Cord Blood Foundation.
Susan L. Stramer, PhD
American Red Cross
Susan Stramer received her BS and MS degrees in Biology and Chemistry from Northern Illinois University where her research interest was water microbiology. She received her Ph.D. from the University of Wisconsin-Madison in Bacteriology with a minor in Toxicology in 1984. Her research focused on poliovirus survival in water and wastewater as a model system for water-borne enteric viruses. She then spent four years as a postdoctoral fellow at the U.S. Centers for Disease Control and Prevention (CDC) at the Hepatitis Branch in Phoenix, AZ and then in Atlanta, GA working with novel culture and quantitative methods, and molecular characterization of various isolates of hepatitis A virus. Following that, she was employed at Abbott Laboratories in their Diagnostic Division for nine years working in the areas of product development, R&D, and scientific affairs in support of hepatitis and retroviral assays. During her time at Abbott, she managed manufacturing, support and product development for most of the blood donor screening assays. In 1995, she joined the American Red Cross as Laboratory Director for the National Confirmatory Testing Laboratory. She now serves as the Executive Scientific Officer at the Scientific Support Office within Biomedical Services’ Medical Office where she provides scientific leadership in the area of infectious diseases for the National Testing Laboratories and blood collection regions of the Red Cross. Dr. Stramer has published more than 100 papers and has been a representative on numerous committees of the AABB and the International Society of Blood Transfusion, including serving on the AABB Board of Directors for the Mid-Atlantic district (2004-2008), as Secretary Treasurer (2009-2010) and now as the Vice President. She is also a liaison to the Transfusion Medicine Committee of the College of American Pathologists and a member of the Scientific Advisory Committee of HemaQuebec. Along with collaborators, Dr. Stramer was a recipient of the Charles C. Shepard Science award from the CDC in 1999 and was nominated for the same award in 2004 and 2009. She has also won the American Red Cross Tiffany Award for Employee Excellence in 2002 and the Spirit of Excellence Award in 2003. She was also honored in 2010 as the recipient of the Perkins Award and Lectureship in recognition of her contributions to the understanding of transfusion-transmitted infectious diseases, and the implementation of evidence-based measures to reduce their risk and assess their impact.
This event is funded in part by the Life Technologies™ Foundation.
Transfusion-Transmitted Pathogens: Strategies to Prevent Transmission
Gail Moskowitz, MD, Healthcare Consultant
Many transfusion-transmitted pathogens have been identified, including bacteria, viruses, and parasites. While some, including human immunodeficiency virus (HIV) and hepatitis C virus (HCV), are potentially deleterious to all recipients, others, such as cytomegalovirus, may adversely affect only selected recipients. Although various testing methodologies are utilized on donated blood, other strategies are also employed to minimize the risks of transmission to recipients. This presentation will briefly address these practices and the current risks of contracting common transfusion-transmitted infections. In addition, examples illustrating the need for practices besides testing will be discussed, and brief mention will be made of different requirements for different products.
Infectious Disease Risks for Transfusion Safety; Past, Present and Future
Susan L. Stramer, Ph.D., American Red Cross
Over the last 30 years, HIV, HCV and HBV have been the focus of blood safety. Most recently, screening for WNV RNA, Trypanosoma cruzi antibodies and bacterial culturing of platelets have been introduced in response to risks posed by different exposures in our donor population. Current, per-donation residual risks are estimated at 1:1,467,000 for HIV and 1:1,149,000 for HCV. Although higher, prior to the widespread implementation of HBV NAT, the HBV per donation residual risk from the same American Red Cross donor population is estimated at 1:280,000-1:357,000, and the residual risk of bacterial sepsis from platelets even following the introduction of culture methods remains at ~1:100,000. Against this background, there are increased demands to look at different mitigation strategies to address risks from newly identified or emerging infectious disease (EID) agents. The most recent introductions, WNV and T. cruzi, may be the last for which the existing paradigm of screening interventions that have initially relied on testing each donation are used. The remaining risks from EID agents are unpredictable but a committee of experts from the AABB Transfusion Transmitted Diseases committee assembled and published a Supplement to Transfusion (Aug 2009) summarizing what is currently known regarding 69 EID agents including XMRV (http://www.aabb.org/Content/About Blood/Emerging Infection Disease Agents/eid.htm). Of the 69, Babesia, dengue viruses and the vCJD prion are of the greatest concern related to blood safety and appropriate interventions. Pathogen reduction/removal was addressed as a proactive approach to reducing and perhapseliminating such agent threats.. Vigilance and creative approaches to addressing the emergence of such agents will be discussed with a focus on dengue viruses..
W. Ian Lipkin, MD, Columbia University
Recent advances in nucleic acid diagnostic methods have revolutionized microbiology by facilitating rapid, sensitive microbial surveillance and differential diagnosis of infectious diseases. Implementation of these methods may enable intervention when the prognosis is optimal for limiting replication, dissemination, transmission, morbidity and mortality. It may also reveal unappreciated links between infection and chronic diseases. In this lecture I will discuss mechanisms of microbial pathogenesis, routes to proving causation, and a staged strategy for surveillance and discovery. In reviewing the strengths and limitations of various analytical platforms, I will provide examples that illustrate how each platform can be used to investigate clinical problems.
Disease Associations of XMRV and MLV-Related Viruses
Judy A. Mikovits, PhD, Whittemore Peterson Institute for Neuro-Immune Disease
A new human retrovirus first associated with QQ variant RNaseL a gene in the hereditary prostate cancer gene locus, in prostate cancer in 2006. Detection of integration sites in unmanipulated prostate tissue; demonstration of neutralizing antibody and in situ hybridization for XMRV, supports XMRV as a human retroviral infection associated with prostate cancer. Although in the absence of direct sequencing it cannot be rule out the reactivity can be to related MLV viruses. In 2009 using a classical virology approach of viral isolation and transmission, electron micropscopy, serology and PCR, Lombardi et al demonstrated the first isolation of XMRV from blood from patients with chronic fatigue syndrome (CFS) predominately from the west coast of the United States. In 2010, Lo et al. extended these studies by detecting nucleic acids of MLV-related variants in the peripheral blood mononuclear cells of CFS from the northeastern United States suggesting additional strains capable of infecting humans exist. In a study of 300 CFS patients, 13developed lymphoproliferative disorders. Of those tested, 11/11 were positive for XMRV and 9/9 positive for clonalTCR gamma rearrangements. Spontaneous development of four immortalized B cells lines occurred during culture of cells from CFS patients. Three developed from B cells isolated from the peripheral blood (two of whom had B cell lymphoma) and one from a bone marrow biopsy. The B cell lineshave a mature CD20+, CD23+ phenotype and produce infectious XMRV. Virus production occurred despite extensive hypermutation of the proviruses in these cells by APOBEC3G. Therefore, XMRV infection may accelerate the development of B cell malignancies by either indirect chronic stimulation of the immune system and/or by direct infection of the B-cell lineage. Since viral load in peripheral blood is low, these data suggest that B cells in tissues such as spleen and lymph nodes could be an in vivo reservoir for XMRV. We have also identified an inflammatory cytokine and chemokine signature that distinguishes XMRV infected CFS patients from healthy controls with 94% sensitivity and specificity Monitoring immune dysfunction affords the opportunity to begin to understand the pathogenesis of XMRVs. In addition to these data, recent advances in developing tests for detection and characterization of XMRV–variants will be also be discussed
What’s next? Emerging Challenges to a Safe Blood Supply
Debra Kessler RN, MS, New York Blood Center
Blood borne pathogens of major concern in the last 40 years, predominantly HIV, HBV and HCV, have largely been addressed. New testing technologies for these viruses, including nucleic acid testing, have drastically reduced the risk of transfusion transmission. Yet new emerging infections, particularly those transmitted via insects, are increasing in the population. Infectious agents where testing is currently not available include those that cause Dengue fever and babesiosis. Approaches to protecting the blood supply from emerging threats, including creating new tests and pathogen inactivation, will be discussed. In addition I will offer some thoughts on whether we should test everyone for everything.
Protecting the Blood Supply from Emerging Pathogens
Sanjai Kumar, PhD, Food and Drug Administration
In recent years, the combination of laboratory testing and risk-based donor questionnaires has significantly reduced incidents of several once common transfusion-transmissible infections in the United States and other industrialized countries. Recent advances in pathogen detection technologies (nucleic acid-based testing and improved antigen and antibody detection) will improve next generation of donor screening tests to detect very low pathogen loads in donor blood. However, there are no FDA-approved laboratory tests for many emerging and potentially important pathogens that are either currently endemic in the US, have caused recent outbreaks in the US, or are epidemic in other parts of the world. These undetected infectious agents present a serious risk of infecting donors and pose a potential threat to the continued safety and availability of the US blood supply. This presentation will address threats to the blood supply from a number of infectious agents not yet interdicted by either donor testing or by questionnaires and describes some of the ongoing efforts in this regard at CBER, FDA.
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