Suzanne HancockSenior Development Scientist, GE Healthcare
From investigative microscopy to automated high content analysis: enabling approaches to improve the workflow when characterising and validating a multiplexed approach to studying the distribution and trafficking of intracellular proteins
Bio- Suzanne is a senior development scientist currently focused on user driven biological application support for the IN Cell Analyzer platform. Suzanne has extensive expertise in the fields of cell biology and molecular biology. She has been with GE Healthcare for over ten years during which time she has become an advanced user of automated imaging platforms and analysis software.
Presentation Abstract- Traditional manual microscopy offers valuable techniques to the cell researcher. Enabling high content imaging and analysis techniques employing high throughput, automated microscopy, facilitating many diverse cellular and small organism assays allows scientists to not only ask more questions but to ask questions that were not previously possible to answer using traditional methods. Greater throughput coupled with high resolution, high image quality restoration techniques and the crucial ability to measure multiple parameters simultaneously in the same cells, means that high content analysis assays are significantly more informative than traditional techniques. We look at a specific example of improving the workflow when characterising and validating a multiplexed approach to studying the distribution and trafficking of intracellular proteins.
Medical Director, Clinical Chemistry, Baystate Health, Professor of Pathology, Tufts University School of Medicine
Point-of-care testing: What is it and why does everyone want it?
Bio- James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology at Tufts University School of Medicine and Medical Director, Clinical Chemistry for Baystate Health in Springfield, MA. Jim received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Dr. Nichols was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions prior to moving to Massachusetts. James is responsible for Clinical Chemistry including core automated chemistry, immunoassay, endocrinology, toxicology/therapeutic drug analysis, estoteric and point of care testing conducted through Baystate Reference Laboratories, one of America’s largest hospital-based outreach programs. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.
Presentation Abstract- Point-of-care testing (POCT) is defined as diagnostic testing conducted close to the site of patient care, primarily by clinical staff. POCT is a rapidly growing sector of the diagnostic market due to several advantages over central laboratory testing: rapid turnaround time for results, small sample volume, wide menu of analytes, and portable testing devices. Despite its popularity, POCT raises concerns over the reliability of test results as the testing devices seem so simple, some are even available for over-the counter purchase, that staff with minimal to no training can pick up the device and perform testing. This has led to debate over the need for stricter quality regulations, documentation, and inspection of POCT practices in healthcare settings. There is a dichotomy over the added burden of quality control regulations versus the potential benefit of obtaining faster test results to overall patient outcome when hospitals and clinics consider adopting POCT. Despite the clear potential for improved outcomes, there are few publications where those outcomes have actually been achieved in real-world practice. With the complexity of management decisions in today’s healthcare environment, many factors can impact patient outcome besides just achieving a fast result. A rational approach to utilizing POCT will optimize not just result turnaround time, but the entire clinical pathway of care including acknowledgement of test results and the many other factors that can delay patient treatment and outcome. This presentation will introduce POCT, discuss the concerns over quality of test results, and offer suggestions for assuring quality and optimizing the incorporation of POCT into patient management strategies.
David Persing M.D. Ph.D.Chief Medical and Technology Officer, Cepheid
Decentralized Molecular Detection of Drug Resistant Organisms
Bio- Dr. David Persing is Executive Vice President and Chief Medical and Technology Officer at Cepheid in Sunnyvale, CA. David obtained a BA degree in Biochemistry from San Jose State University in 1979, and a combined MD-PhD degree from the University of California, San Francisco in 1988. He completed his residency in Laboratory Medicine at the Yale University School of Medicine, and then joined the Laboratory Medicine and Pathology Staff at the Mayo Clinic where he developed several extramurally funded research programs in infectious diseases. In 1992, he established and directed the Molecular Microbiology Laboratory at the Mayo Rochester campus, one of the first molecular diagnostics laboratories of its type in the country and gained an international reputation as a leader in the field. After his 10 year academic career, against the medical advice of most of his colleagues, he left the eternal security of a tenured Mayo position for a walk on the biotech "wild side". As Chief Scientific Officer at Corixa Corporation in Seattle until its acquisition by GSK in 2005, he headed research groups focused on innate immunity, vaccine development, and molecular diagnostics. From 2001 to 2005, he was principal investigator on two grants totaling nearly $18 M in the area of Toll-like receptor agonists and antagonists.
He joined Cepheid in 2005 in order to pursue his longstanding interest in making sophisticated molecular diagnostic testing more approachable and accessible. His R and D group at Cepheid has been supported by nearly $12M in grants from NIAID and the Gates Foundation via FIND for development of MDR-TB Diagnostics. He has authored over 230 peer-reviewed journal articles, including senior author publications in the New England Journal of Medicine, Science, and PNAS, numerous book chapters and reviews, and has served as Editor-in-Chief for 3 leading textbooks on molecular diagnostics, the most recent of which will be published by ASM in 2010. He is an inventor on 16 issued and 6 pending US and International patents, and was recently appointed Consulting Professor of Pathology at the Stanford University School of Medicine.
Presentation Abstract- Detection of drug-resistant organisms, especially those that cause hospital-acquired infections, has become an increasingly important role for the clinical laboratory. Conventional culture methods are too slow to be of use in the most effective hospital infection control strategies, which require rapid recognition and cohort isolation. Molecular methods based on PCR have improved turnaround time, but their dependence on batch-mode processing can stretch effective turnaround times to 24 hours or more. Cepheid has developed rapid cartridge based tests for several drug resistant organisms. These tests carry out automated sample extraction from crude clinical specimens such as sputum, blood, or swabs and use Real-time PCR to detect targets and internal process controls that are multiplexed in 4 to 6 color channels. Results are delivered in as little as 30 minutes in order to facilitate high-impact medical management or treatment decisions. Because each cartridge contains it own controls, tests can be run on-demand, in batches or one at a time, within the random-access GeneXpert system. Tests for different analytes, using different reagents and distinct thermal cycling conditions, can be run side-by side upon arrival in the lab, thus keeping effective turnaround time to a minimum. Data will be presented on detection of C. difficile, and drug resistant tuberculosis, along with data supporting decentralized testing strategies for both organisms.
Alan Wu Ph.D.Chief of Clinical Chemistry & Toxicology & Prof. Laboratory Medicine, San Francisco General Hospital and University of California, San Francisco
The Emerging Role of Pharmacogenomics in Clinical Research and Practice
Bio-Alan H.B. Wu, Ph.D., is Chief of Clinical Chemistry and Toxicology at San Francisco General Hospital and Professor of Laboratory Medicine, University of California, San Francisco. He received B.S. degrees in chemistry and biology at Purdue University, West Lafayette, Indiana, and a Ph.D. degree in analytical chemistry at the University of Illinois, Champaign-Urbana, Illinois. He completed a postdoctoral fellowship in clinical chemistry at Hartford Hospital. He is certified by the American Board of Clinical Chemistry in Clinical Chemistry and Toxicological Chemistry.Dr. Wu’s research interest has been in three areas within the field of clinical chemistry laboratory. He has been involved at the national and international levels with development and use of biochemical markers for cardiovascular disease including CK-MB, myoglobin, troponin, B-type natriuretic peptide, and markers of myocardial ischemia, and stroke. As also has a long history of analytical, clinical, and forensic toxicology. In both of these areas, Dr. Wu has co-authored the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines. More recently, Dr. Wu has developed research and clinical programs in pharmacogenomics in support of the UCSF clinical pharmacogenomics laboratory. Among the areas of interest include pharmacogenomics for anticoagulants, especially warfarin, chemotherapeutics (tamoxefin, irinotecan), and drugs that can induce hypersensitivity reactions (abacavir, anticonvulsants).
Presentation Abstract- Interindividual differences in drug responses, including both efficacy and toxicity are frequently observed for many diseases and correlate closely with clinical outcomes. Environmental influences only explain a limited portion of these variances. Pharmacogenomics aims to elucidate the genetic basis for interindividual differences in drug absorption, distribution, metabolism and elimination. With knowledge gained from this research, medications that would have poor efficacy or cause severe side effects could be avoided before they are prescribed, and drug doses could be adjusted to achieve maximal efficacy while minimizing adverse reactions. The translation of pharmacogenomics research into clinical testing will greatly improve medical practice. We describe the plans for a clinical pharmacogenomics lab to support clinical trials with the final goal of providing a routine testing service. Important pharmacogenomic tests today include CYP2C9 and VKORC1 for warfarin dosing, CYP2D6 for tamoxifen drug selection, CYP2C19 for clopidogrel drug selection and efficacy, HLA-B*5701, 1502, and 5802 for abacavir, carbamazepine, and allopurinol, respectively, for toxicity avoidance, and Kif-6 for statin drug efficacy.
Ellen Jo Baron Ph.D.Professor Emerita, Pathology; Stanford University, Director of Medical Affairs, Cepheid
What are our options for preventing early onset neonatal group B streptococcal disease in the era of molecular diagnostics?
Bio- Ellen Jo Baron, PhD, D(ABMM) is Professor Emerita of Pathology at Stanford University School of Medicine and former Director of the Clinical Microbiology and Virology Labs at
She holds a Ph.D. in Medical Microbiology from
Dr. Baron is very active in the field of diagnostic microbiology as a symposium presenter and author. For the World Health Organization, she co-developed the program for antimicrobial resistance detection and basic microbiology, which she presented in a number of resource-poor countries from 1995-1998 and again in 2005. In 2007 she developed a new basic microbiology training program for developing world, and it has been presented in Colombia, Laos, Cambodia, Botswana, Zambia, Mozambique, China, Panama, as well as in the U.S. The program will eventually be used throughout the entire developing world. Dr. Baron has been on the editorial boards of key clinical microbiology journals, and was a volume editor (bacteriology) for the ASM’s Manual of Clinical Microbiology for the last 4 editions. She has written or edited >30 books and chapters and is widely published in peer-reviewed journals in the area of diagnostic microbiology and infectious diseases. She was the recipient of the ASM’s BioMerieux Sonnenwirth Award for Leadership in Clinical Microbiology in 2000 and the Alice Evans Award for serving as a role model for women in the field in 1997. She won the 2003 Kenneth L.Vosti Teaching Award from the Infectious Diseases Division at Stanford.
She is currently the Director of Medical Affairs for Cepheid, a high-technology molecular diagnostics company in
Presentation Abstract- The incidence of early-onset neonatal disease due to group B streptococci (GBS) has decreased dramatically in the
Steven BinderDirector Technology Development, Bio-Rad Laboratories
Protein Arrays in Diagnostics
Bio-Steven R. Binder is the Director of Technology Development for the Clinical Diagnostic Group at Bio-Rad Laboratories, a position he has held since 2000. His work involves the evaluation of novel technologies for clinical diagnostics, as well as new biomarkers. After receiving a B.A. in History and Science from Harvard University, Steve worked in hospitals as a clinical chemistry supervisor as a methods development specialist. He joined Bio-Rad in 1983, where he developed clinical chromatography methods for fifteen years. Since 1998, Steve has been occupied with the technology of protein arrays, especially autoimmune biomarkers and methods. He has authored over 20 papers in peer-reviewed journals and has received 10 US patents, which include his work on pattern recognition methods. Steve serves on the editorial board of IVD Technologymagazine.
Presentation Abstract - The introduction of array technologies for DNA has greatly accelerated the rate of discovery in medical research. In the clinical laboratory, DNA arrays have been applied to assays as diverse as HLA typing and respiratory viral testing. Protein arrays present unique challenges and their application to both medical research and clinical diagnostics has progressed more slowly. The range of applications today continues to expand, encompassing autoimmune, serology, and IgE antibodies, cytokines, and drugs of abuse testing. Many new technological approaches are in development, including bar-coded arrays and label free detection. In this presentation I will review the challenges facing both planar and bead-based arrays for proteins, including the development requirements and the regulatory requirements facing algorithm—driven diagnostic methods. I will also describe several approaches to tumor marker arrays and their potential importance for early diagnosis of cancers.
Robert Christenson Ph.D.Director; Rapid Response Laboratories; Professor of Pathology; Professor of Medical and Research Tec, University of Maryland School of Medicine
Markers of Heart Failure: Natriuretic Peptides
Bio- Dr. Christenson is Professor of Pathology and Professor of Medical and Research Technology at the University of Maryland School of Medicine in
Presentation Abstract- Congestive heart failure (CHF) affects over 5.3 million Americans. HF is responsible for ~1 million hospitalizations each year and is the most common reason for hospitalization in the US in patients >65 years of age. There are approximately 285,000 HF deaths each year in the US, and the disease has an annual cost burden of $29.6 billion. Biomarkers of HF have revolutionized the ability diagnosis, risk stratify and manage HF.
Guidelines for utilizing B-type natriuretic peptide (BNP) and its biologically inactive co-metabolite N-terminal proBNP (NT-proBNP) in suspected acute HF patients have been established. In this acute clinical setting, either BNP or NT-proBNP is recommended to rule out or to confirm the diagnosis of heart failure among patients presenting with ambiguous signs and symptoms (1). Before availability of BNP and NT-proBNP, CHF was diagnosed using clinical tools alone. Natriuretic peptide measurements are also important for risk stratification of patients because there is a disconnect between clinicians’ perception of HF severity and actual risk of adverse events. Prediction of adverse events, i.e. 30- and 90-day mortality, are better reflected by BNP or NT-proBNP values (3). It is important to note that there are important caveats in BNP and NT-proBNP interpretation including renal insufficiency, obesity, and “gray zone” values. A randomized controlled trial compared BNP testing with no BNP testing, finding a significantly shorter hospital stay and savings of about $1,500 USD in patients who received BNP testing (3).
After attending this session participants will better understand the role of BNP and NT-proBNP in diagnosis, risk stratification and management of HF patients.
William Clarke, Ph.D.Associate Professor of Pathology, Johns Hopkins Medical Institutions
Critical Care Analyzers – Not Just Blood Gases Anymore
Bio- Dr. Clarke received his Ph.D. in Analytical Chemistry from the
Dr. Clarke has published 40 papers in journals such as Analytical Chemistry, Journal of Chromatography, Clin Chim Acta, and Annals of Surgery, as well as 22 book chapters. He is also the editor of Contemporary Practice in Clinical Chemistry, published by AACC Press. Dr. Clarke was the recipient of the 2004 George Grannis Award from the NACB for excellence in research and publication by a young investigator, and also the 2005 AACC TDM/Toxicology Division Young Investigator Award.
Presentation Abstract- For many years, blood gas analysis instruments have been the workhorse of critical care laboratories that support intensive care units and intra-operative procedures. As technology has become more advanced, simple tests such as glucose and electrolytes have been added to the critical care testing menu. More recently, we have seen a greater expansion of the testing menu along with proposed developments of companion devices that will be able to perform immunoassay and coagulation testing. This presentation will discuss newly available and “just around the corner” critical care tests, considerations for implementation of these expanded critical care menu options, and challenges associated with implementation of decentralized testing using these analyzers.
Christopher deFilippiAssociate Professor of Medicine, University of Maryland Medical Center
TBD
Bio- Dr. DeFilippi received his M.D. from the University of Rochester. He was a resident at both the University of Texas-Southwestern/Dallas VA Medical Center and at University Hospital in Boston, and served a fellowship in cardiology at the University of Texas-Southwestern. Dr. DeFilippi's special interests include echocardiography, cardiac catheterization, post-transplant surveillance and management of patients with kidney disease. His specific research interests are in the area of cardiac biomarkers where he has evaluated multiple markers including the cardiac troponins and natriuretic peptides for early detection of disease and prognostication in patients with chronic kidney disease and the elderly. Recent investigator initiated work has included evaluation of several of the new "high-sensitive" troponin assays in subjects with chest pain and in those with chronic kidney disease.
Robert Fitzgerald Ph.D.Associate Professor, University of California, San Diego
Measurement of Testosterone in the Clinical Laboratory
Bio- Dr. Fitzgerald received his BS degree in Chemistry at Loyola College of Maryland, and his Doctorate in Pharmacology/Toxicology at the Medical College of Virginia/Virginia Commonwealth University. After two and a half years as a forensic toxicologist for the State of Virginia, he took a position as the Director of the Mass Spectrometry Laboratory at the San Diego VA Hospital.
Currently, Dr. Fitzgerald has a joint appointment as a Professor in the Department of Pathology at the University of California, San Diego and as the Associate Director of Clinical Chemistry at the VA Healthcare System in San Diego. He is board certified in toxicology and clinical chemistry by the American Board of Clinical Chemistry. His teaching responsibilities include acting as the course chairman for “Laboratory Medicine,” a required course for 2nd year pharmacy students, teaching a similar course to second year medical students, and educating pathology resident physicians.
Dr. Fitzgerald’s research interests focus on the use of mass spectrometry in clinical diagnostics. He has been active in developing MS based methods for analysis of testosterone and other biologically important compounds. A second major research area focuses on optimizing how cardiac biomarkers are used clinically, especially in terms of disease diagnosis and monitoring therapeutic interventions.
Presentation Abstract- The analysis of testosterone in the clinical laboratory has received a lot of attention recently due to several publications demonstrating significant differences between values determined by mass spectrometry (MS) and those determined by automated clinical analyzers. The objectives of this presentation are to:
1. Describe the clinical need for accurate testosterone measurements.
2. Provide an overview of the analytical issues related to testosterone measurements.
3. Describe analytical problems associated with immunoassay measurements of testosterone.
4. Describe basics of mass spectrometric measurements of testosterone.
5. Discuss path forward to improving the measurement of testosterone in the clinical laboratory.
Today many laboratories use immunoassay based methods, such as chemiluminescent and electrochemical techniques, combined with automation to perform testosterone measurements. These assays are useful for the diagnosis of hyper- and hypoandrogen states in men, but are often less than optimal when analyzing specimens from women and infants. The antigen-antibody reactions are relatively non-specific compared to chromatography linked mass spectrometric techniques. Mass spectrometry is poised to make major improvements in how clinical laboratories measure a variety of compounds, including testosterone. This presentation will cover the limitations of current immunoassays for testosterone measurements as well as a brief overview of MS based techniques.
Deborah French Ph.D.Clinical Chemistry postdoctoral fellowship program, San Francisco General Hospital, UC San Francisco
Measurement of Vitamin D by liquid chromatography-tandem mass spectrometry
Bio- Deborah is currently in a Clinical Chemistry postdoctoral fellowship program accredited by the Commission on Accreditation in Clinical Chemistry (ComACC) under the direction of Dr Alan Wu at the University of California-San Francisco and San Francisco General Hospital, San Francisco, CA. During this fellowship, she has been instrumental in the development of LC-MS/MS assays for use in the clinical laboratory, specifically for vitamin D measurement in serum, and opioid measurement in urine. Deborah completed her undergraduate degree in Biochemistry and Molecular Biology at the
Presentation Abstract- Vitamin D is an essential nutrient, and there is a growing appreciation of its clinical significance. In addition, there has recently been a lot of discussion as to the best method of measuring this analyte in serum. It has recently been established that Vitamin D deficiency in the general population is common, not just in high risk populations such as children and the elderly as previously thought. Vitamin D enters the circulation and is hydroxylated in the liver to 25-hydroxyvitamin D (25-OHD). 25-OHD3(vitamin D3; cholecalciferol) is formed from exposure to sunlight and in the diet from animal products whereas 25-OHD2 (vitamin D2; ergocalciferol) is found in the diet from plants, and is the FDA approved supplemental form of vitamin D. A small amount of 25-OHD is then metabolized in the kidney to 1,25-dihydroxyvitamin D, the active form of the hormone.
The physiological functions of Vitamin D include calcium homeostasis and bone mineralization, but it is also thought to play a role in protection against cancer, heart disease and type I diabetes; conditions that account for over 60% of deaths in the western world. Vitamin D insufficiency causes rickets, osteomalacia and hypertension and may also play a role in the development of multiple sclerosis, rheumatoid arthritis and asthma.
Historically, the most common method for measuring serum Vitamin D has been by immunoassay at reference laboratories, but there is significant intra- and inter-method variability in results. Our hospital laboratory and others have seen a dramatic rise in the request for Vitamin D testing, and it now appears that it may be more cost effective to carry out the assay in-house. To this end, we have developed an LC-MS/MS assay to measure Vitamin D. This presentation will provide the participants with information about methodologies for measurement of Vitamin D and discuss development of an LC-MS/MS assay that a clinical laboratory can implement.
Learning objectives: After attending this session, participants will be able to: 1) describe the clinical utility of determining a patient’s Vitamin D status, 2) explain the relevance of testing for the 25-OH vs the 1,25-OH form of Vitamin D, and 3) identify methods available for measuring Vitamin D in a clinical laboratory setting.
Peter Gilligan Ph.D.Director of the Clinical Microbiology-Immunology Laboratories, Professor of Microbiology-Immunology, UNC Hospitals
TBD
Bio- Dr Gilligan is Director of the Clinical Microbiology-Immunology Laboratories and University of North Carolina Hospitals, Director of the CPEP-approved postdoctoral training program in Medical and Public Health Microbiology, and Professor of Microbiology-Immunology and Pathology-Laboratory Medicine at the University of North Carolina School of Medicine. As a member of the Center for Infectious Diseases at UNC, he has participated in the development of improved diagnostic laboratory capacity in the developing world through his work with the UNC Project Diagnostic Laboratory Lilongwe, Malawi. He is a diplomate of the American Board of Medical Microbiology.
Dr Gilligan is currently an Editor for the Journal of Clinical Microbiology and Mbio as well as serving on the editorial board of three other clinical microbiology and infectious disease journals. As a Fellow of the
Dr Gilligan has published over 135 articles, monographs, book chapters, and books. He has given over 300 invited lectures and workshops. His research is focused on the microbiology of chronic lung infections in cystic fibrosis patients and the laboratory detection of emerging infectious disease agents.
Thomas Goodwin Ph.D.Project Scientist (NxPCM) and Director Disease Modeling & Tissue Analogues Laboratory, NASA
Bio-Engineered Regenerative Technology To Study Human Lung Viral Infections
Bio- Thomas J. Goodwin, PhD, serves as Project Scientist, Non Exercise Physiological Countermeasures (NxPCM) and Director, Disease Modeling & Tissue Analogues Laboratory NASA, Johnson Space Center, Houston, TX; Adjunct Professor, Department of Surgery, UT Galveston School of Medicine; and Adjunct Scientist, Southwest National Primate Research Center, San Antonio, TX. Dr. Goodwin is a leading expert in the seminal understanding of cell physiology and molecular genetics of ultra-low frequency pulsed electromagnetic field (PEMF) effects on human tissues. His research focuses on a developmental three-dimensional (3D) bioengineered model for human tissue organoids. Dr. Goodwin hold 18 U.S. patents, has published numerous scientific papers and is the recipient of over 50 NASA Scientific and Technical awards for his advanced tumor biology, infectious disease and regenerative tissue technologies. Historically, Dr. Goodwin’s research with Dr Lelund W.K. Chung, Emory University to study the effects of 3D prostate cancer cell growth in microgravity, was performed onboard the tragic STS-107 Columbia mission. This experiment, demonstrating golf ball-sized bio-engineered prostate tumors, was lost with the Columbia. However, videotape transmitted by Payload Commander Michael Anderson provided proof of this significant milestone in cancer biology.
Presentation Abstract- Acute respiratory infections, including pneumonia and influenza, are the 8th leading cause of death in the
Andrew Hoofnagle M.D. Ph.D.Director; Clinical Mass Spectrometry; Assistant Professor; Assistant Director; Clinical Chemistry, University of Washington
Quantifying Proteins in Clinical Samples Using LC-MS/MS
Bio- Dr. Hoofnagle is Assistant Professor of Laboratory Medicine and Director of Clinical Mass Spectrometry at the University of Washington Medical Center in
Presentation Abstract- Immunoassays are the cornerstone of protein quantification in the clinical laboratory and have been for decades. Unfortunately, immunoassays of proteins in human samples can be misleading for a significant number of patients and this can cause harm. In addition, immunoassays are difficult to harmonize across platforms and are not easily multiplexed. Liquid chromatography-tandem mass spectrometry has the potential to solve many of these problems. Different approaches to quantifying proteins in plasma or serum by LC-MS/MS will be presented.
Brad Karon M.D., Ph.D., FCAP, FACBMedical Director of CLS Program, Vice Chair of Education in the Department of Laboratory Medicine, Mayo Clinic
Patient Safety and Tight Glycemic Control: Determining accuracy requirements for glucose meters
Bio- Brad S. Karon MD PhD is director of point-of-care testing and Hospital Clinical Laboratories at Mayo Clinic in Rochester, MN. He is an Associate Professor of Laboratory Medicine and Pathology at Mayo Clinic. Dr Karon’s interests include critical and point-of-care testing in general; and specifically glucose meter accuracy and performance in the ICU. He is currently chair of the American Association for Clinical Chemistry (AACC) Critical and Point of Care Testing division and is a member of the College of American Pathologists Point of Care Testing resource committee.
Presentation Abstract- Glycemic control continues to be a controversial subject in laboratory medicine. The net benefit and harm from intravenous insulin administration, the ideal glucose target range for critically ill patients, and the glucose meter analytical performance criteria required for safe and effective management of patients on tight glycemic control (TGC) are not well understood. In this session I will review define the potential benefits of glycemic control in critically ill patients, weigh the benefits of glycemic control vs. the adverse effects of hypoglycemia, and list various proposes and established guidelines for glucose meter accuracy. I will also provide data from a novel simulation modeling approach to relate glucose meter performance characteristics to insulin dosing errors during TGC.
Elisabeth MaurerClinical Associate Professor, Pathology and Laboratory Medicine, Scientist, R&D Canadian Blood S, University of British Columbia - Centre for Blood Research
ThromboLUX – The first point-of-care platelet quality test
Bio- Dr. Elisabeth Maurer is the principal inventor of ThromboLUX and the founder of LightIntegra Technology. She now holds the positions of CTO & President at the company. Dr. Maurer has twenty years of research experience devoting her career to understanding platelet function and the application of dynamic light scattering. She is an adjunct scientist with Canadian Blood Services, holds a position as clinical associate professor with the University of British Columbia and is an active member of a number of organizations with a focus on blood transfusion. She received her Ph.D. in Physical Chemistry from the Karl-Franzens University in Graz, Austria.
Presentation Abstract- In North America, every year 4.2 million platelet transfusions are a life-saving part of cancer therapy and the treatment of bleeding patients. However, 1 in 6 or 17% of all platelet transfusions are ineffective. Currently no in vitro test is routinely used to identify ineffective platelet transfusions and distinguish them from effective ones. Instead, platelets are transfused without pre-transfusion quality test. The outcome in the patient is the only indicator of platelet effectiveness. To hospitals this is a very time consuming and costly practice; to patients ineffective platelet transfusions mean significantly increased risk of adverse reactions and resistance to subsequent platelet transfusions.
Previous attempts to develop a clinically relevant platelet quality test have failed. It is therefore unknown why some platelet transfusions work and others do not. In this presentation a new optical technology called ThromboLUX will be introduced. ThromboLUX is being developed in Vancouver to provide a safe, quick and simple diagnostic test for platelet quality and function. ThromboLUX has the potential to solve several problems in transfusion medicine: avoid the transfusion of ineffective platelets, test donors to identify the best platelet donors, and provide a quality control test that could allow the extension of the short 5-day shelf life and therefore reduce the outdate discard rate.
The ThromboLUX uses dynamic light scattering to determine the number and size of particles in suspension, which in case of platelet transfusions are primarily platelets and microparticles. The device also subjects the sample to a temperature cycle. Platelets are very temperature sensitive so that their response to the temperature change reveals whether the platelets are functional. The testing takes approximately 15 min. When the automated test is complete, the instrument compiles all the data and calculates and displays the quality score on a scale of 0 - 40.
The ThromboLUX was compared to other in vitro platelet tests and was evaluated in a clinical pilot study. The pilot study showed that a ThromboLUX score of 12 or lower on a scale of 0 – 40 is highly predictive of poor transfusion outcome in patients with blood cancer. Previous results, ongoing development and future plans will be presented.
Supervisory Health Scientist, US Centers for Disease Control and Prevention (CDC)
Clinical Performance of Laboratory Tests
Bio- Dr Shahangian has been a supervisory health scientist at the Division of Laboratory Science and Standards at CDC in Atlanta since 1993. In this capacity, he has worked on the evaluation of various quality determinants of clinical laboratory practice and development of laboratory recommendations and guidelines. He has been the senior author of more than 40 articles in peer–reviewed laboratory journals; and has also published in several other media and made numerous research / didactic presentations at various conference and institutional settings. He has been an active member of the American Association for Clinical Chemistry (since 1982) and is currently a diplomat of the American Board of Clinical Chemistry (since 1993) and a fellow of the National Academy of Clinical Biochemistry (since 1994). Prior to joining CDC, Shahram served as a technical director, senior scientist and also consultant (in 1989–1993) to several immunodiagnostic firms and research institutes (including Beckman–Coulter, Behring Diagnostics and Scripps Clinic & Research Foundation). He was on the research faculty of the University of Texas MD Anderson Cancer Center in 1985–1989 and completed a postdoctoral training program in clinical chemistry at the University of Utah during 1982–1984. After receiving a BS in chemistry with honors and highest distinction from the University of Illinois, Chicago, he started graduate work at the University of Illinois at Urbana–Champaign, receiving MS and PhD degrees in biochemistry (1979 and 1982, respectively).
Presentations Abstract- This presentation will address various issues relating to clinical performance of laboratory tests in diagnostic and screening contexts. Basic concepts related to laboratory test performance and clinical validation will be presented including: disease heterogeneity, classification / test referral bias, likelihood ratio and pre– / post–test odds ratios, predictive values and their relation to disease prevalence, and selection of best combination test strategies. Discussion will focus on (1) increasing clinical sensitivity or clinical specificity and (2) decreasing testing costs. Furthermore, evaluation of the clinical utility of laboratory tests will be considered with regard to clinical effectiveness, limitations, and methodological biases.
Sihe Wang Ph.D. DABCC FACBSection Head and Medical Director of the Clinical Biochemistry at Cleveland Clinic, Cleveland Clinic
Autoverification of clinical chemistry results
Bio- Sihe Wang graduated with a PhD from the University of North Carolina at Chapel Hill. After completing the Clinical Chemistry Fellowship Training Program accredited by the Commission on Accreditation in Clinical Chemistry (ComACC) at Duke University Medical Center, Dr. Wang joined Northwestern University as Assistant Professor. He then assumed the position of Director of Clinical Chemistry at Children’s Memorial Hospital, an affiliated pediatric hospital with Northwestern University. Dr. Wang is currently the Section Head and Medical Director of the Clinical Biochemistry at Cleveland Clinic. The Clinical Biochemistry Section runs ~5 million order-able tests/panels annually serving all aspects of clinical specialties including a pediatric hospital. Dr. Wang is also a medical staff at the Department of Nephrology and Hypertension. Dr. Wang established and has been the director of the ComACC accredited Clinical Biochemistry Fellowship Program at Cleveland Clinic. He is a clinical professor at the Department of Chemistry of Cleveland State University. Dr. Wang is a diplomat of the American Board of Clinical Chemistry and a fellow of National Academy of Clinical Biochemistry. He is also active in clinical and translational research. He has authored or co-authored over 70 peer-reviewed publications, book chapters, and abstracts. He has also lectured in the US and around the world on variety of clinical chemistry topics. Dr. Wang was the recipient of a few awards including the 2006 Lemuel J. Bowie Young Investigator Award at the Chicago Section of the American Association of Clinical Chemistry (AACC). He has served in many capacities in the AACC organizations including the chair of AACC Northeast Ohio Section in 2008 and 2009 and the president of North American Chinese Clinical Chemistry Association 2008-2009. Dr. Wang currently serves as the secretary for the Pediatric and Maternal Fetal Division of AACC.
Presentation Abstract- Target Audience: Pathologists, laboratory directors, administrators, supervisors, and medical technologists.
Abstract: Patient safety has become the focus of the national medical community since the publication of To Error Is Human by the
Learning Objectives: The participants will understand the basic concept of autoverification, the installation process, and value of service improvement as well as improved time management of the medical technologists.
Peter W.F. WilsonProfessor of Medicine & Public Health, Emory University School of Medicine & Rollins School of Public Health
TBD
Bio- Peter W. F. Wilson, MD is Professor of Medicine in the Division of Cardiology at Emory University School of Medicine and Professor of Public Health (Global Health, Epidemiology) in the Rollins School of Public Health at Emory University, where he is Director of Epidemiology and Genomic Medicine at the Atlanta VA Medical Center. He graduated with a B.S. from Yale University in 1970 and a medical degree from the University of Texas Medical School at San Antonio in 1974. His postgraduate medical training took place at Duke University and he is board certified in internal medicine and endocrinology. He was previously employed by the National Heart, Lung, and Blood Institute (1978-1999), Director of Laboratories at the Framingham Heart Study (1983-2003), Professor of Medicine at the Boston University School of Medicine (1999-2003) and Professor of Medicine at the Medical University of South Carolina (2003-2006). His research focuses on metabolic and cardiovascular disease in populations. He is an author or coauthor of more than 500 scientific articles and four books.
Gyorgy Abel M.D. Ph.D.Director; Clinical Immunology and Molecular Diagnostics;Clinical Chemistry Department of Laboratory, Harvard Medical School
TBD
Alex Rai Ph.D.Director; Specialty Laboratory; Chief Scientific Officer; Center for Advanced Laboratory Medicine, Columbia University
TBD
