Monday, March 6
8:00 Registration and Morning Coffee, Poster Set-Up
8:45 Chairperson's Opening Remarks
Existing and Emerging Pathogens
("know thy threats")
|9:00 OPENING KEYNOTE LECTURE
Emerging Pathogens and Blood Products: What to Do or Not, and Why
Dr. Thomas R. Kreil, Director of Global Pathogen Safety, Baxter Bioscience, Austria
Beyond the potentially unfortunate impact that emerging pathogens may have on affected individuals, these agents can also contaminate the supply of blood products. As experienced in earlier outbreaks, the use of these life-saving medicinal products can then become a vehicle further amplifying the spread of the respective agent. Consequently, many measures to enhance the safety of blood products have been implemented, yet the measures that can be taken are intrinsically different for the different classes of products derived from blood. Labile blood products for transfusion still derive their safety margins from the selection of appropriate donors and subsequent donation testing, whereas for stable blood products, i.e. plasma derivatives, pathogen reduction steps incorporated into the respective manufacturing process represent a most significant reduction of risk beyond selection and testing. Recently emerging agents, the measures taken to ensure the safety of blood products and the experience gained will be discussed.
9:45 West Nile Virus in Blood Products
Dr. Theresa L. Smith, MPH, LCDR, USPHS, Surveillance and Epidemiology Activity, Arboviral Diseases Branch, Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention
The talk will cover the history of West Nile virus transmission through blood since 2002. A brief description of the response by blood banks, FDA, and CDC to the problem will be given. Finally, the current state of safety efforts and risks will be covered.
10:15 Potential Causes of "Silent" Hepatitis B Infections
Dr. Lawrence A. Baker, Principle Staff Scientist, Manager, Infectious Disease Immunoassay Development, Bayer Diagnostics
A look at the impact of assay sensitivity, mutations, and other factors on the ability to detect low level or occult HBV infections. Published examples of mutant detection in occult infection will be reviewed. Data will also be presented on relative HBsAg assay sensitivity and its role in detection of silent infections.
10:45 Coffee Break, Poster Viewing
11:30 KEYNOTE PRESENTATION
Emerging Pathogens, Blood Safety, and Public Health
Dr. Matthew J. Kuehnert, M.D., CDR, U.S. Public Health Service, Assistant Director for Blood Safety, Centers for Disease Control and Prevention (CDC)
This talk will outline approaches to emerging threats to blood safety. Recent investigations and study of the magnitude of these blood safety threats have brought an array of viruses, bacteria, parasites, and prions to our attention. Sometimes, these threats may come to our attention through detection of transfusion-related illness, or in other ways, such as through organ and tissue transplant-related transmission or community outbreaks. Surveillance of known and unknown pathogens is critical for recognition and development of adequate interventions related to blood, organ, and other tissue safety, and sometimes, these data are in turn helpful in advancing public health.
Detecting and Screening Technologies
("find thy threats")
12:15 Enhanced Signal Amplification Systems for Immunoassays
Dr. Subhash Dhawan, Senior Investigator, Division of Emerging and Transfusion Transmitted Diseases, FDA
In an attempt to increase the sensitivity of existing diagnostic assays, immunoglobulins were chemically modified to conjugate multiple labels. The use of these modified immunoglobulin conjugates substantially increased the sensitivity of HIV-1 EIA and HIV-1 Western blot assay, and could potentially help detect HIV-specific antibodies in the early phase of HIV infection.
12:45 Emerging Technology Showcases
1:15 Lunch on Your Own
2:30 Lowering the Detection Limits of HIV Viral Load using Immuno-PCR
Dr. Niel Constantine, Professor, Department of Pathology, University of Maryland School of Medicine
The detection of less than 50 RNA copies/mL of HIV in blood could further decrease the window period, and identify more infected blood units. Approximately 3,000 molecules of HIV p24 antigen are present per virion as compared with two copies of RNA, allowing a larger number of targets to be detected. We have developed a signal amplification method, Immuno-PCR, to detect HIV p24 antigen, and attained detection limits into the attogram/mL range (1,000 molecules). In addition, the method detected 42% of blood samples from infected persons that had undetectable viral loads (<50 RNA copies/mL) by standard nucleic acid tests. The Immuno-PCR method for detection of HIV p24 antigen has shown the potential to further protect the blood supply. The method has also been applied for the ultra-low detection of prion protein.
3:00 Selected Oral Poster Presentations
Several poster presenters will be given the opportunity to present a brief oral presentation of their work. The presentations will be selected from all abstracts submitted prior to the deadline on February 3rd, 2006.
3:30 Refreshment Break, Poster Viewing
4:15 Nanoparticle-Based Bio-Bar Code Amplification (BCA) Assay for Rapid and Sensitive Detection of HIV-1 RNA and Capsid Protein (p24) in Plasma
Dr. Shixing Tang, Scientist, Molecular Virology, FDA CBER
There is an increasing need for new tools to facilitate detection of multiple pathogens in clinical samples to reduce costs and improve diagnosis and blood safety. Nanotechnology is being increasingly evaluated and applied to biomedical testing. New diagnostic tools based on nanoparticles offer some unique advantages for disease diagnosis and blood screening. A new, ultra sensitive technique referred to as Bio-barcode amplification (BCA) assay has been successfully developed to detect attomolar concentrations of antigens and nucleic acids. We will discuss the application of the BCA technology for detection of HIV-1 RNA and capsid protein (p24) in plasma from HIV-1 infected individuals. The technique is based on a set of chemical probes (nucleotide oligos or antibodies) that are used to tag disease markers: viz. protein or DNA/RNA and a bio-bar code sequence that is used indirectly to "amplify" the signal of the markers.
4:45 Bacterial Screening of Platelet Concentrates by Real-Time PCR
Dr. Henk W. Reesink, Sanquin Diagnostic Services
A real-time (RT)-PCR was developed using primers and probes of universal sequences of 16S ribosomal RNA region present in all bacteria. Since isolation and amplification chemicals are contaminated with various amounts of bacterial DNA, these reagents (MagNa Pure/Taqman) were cleaned by filtration and restriction enzyme digestion. The sensitivity of the current assay is 50 CFU/mL. Preliminary studies show that this PCR compared well with semi-automated culturing (BacT/Alert) with respect to sensitivity and specificity, whereas performance time of PCR was only 4 hours.
5:15 Panel Discussion:
Pathogens and their Detection - Where Are We and Where Are We Going?
6:00 End of Day One
For more information please contact:
Margit Eder, Ph.D., Conference Director, Cambridge Healthtech Institute
Phone: 781-972-5478, Fax: 781-972-5425
For sponsorship or exhibiting information, please contact:
Suzanne Carroll, Manager, Business Development
Phone: 781-972-5452, E-mail: email@example.com