Cambridge Healthtech Institute’s Inaugural
Rapid Critical and Urgent Care Testing
Technologies and Approaches for Faster and Error Free Results
August 18, 2017 | Grand Hyatt Washington | Washington, DC
Patient management in critical, acute and urgent settings relies heavily on the laboratory results, and this trend is growing from year to year. The time to results, the accuracy of testing and the possibility of using smaller samples are important features and identifiers of high quality analyzers and POC systems that are employed in emergency rooms, critical care units, hospital wards or operating rooms. Cambridge Healthtech Institute’s Inaugural Rapid Critical and Urgent Care Testing symposium is designed as a knowledge and experience exchange for POC experts, directors of critical care testing from hospitals and medical centers, inventors and scientists from IVD companies as well as critical and urgent care clinicians.
Final Agenda
Recommended Short Course(s)*
SC3: Technologies, Applications and Commercialization of Point-of-Care Diagnostics
*Separate registration required
FRIDAY, AUGUST 18
8:00 am Registration & Morning Coffee
8:25 Chairperson’s Opening Remarks
Ellis Jacobs, Ph.D., DABCC, FACB, Adjunct Associate Professor of Pathology, Mount Sinai School of Medicine; Director, Scientific Affairs, Alere, Inc.
8:30 KEYNOTE PRESENTATION: A Global View of Unmet Needs in Point-of-Care Testing
Gerald J. Kost, M.D., MS, Ph.D., Director of Clinical Chemistry and Point-of-Care Testing, Professor of Pathology and Laboratory Medicine, University of California Davis
Identifying unmet needs tells us what point-of-care (POC) technologies to develop, where to invest, and how to implement them. The Ebola crisis proved unequivocally the need for POC testing to help stop outbreaks, and the emergence of antimicrobial resistance has stimulated a new wave of molecular POC testing for rapid targeted therapy. These dynamic events, and simultaneously our responsibility to decrease healthcare expenditures and address traumatic brain injury, early diagnosis of stroke, and other life threatening conditions, are shaping the future of POC solutions worldwide.
9:00 How to Achieve Concordance between POCT and Central Laboratory Methods
Jeffrey A. Dubois, Ph.D., Vice President, Medical & Scientific Affairs, Nova Biomedical
The session will address issues for four methods performed in the central lab and at the POC (glucose, creatinine, lactate and hemoglobin A1C), define medical concordance and how these tests are affected, present new statistical methods for evaluating test methods, and define approaches to achieving concordance between central and POCT. The panel of experts will present the historical, current, and future of assessment methods for each of these analytes and factors that contribute to medical discordance.
9:30 Preanalytical and Analytical Errors in Patient Care and Biomarker Research
Zhen Zhao, Ph.D., Clinical Chemist, Director of General Chemistry, Associate Director of Clinical, Chemistry Fellowship Training Program, NIH Clinical Center
Reliable test results set the foundation for quality patient care and clinical biomarker research. This session will discuss factors contributing to preanalytical and analytical errors, and strategies to prevent, detect, and correct these errors.
10:00 CO-PRESENTATION: POCT vs. Core Lab Testing: Managing Control and Quality
Peter Koerte, Ph.D., President, Point of Care Diagnostics, Siemens Healthineers
Felicity Dempsey, MSc,FAMLS, POCT Specialist Scientist, Biochemistry, St James Hospital
Despite the advance in point-of-care (POC) technology, concerns remain with the lack of quality and control associated with POC testing. POC middleware is able to address some of these issues as devices become more and more connected. The presentation will focus on the benefits of having an IT “backbone” in place to effectively mitigate key concerns about device management, operator training and recertification, and quality control.
10:30 Coffee Break with Poster Viewing
11:00 Intraoperative Measurements of Parathyroid Hormone: Current Use and Future Needs
John Toffaletti, Ph.D., Professor, Pathology, Director of Blood Gas and Clinical Pediatric Laboratories, Duke University Medical Center
Measurement of intraoperative parathyroid hormone (PTH) has been used since about the mid-1990s as an aid to removing the proper type and amount of adenomatous parathyroid tissue. Use of this testing has increased such that, at many medical centers, intraoperative measurements of PTH have become a standard of care for surgical treatment of primary hyperparathyroidism and especially for difficult cases and whenever a reoperation is necessary. At Duke Medical Center, the standard number of measurements per case has increased from 5 to sometimes 20 for difficult cases. Our yearly test volume has increased steadily from about 400 in 2006 to about 1250 in 2016. Providing these measurements requires methods that have relatively fast turnaround times of less than 15-20 minutes. However, the methods for rapidly measuring PTH all have shortcomings of some type. Because our analyzers are located in the surgery area, our technologists typically spend at least 4 hours on each case. This presentation will focus on the clinical need for intraoperative PTH measurements, the challenges of providing this testing, the current methods and the improvements in methods needed for the future.
11:30 High Sensitivity Troponin: Technology and Applications Update
Robert H. Christenson, Ph.D., Professor, Pathology, University of Maryland School of Medicine
Blood-based biomarkers have been extensively studied in a range of cardiovascular diseases and have established utility in routine clinical care, most notably in the diagnosis of acute coronary syndrome (e.g., troponin) and the management of heart failure (e.g., brain-natriuretic peptide). The role of biomarkers is less well established in the management of valvular heart disease (VHD), in which the optimal timing of surgical intervention is often challenging.
12:00 pm Spotting and Surviving Sepsis
Ellis Jacobs, Ph.D., DABCC, FACB, Adjunct Associate Professor of Pathology, Mount Sinai School of Medicine; Director, Scientific Affairs, Alere, Inc.
Early recognition and treatment of sepsis improves outcomes. After overviewing the scope of sepsis morbidity and mortality, the role of biomarkers in sepsis screening, diagnosis, risk stratification, and monitoring of response to therapy will be described. Multiple factors must be considered when evaluating sepsis testing and results. Situations where point-of-care testing might benefit patients with a suspected or confirmed diagnosis of sepsis will be identified.
12:30 Intelligent Quality Management (IQM2) for Detecting Transient Sample Measurement Errors
Prasad V. A Pamidi, Ph.D.,Director Of Sensor Development, R&D, Instrumentation Laboratory, A Werfen Company
Transient errors occur within a sample measurement causing erroneous sample results. These errors can come and go without any detection and can affect a single sample or subsequent samples. Typical sources of transient errors are bubbles, microclots, interfering substances, etc. Intelligent quality management IQM2 on the GEM Premier 5000 is designed to alert users on transient errors by analyzing electronic signal patterns collected before, during and after sample measurement process.
1:00 Enjoy Lunch on Your Own
1:30 Session Break
2:00 PANEL DISCUSSION: Trends and Challenges in New Technologies for POCT
Moderator:
Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH
- Recent trends in microfluidics-enables POCT
- Recent trends in cartridge based POCT
- Technical challenges in product development
- Regulatory and clinical requirements
- Future technological needs to be met
Panelists:
Peter Koerte, Ph.D., President, Point of Care Diagnostics, Siemens Healthineers
Chris Myatt, Founder and CEO, MBio Diagnostics
3:05 Refreshment Break with Poster Viewing
3:30 Chairperson’s Remarks
Ping Wang, Ph.D., DABCC FACB, Pathology and Laboratory Medicine, University of Pennsylvania
3:35 Challenges and Opportunities in Laboratory Monitoring of Direct Oral Anticoagulants
Ping Wang, Ph.D., DABCC FACB, Pathology and Laboratory Medicine, University of Pennsylvania
Direct oral anticoagulants (DOACs) provide rapid therapeutic effect and are considered relatively safe. However, it is important to evaluate the anticoagulation effect of DOACs at time of urgent bleeding control or urgent evaluation of surgery candidacy. For some DOACs, routine coagulation assays such as activated partial thromboplastin time (aPTT) or prothrombin time (PT) may be useful monitoring tests. For other DOACs, anti-factor Xa activity assay or direct measurement of drug concentration correlates well with therapeutic effect. In this presentation, existing laboratory solutions, their limitations and possible future method developments will be discussed.
4:05 Hemostasis and Coagulation Testing: The FDA Perspective
Lea Carrington, Ph.D., Director, Division of Immunology and Hematology Devices, CDRH, FDA
In vitro diagnostic testing is more frequently being assessed at or near the patient. This presentation will address the regulatory perspective and utilization of various hemostasis test methods in urgent care settings.
4:35 Close of Symposia Programs