WEDNESDAY, AUGUST 20
8:00-8:30 am Morning Coffee
VISION FOR POC DIAGNOSTICS:
Clinical Need Driving Technology Development
8:30 Chairperson’s Remarks
Brenda J. Korte, Ph.D., Program Director, Discovery Science & Technology, National Institute of Biomedical Imaging and BioEngineering, NIH
8:40 Developing Diagnostics for Global Health Applications
Roger Peck, Research Scientist, Diagnostic Development, PATH
This talk will focus on the parallels and differences between the characteristics of diagnostics for POC and home care settings in the developed world and diagnostic testing in developing countries. We will show examples of tests that are being developed for global health settings, including immunoassays based on the immunochromatographic strip test platform and nucleic acid assays on various minimally- or non-instrumented platforms. Further, we will introduce the new Center for Point-of-Care Diagnostics for Global Health (GHDx Center) and outline our main activities over the next years.
9:10 Rapid Multipathogen Detection for POCT and National Disaster Readiness
Richard F. Louie, Ph.D., U54 Center Fellow, UC Davis-Lawrence Livermore National Laboratory Center for Point-of-Care Technologies
The objectives are a) to provide an overview of the performance of multiplex PCR for detection enhancement of bacteremia and fungemia (Critical Care Medicine 2008;36:in press); b) to describe our UC Davis-LLNL Point-of-Care Technologies Center program including the development of POC isothermal loop-mediated amplification (LAMP) detection, one for community hospital settings and one deployed on Disaster Medical Assistant Teams (DMATs); and c) to discuss the results of needs assessment for critical-emergency-disaster care.
9:40 POC for Neurologic Emergencies, Diseases and Disorders
Fred R. Beyette, Jr., Ph.D., Associate Professor, Department of Electrical & Computer Engineering and Computer Science, University of Cincinnati
Neurologic emergencies such as stroke, head injury, and drug abuse are a leading cause of disability in the USA, and can lead to rapid
and irreversible brain damage. For example, it is estimated that 1 million brain cells die every minute during an ischemic stroke. Hence, it is often said that in an emergency, “time is brain.” The development of point-of-care technologies that can provide timely diagnostic information is critical for improving patient outcomes in a neurologic emergency. This talk will highlight the University of Cincinnati Point-of-Care Center for Emerging Neurotechnologies and its focus on developing new and innovative technologies to meet this critical medical need.
10:10 Coffee Break, Exhibit and Poster Viewing
10:45 Progress of a Center for Development of Point-of-Care Tests for Sexually Transmitted Diseases
Charlotte A. Gaydos, M.S., M.P.H, Dr.P.H., Associate Professor of Medicine, Johns Hopkins University Division of Infectious Diseases, International STD Laboratory
Our Point of Care (POC) Test Center is composed of 5 Cores: 1.Testing Core, 2. Development Core, 3. Assessment Core, 4. Training Core, and 5. Administrative Core. Core 1 is testing the acceptability of patients and ability to perform their own test for POC test HIV and their own tests for trichomonas. It is also developing a microwave-accelerated, metal-enhanced fluorescence (MAMEF) for POC for chlamydia. Core 2 is soliciting proposals for scientists to develop new POC tests. Cores 3 and 4 are assessing needs required for POC tests and providing training for developers, while Core 5 is providing coordination for the center. The progress of the center will be discussed.
11:15 PANEL DISCUSSION WITH SPEAKERS:
- Integrating system with new components, sensing and sample prep
- Challenging systems with real world samples
- Incorporating the user perspective for POC tech development
- Is the best approach needs driven?
- Bringing perspective of business models for POC- how is it different from other markets?
- Wireless systems
11:45 Luncheon Presentation (Sponsorship Available) or Lunch on Your Own
APPLICATION AREAS- Bringing Together Technology with Clinical Needs
1:00 pm Chairperson’s Remarks
Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC
1:10 Point-of-Care Testing - The Best Designed POCT ‘Oft Go Awry’
Valerie Ng, Ph.D., M.D., Chairman, Pathology and Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital
Point-of-care test (POCT) devices are designed to be simple to use and yield accurate results. Yet in the usual POCT setting, users often perform POCT incorrectly. This in turn leads to inaccurate results. Why? This talk will present the myriad of factors identified and related to incorrect POCT performance in the real world. The downstream clinical impact of inaccurate POCT results will be presented. Consideration of these real-life factors influencing how POCT is actually performed is key to designing POCT that will actually be performed as intended.
1:40 Wish list for POC tests
Diana R. DeHoyos, MS, MT (ASCP), Point-of-Care Testing Coordinator, University of Texas Medical Branch
SYSTEMS FOR CARDIOLOGY
2:10 Chairperson’s Remarks
James H. Nichols, Ph.D., DABCC, FACB, Associate Professor of Pathology, Tufts University School of Medicine, Medical Director, Clinical Chemistry, Baystate Health
2:20 Cardiac Markers: To Point-of-Care or Core Laboratory, That is the Question!
James H. Nichols, Ph.D., DABCC, FACB, Associate Professor of Pathology, Tufts University School of Medicine, Medical Director, Clinical Chemistry, Baystate Health
Patients with chest pain and cardiac symptoms need rapid test results. Consensus recommendations call for a maximum of 30 – 60 minutes for cardiac marker testing from the time the physician orders the test to receipt of results. What is the optimum way for the laboratory to meet this need? Point of care testing is fast, but requires significant management to maintain quality, but laboratory results may take longer. This presentation will discuss the clinical need and debate the advantages and disadvantages of point-of-care testing for cardiac markers.
2:40 Point of Care Cardiac Marker Testing - How to Bring the Value of the Lab to the Patient
Steve Miller, Ph.D., Head of Decentral Network Solutions and Services, Roche Professional Diagnostics, Acute Diagnosis Solutions
3:10 Refreshment Break, Exhibit and Poster Viewing
SYSTEMS FOR INFECTIOUS DISEASE
3:40 Chairperson’s Remarks
Valerie Ng, Ph.D., M.D.
3:45 The BioSeeq®-Vet PCR System: Portable PCR, Automated Sample Preparation, and Highly Multiplexed LATE-PCR for Avian Flu Detection
John W. Czajka, Ph.D., M.B.A., Vice President of Technology Acquisition, Smiths Detection
Smiths Detection has developed the BioSeeq®-Vet PCR System, a field-portable platform for detection of biological threats and infectious agents. The BioSeeq®-Vet System provides the ability to collect, process, detect, and identify infectious diseases through the use of unique nucleic acid isolation, amplification, and hybridization technologies. The instrument platform is a ruggedized, portable, battery-operated, four color thermocycler. The sample preparation and assay reagents are contained in a single-use disposable consumable that is driven by the instrument after the sample is loaded by the user. This system utilizes a novel amplification methodology, known as LATE-PCR, which enables multiplexed detection of 10 – 20 target organisms in a single sample reaction.
4:05 Catching Bird Flu in a Droplet
Jürgen Pipper, Ph.D., Senior Research Scientist, Institute of Bioengineering and Nanotechnology
With a few exceptions, the micro total analysis systems (TAS) demonstrated have failed to live up to the ideal of miniaturizing multiple laboratory tasks onto a single chip. One of the challenges is to interface the preparation of raw samples with downstream applications. Here, we show a microfluidic platform for detecting the highly pathogenic avian influenza virus H5N1 in a throat swab sample by magnetic manipulation of a free droplet encasing superparamagnetic particles. In an automated process, the viral RNA is purified, preconcentrated, and subjected to a real-time RT-PCR/melting curve analysis in less than half an hour.
4:25 New Respiratory Viral Panel
Richard Janeczko Ph.D., Vice President, Emerging Markets and Technology, Luminex Molecular Diagnostics
4:45 Rapid Nucleic Acid Diagnostics for the Detection of Infectious Disease
Andrew Miller, Ph.D., Vice President, R&D, Ionian Technologies Inc.
Ionian’s rapid isothermal DNA and RNA amplification and detection technologies allow for unparalleled detection of bacterial and viral pathogens in 5-10 minutes. The sensitivity and specificity of DNA/RNA amplification provide significantly improved performance relative to immunoassays, allowing for detection of less than 50 genome equivalents. Results can be read-out with a variety of methods, including various fluorescence approaches and with a colorimetric dipstick. Our detection technology combined with a simple heating/detection unit provides nucleic acid testing in a point-of-care format, without requiring laboratory-trained personnel. In addition to the POC opportunities, Ionian is also commercializing assays for biothreat detection, agriculture applications, food safety, and environmental monitoring.
5:05 PANEL DISCUSSION
Moderator: Linda McAllister, M.D., Ph.D., Vice President, Diagnostics, Arbor Vita Corp.
- Qualities of a well-designed system (accounting for human error issues)
- Engineering around QC issues
- Managing risk and developing safeguards
- Use of case controlled studies and internal controls
- Demonstrating clinical utility in development of test
- Coordinating testing, deciding to do POC vs. central lab: how soon do you need results?
- Evidence to support POC testing
Panelists:
Valerie Ng, Ph.D., M.D.
Diana R. DeHoyos, MS, MT (ASCP)
James H. Nichols, Ph.D., DABCC, FACB
6:00 Close of Conference