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Low Resource Can Be High Quality Global healthcare, from page 1 Organizing Committee, since she volunteered in Eritrea in 2006. She worked with a group of volunteers called Pathologists Overseas, who conduct training and help arrange for supplies and equipment to improve pathology and diagnostic services in developing countries. “I taught the medical students in their new medical school, and it really opened my eyes about global healthcare,” Gronowski said. “We don’t think about global healthcare, or everybody else’s health, on an everyday basis. We focus on our own little world. But to think that the health of people all around the world doesn’t affect us is like putting your head in the sand.” Gronowski is an Associate Professor of Pathology and Immunology, Obstetrics and Gynecology at Washington University School of Medicine in St. Louis. Gronowski spearheaded the effort to bring global health to the forefront of the educational program this year, starting with the opening plenary by Roy Vagelos, MD, former CEO of Merck & Co., who played a key role in providing free drugs to treat river blindness in developing countries. Then on Tuesday morning, Mark Perkins, PhD, chief scientific officer of the Foundation for Innovative New Diagnostics (FIND) will delve into the technical needs for IVDs in developing countries. Later, a full-day symposium, “Challenges in Global Infectious Diseases,” will tackle emerging global health issues and what strategies governments and NGOs are using to build up laboratories in low-resource settings. Smaller is Better With funding from the Bill & Melinda Gates Foundation, Yager’s lab is leading a collaboration with the Stayton lab at the University of Washington, PATH, Nanogen, and Micronics to develop a POC diagnostic platform for low-resource settings that can diagnose a wide range of diseases using parallel, nucleic acid-based assays, and immunoassays. The instrument, with an internal working name of the DxBox, features a compact, portable, shoe box-size reader, as well as disposable “lab cards” that use microfluidic circuits to perform up to six different tests from a few drops of blood. Importantly, all of the necessary reagents and buffers will be in a form that allows the cards to be stored for up to a year at ambient temperatures, and all sample cleanup and metering takes place within the card. “A capability that could not possibly have been extended to the developing world because of limitations of power, cost, reagent delivery, reagent storage, cold chain limitations, and transportation limitations—these things are now possible,” said Yager. “We can really extend some of our most sophisticated mechanisms of diagnosing disease to the remote ends of the diagnostic world. It’s not like we have to send the developing world our lowest quality, mediocre test— we can actually send them some of the best tests. That’s pretty exciting, particularly on the nucleic acid side.” The initial panel of tests on the cards will diagnose rapid-onset fevers, such as malaria, dengue, measles, Rickettsia, and Salmonella. The DxBox tackles many of the problems inherent to low-resource testing: lack 46 CliniCal laboratory news June 2008 of reliable power, harsh environments, and a dearth of trained personnel available to draw blood, perform testing, or maintain equipment. “Having been to Africa myself, you realize they have way different needs than we do,” said Gronowski. “Both their instruments and their reagents are frequently exposed to huge fluctuations in temperature, or must endure a really sandy environment, or fluctuations in power supply—just extreme conditions. Also maintenance: when things break down in Eritrea, it’s days and days for a person they have in Africa to get there. So these have to be reliable instruments, and they have to be very easy to use. Moreover, quality control is often times not well understood, so these need to be very stable instruments that are very forgiving.” David Kelso, PhD, Associate Professor of Biomedical Engineering at Northwestern University, will moderate this afternoon’s “Diagnostics for the Developing World” session. He also stresses the need for simplicity. “The simpler you make the device, the more complexity that is in it. It’s either chemical complexity, or computer complexity, or mechanical complexity. You have to do something to make it simple to use,” said Kelso. “So a lot of times, that requires getting into new technologies that have never been applied to diagnostics in the developing world. You really have to push the technology a lot further in these settings than you do for the developed world.” Current rapid tests used in lowresource settings include lateral flow strips or immunochromatographic strips that are generally qualitative, can be stored for long periods of time, and are relatively inexpensive. However, these strips have not lived up to expectations, mainly due to user error. “What people have found is that the performance of those tests is often not as good in developing world circumstances as they are back in the labs,” said Yager. “So one of the things we’re attempting to do is minimize the amount of user intervention required, so that user variability is no longer a factor, and environmental variability is not as much of a factor as it would be otherwise.” A Spectrum of Needs Kelso also emphasized another factor in low-resource diagnostics: understanding the unique needs of each country or setting. “Really understanding what the customer requirements are is the top challenge in developing low-resource diagnostics, in the very broadest sense,” said Kelso. “We think a point-of-care test, taking it right out to primary care, would be the best solution. But you go out to those primary care developed by a collaboration of paul yager’s and patrick stayton’s labs at the university of Washington, along with paTh, nanogen, and Micronics, this shoe box-sized platform, called the dxbox, employs advanced microfluidic technology to offer reliable and low-cost testing for a wide range of diseases. The system uses credit-card sized, disposable ‘lab cards’ that perform up to six tests from a small patient sample for pocT in low-resource settings. sites, and a lot of times there isn’t somebody there that is certified to draw blood. So then you follow the patient to when they get tested, and it’s at a district hospital, and that’s not where we envisioned the test. So we’re trying to understand the structure of how care is delivered and what resources are in what locations.” Yager’s focus is on delivering POC tests in low-resource settings that can be used by anybody. “Clearly there is a range of circumstances in the developing world. The cities often have nicely equipped hospitals and laboratories with power and most everything else they need, but the issues you have tend to mostly be in remote areas, where you don’t have continuous power, where you may not have air conditioning, and where you probably don’t have highly-trained technicians and can’t get supplies in on a regular basis.” However, Yager noted that instruments such as the DxBox can attend to needs across the spectrum. “The particular things that people want depends on the particular end user. Some of the people in the more sophisticated hospitals want quantitative results; the people in the lowest socioeconomic levels generally are looking at the quick and qualitative answer, like ‘Is it malaria or isn’t it?’ Not ‘How much malaria?’—just ‘Which drug do I use to treat the patient as quickly as possible before they go home?’ Turnaround is a very big deal in all these locations.” Coming Soon to a Clinic Near You? Although the DxBox and other POC instruments being developed for low-resource settings aim mainly to overcome environmental, economic, and personnel problems much different from those in U.S. labs, Kelso and others stress that these cutting-edge technologies will likely become very useful in developed countries in the near future as our healthcare system changes and evolves. “One trend that’s obvious is these clinics that are starting to appear in Wal-Mart and all kinds of alternative sites,” said Kelso. “They are, in my mind, a lot like the walk-in clinics over in Africa. It’s not low-resource, but it’s a situation where it’s incredibly important to get the results of your diagnostic test while the patient is right there. There are lots of situations where having a rapid, point-of-care test improves the ability of the physician to treat the patient.” Other potential uses of speedy and inexpensive low-resource methods include non-traditional healthcare settings like natural disasters, suggested Kelso, such as after a hurricane, when the usual laboratory infrastructure is wiped out. Mobile clinics or storefront clinics in impoverished areas could use them as well. Yager also put forward that hospitals might want something like his DxBox in certain circumstances. “Being able to have a rapid, nucleic acidbased test that can be done at the point-ofcare is really a critical capability. And if you do that, you don’t want the instrument to be incredibly expensive, because hospitals can’t afford to put in a large number of extremely expensive instruments that duplicate capabilities in the centralized lab. So the development of these technologies for point-of-care use in the developing world enables the cost to be driven down far enough that you can bring the technology back to sites in the developed world.” Low-resource-type diagnostics might also someday become routine in developed countries who increasingly are seeking ways to care for poor and uninsured citizens. “Eventually our healthcare system is going to evolve to take care of the 40 million poorest people, and they’re probably not going to be cared for in the same way that the richest 40 million are cared for,” noted Kelso. “So those clinics, those healthcare delivery systems are going to be different and will have functional aspects of the way South Africans or Ugandans take care of their population.” Shifting to a Global Health Perspective Although global healthcare doesn’t always mean low-resource healthcare, it does represent a different world view when it comes to laboratory medicine. “I would challenge people to think about more than just themselves in what they perceive as their immediate patient base,” said Gronowski. “We in healthcare have to take responsibility for the health of the world. In the long run, I believe it will affect the people in your small circle. If the health of people worldwide is good, then I don’t have to worry about Ebola virus, and bird flu, and SARS. I think we have to be knowledgeable about global health so that we can perhaps help others, but then ultimately down the road, to help ourselves as well.” cln
industry Workshops, continued from p. 6 Wednesday, july 30 7:00 a.m.–8:30 a.m. DENKA SEIKEN Co., Ltd. Small, Dense LDL Cholesterol and Heart Disease Prediction: Results from Framingham Speaker: Ernst J. Schaefer, MD, Professor and Senior Scientist, Tufts University School of Medicine Grand Hyatt Washington, Independence B Diagnostic Consulting Network Application of Fluorescence in Next Generation Lateral Flow Assays Speakers: Brendan O’Farrell, PhD, President, Diagnostic Consulting Network Jeff Bauer, Executive Vice President, R&D, Diagnostic Consulting Network Renaissance Hotel, Meeting Room 12, 13 Roche Prepare for the Changes in Hepatitis C Speakers: Brigitte Fernandes-McAlear, MBA, Group Marketing Manager, Roche Diagnostics Corporation Bryan Cobb, PhD, FACMG, Manager Clinical and Scientific Affairs, Roche Diagnostics Corporation Steve Rossi, PharmD, Roche Molecular Diagnostics Renaissance Hotel, Meeting Room 16 Roche/OraSure The Value of Oral Fluid Testing Speakers: Edward J. Cone, PhD, Penney Associates, Scientific Advisor R. Sam Niedbala, PhD, Lehigh University, Professor, Department of Chemistry Grand Hyatt Washington, Constitution B Roche Vitamin D 101: Clinical Utility of Monitoring Vitamin D3 in the General Public Speakers: Robert P. Heaney, MD, FACP, FACN, John A. Creighton University, Professor of Medicine, Department of Medicine. TBD Grand Hyatt Washington, Constitution A Roche Maximizing the Effectiveness of Your Intraoperative PTH program: Interpreting the New NACB Guidelines—The Lab and the Surgeon Perspective Speakers: Lori J. Sokoll, PhD, FASB, John Hopkins Medical Institutions, Associate Director of Clinical Chemistry, Department of Pathology Robert Udelsman, MD, MBA, FACS, William H. Carmalt Professor of Surgery, Chairman of Surgery, Chief, Surgery, Yale-New Haven Hospital Grand Hyatt Washington, Constitution D, E Sebia Electrophoresis The Diagnosis of Hemoglobinopathies and Thalassemias Utilizing Capillary Zone Electrophoresis Technology: Case Studies and Comparisons to Traditional Methodologies Speakers: Edward Wong, MD, Director of Hematology, Associate Director of Transfusion Medicine, Children’s Nation Medical Center Aigars Brants, PhD, Scientific Affairs Manager, Sebia Electrophoresis Grand Hyatt Washington, Farragut Square Siemens Healthcare Diagnostics High Sensitivity Troponin—Delivering Value for Chest Pain Management Speaker: Theresa Spence, Siemens Healthcare Diagnostics Grand Hyatt Washington, Independence F Siemens Healthcare Diagnostics Trends in Immunosuppressive Drug Use and Cost-Effective Monitoring of Immunosuppressive Drugs at the Local Community Level Speaker: Kelli Ryzewski, Siemens Healthcare Diagnostics Grand Hyatt Washington, Independence H Sysmex America, Inc. Sysmex XT-V Multi-Species Hematology Analyzer Speakers: Andrew R. Hay, Senior Director, Health System Sales, Sysmex America, Inc. Susan A. Vuylsteke, MD, Account Executive, Comparative Hematology, Sysmex America, Renaissance Hotel, Congressional Hall A Whatman, Inc. Blood Separation for Rapid Diagnostics: Principles, Materials, and Practice Speaker: Vincent A. Sy, Whatman, Inc., Technical Marketing, Manager Grand Hyatt Washington, Constitution C 6:00 p.m.–7:30 p.m. Applied Biosystems Advances in the use of LC/MS/MS for Toxicology Analysis Speakers: TBD Grand Hyatt Washington, Independence G, H, I Dawning Technologies, Inc. Advanced Applications of Dawning Middleware Speakers: John Selmyer, President, Dawning Technologies, Inc. Greg Schallert, Engineering Manager, Dawning Technologies, Inc. Grand Hyatt Washington, Constitution C & Corridor C Luminex Enhanced Detection of Respiratory Viruses Using the Luminex xTAG RVP Assay Speaker: Dr. Christine Ginocchio, Director of Microbiology and Molecular Diagnostics, Northshore Long Island Jewish Hospital Renaissance Hotel, Grand Ballroom East Ortho-Clinical Diagnostics, co-sponsored by bioMérieux and Roche Diagnostics Clarifying the Role of NT-proBNP by Consenus Speakers: TBD Renaissance Hotel, Grand Ballroom South Osmetech Molecular Diagnostics Latest Developments in the Pharmacogenetics of Warfarin Speaker: Michael D. Caldwell, MD, PhD, FACS, Marshfield Clinic Grand Hyatt Washington, Constitution B Randox Laboratories Ltd. Biochips Can Save Lives—Cardiovascular and Cerebrovascular Disease Speakers: Dr. Peter Fitzgerald, Managing Director, Randox Laboratories Ltd. John Lamont, Chief Scientific Officer, Randox Laboratories Ltd. Renaissance Hotel, Congressional Hall A Roche Scott and White HAI Control and Screening Program Speaker: Arundhati Rao, MD, Section Chief, Technical Pathology and Molecular Genetics, Scott and White Hospital Grand Hyatt Washington, Independence D, E Siemens Healthcare Diagnostics Non-Invasive Markers of Liver Fibrosis—Why Are They Needed? Speaker: Andrew Beard, Siemens Healthcare Diagnostics Renaissance Hotel, Ballroom West A Siemens Healthcare Diagnostics The A, B, and C’s of In Vitro Allergy Testing Speakers: TBD Renaissance Hotel, Ballroom West B Siemens Healthcare Diagnostics Trends in Infectious Disease Testing: A Conversion of Technologies to Meet the Emerging Threat Speakers: Katherine Soreng, Siemens Healthcare Diagnostics Grand Hyatt Washington, Independence B Thermo Fisher Scientific From Biomarker Discovery to Routine Assay-LCMS in Clinical Research Laboratories Speakers: Dr. Mary Lopez, Director, Biomarker Discovery Institute Dr. Ravinder Singh, Director, Endocrinology Laboratory, Mayo Clinic Dr. Donald Chace, Laboratory Director, Pediatric Medical Group Grand Hyatt Washington, Constitution D, E Third Wave Technologies Third Wave’s HPV Clinical Trial Results Speakers: TBD Renaissance Hotel, Grand Ballroom South As of May 14, 2008 index To adverTisers please thank these advertisers by telling them you saw their advertisement in Clinical Laboratory News. 3M Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 AutoGenomics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Chromsystems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 College of American Pathologists . . . . . . . . . . . . . . . . . . . . . . . 27 Fluid Metering (OEM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Gerresheimer Wilden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Hoover Precision Prods (OEM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Instrumentation Laboratory ............................. 40 Lifescan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Midland BioProducts (OEM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Mindray ................................................ 15 Olympus America ...................................24 & 25 Ortho-Clinical Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Proliant Health & Biologicals ............................. 34 Randox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Roche Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 & 5, 21, 29 Siemens Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Tosoh Bioscience ........................................ 31 Wheaton Science Pkg (OEM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 �� new Titles from aacc press Visit the AACC Bookstore to see the latest releases from AACC Press. dna from a to Z & back again Carol A. Holland and Daniel H. Farkas 2008, 191 pages, softcover ISBN 9781594250880 Product #5104 handbook of diagnostic endocrinology, second edition Edited by William E. Winter, Lori J. Sokoll, and Ishwarlal Jialal 2008, 447 pages, softcover ISBN 9781594250866 Product #5105 self-assessment in clinical laboratory science ii Edited by Alan H.B. Wu 2008, 382 pages, softcover ISBN 9781594250873 Product #5106 Quick Guide to clinical chemistry Q U I C K G U I D E T O Clinical Janelle M. Chiasera, Robert W. Chemistry Hardy, Janelle M. Chiasera Robert W. Hardy John A. Smith and John The Quick Guide to Clinical A. Chemistry Smith is a pocket-sized reference intended for physicians, nurses, physician assistants, nurse practitioners, medical technologists, pharmacists, and residents and students in those professions. This guide focuses on the selection and use of chemistry laboratory tests for diagnosing and managing emergent conditions such as poisonings, acute abdominal pain, and acute myocardial infarction. 2008, 92 pages, softcover The guide's small size allows it to be used in situations when quick decisions must be made regarding the ordering and interpretation of chemistry tests. The emergent clinical conditions and the associated laboratory tests are described together for quick reference. Although this Guide reviews several clinical conditions, it is not intended to be a comprehensive guide to all clinical ISBN 9781594250729 laboratory tests, nor is it intended to dictate what constitutes reasonable, appropriate, or best care in a given situation. Comprehensive references for such information currently exist. Instead, it should be seen as it is clearly named, a “Quick Guide” Product #4631 to clinical chemistry. HANDBOOK OF DIAGNOSTIC ENDOCRINOLOGY after the show—Two easy Ways to order Online: www.aacc.org Phone: Call AACC (1(800) 892-1400 and place your order directly with an AACC customer service representative. Have your credit card ready. coming soon… Applying Evidence-Based Laboratory Medicine: A Step-by-Step Guide Christopher P. Price and Robert H. Christenson Brain Biomarkers for Cerebral Ischemia: NMDA Neuroreceptors Degradation and Blood Assay Development, Svetlana Dambinova Handbook of Workplace Drug Testing, Second Edition edited by Jeri D. Ropero-Miller and Bruce A. Goldberger SECOND EDITION CliniCal laboratory news June 2008 47 EDITED BY WILLIAM E. WINTER, LORI J. SOKOLL, ISHWARLAL JIALAL, Q U I C K G U I D E T O ELECTROLYTES ASPARTATE AMINOTRANSFERASE ALANINE AMINOTRANSFERASE GAMMA-GLUTAMYL Clinical TRANSFERASE LIPASE GASTRINChemistry ACETAMINOPHEN CREATINE KINASE BRAIN NATRIURETIC PEPTIDE TROPONINS BLOOD UREA NITROGEN CREATININE OSMOLALITY CORTISOL BLOOD GASES GLUCOSE ANION GAP BILIRUBIN AMMONIA THERAPEUTIC DRUG MONITORING PHOSPHATIDYLGLYCEROL Janelle M. Chiasera FETAL FIBRONECTIN Robert W. Hardy John A. Smith THYROID STIMULATING HORMONE THYROID ANTIBODIES
Page 1 and 2: president ’s Welcome PreParing fo
Page 3 and 4: INDUSTRY WORKSHOPS Tuesday, july 29
Page 5 and 6: The American Association for Clinic
Page 7 and 8: AACC Awards, from page 10 Award for
Page 9 and 10: Divisions Recognize Contributions t
Page 11: CliniCal laboratory news Special ed

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