Changing Diagnostic Paradigms for Microbiology A report from the Changing Diagnostic Paradigms for Microbiology Report on an American Academy of Microbiology Colloquium held in Washington, DC, from 17 to 18 October 2016. Virginia Dolen, Rapporteur The American Academy of Microbiology (Academy) is the provide feedback, and every effort has been made to ensure that honorific branch of the American Society for Microbiology the information is accurate and complete. The contents reflect the (ASM), a nonprofit scientific society with nearly 48,000 members. views of the participants and are not intended to reflect official Fellows of the Academy have been elected by their peers in positions of the Academy or of ASM. recognition of their outstanding contributions to the microbial The Academy acknowledges Margaret Milhous for her assistance sciences. Through its colloquium program, the Academy draws in editing this report. In addition, the Academy thanks the efforts on the expertise of these fellows to address critical issues in the of Daniel Peniston for his assistance on this project. microbial sciences. Contents of the report may be distributed further so long as the This report is based on the deliberations of experts who gathered authorship of the Academy is acknowledged and this disclaimer for two full days to discuss a series of questions developed by language is included. the steering committee. All participants had the opportunity to BOARD OF GOVERNORS, AMERICAN ACADEMY OF MICROBIOLOGY Michele S. Swanson, Ph.D., Chair Nancy Craig, Ph.D. Steven Lindow, Ph.D. University of Michigan Medical School The Johns Hopkins University University of California, Berkeley Martin J. Blaser, M.D. School of Medicine Margaret McFall-Ngai, Ph.D. New York University School of Medicine Terence S. Dermody, M.D. Pacific Biosciences Research Center, Donald A. Bryant, Ph.D. Children’s Hospital of Pittsburgh University of Hawaii at Manoa Pennsylvania State University of UPMC Mary Ann Moran, Ph.D. Stanley Fields, Ph.D. Arturo Casadevall, M.D., Ph.D., Chair-Elect University of Georgia Johns Hopkins Bloomberg University of Washington Graham C. Walker, Ph.D. School of Public Health James M. Hughes, M.D. Massachusetts Institute of Technology Emory University School of Medicine Alice S. Weissfeld, Ph.D. Microbiology Specialists COLLOQUIUM STEERING COMMITTEE Melissa B. Miller, Ph.D., Chair Karen C. Carroll, M.D. Nathan A. Ledeboer, Ph.D. University of North Carolina Johns Hopkins University Medical College of Wisconsin at Chapel Hill School of Medicine Kenneth Bahk, Ph.D. Keith Klugman, M.D., Ph.D. Three Lakes Partners Bill & Melinda Gates Foundation PARTICIPANTS Edina Avdic, Pharm.D., M.B.A. Nancy E. Cornish, M.D. Jeanne Mumford, M.T. (ASCP) The Johns Hopkins Hospital Centers for Disease Control Johns Hopkins Medicine Tobias Barker, M.D. and Prevention Daniel D. Rhoads, M.D. CVS Health Scott Cunningham, M.S., M.T. (ASCP), S.M. Case Western Reserve University Steve Beuchaw, M.B.A. Mayo Clinic Kristian Roth, Ph.D. Morgan Stanley Charlotte A. Gaydos, M.S., M.P.H., Dr.P.H. Food and Drug Administration Carey-Ann Burnham, Ph.D. Johns Hopkins University Paul Schreckenberger, M.S., Ph.D. Washington University in St. Louis Alberto Gutierrez, Ph.D. Loyola University Chicago School of Medicine Food and Drug Administration Fred C. Tenover, Ph.D. Sheldon Campbell, M.D., Ph.D. Alexander J. McAdam, M.D., Ph.D. Cepheid Yale School of Medicine Boston Children’s Hospital Dan Wattendorf, M.D. Bill and Melinda Gates Foundation ACADEMY STAFF ASM LEADERSHIP Marina Moses, M.S., Dr.P.H. Isabel Hinestrosa Stefano Bertuzzi, Ph.D., M.P.H. Director Board of Governors Program Assistant Chief Executive Officer Virginia Dolen Daniel Peniston Program Manager Colloquium and Outreach Program Assistant Dedicated to the memory of Paul Schreckenberger. Copyright 2017 | American Academy of Microbiology | 1752 N Street, NW | Washington, DC 20036 | www.asm.org/academy Recommendations Implementation Oversight Evaluation • Redesign clinic workflows to • Maintain clinical microbiology • Conduct clinical outcomes incorporate near-patient and laboratory expertise and and cost-effectiveness studies point-of-care (POC) testing. oversight of infectious disease for near-patient and POC • Promote proper interpreta- tests. tests. tion of tests to avoid adverse • Utilize competent personnel • Evaluate near-patient and outcomes. to oversee ordering, testing, POC tests periodically and • Provide resources, such as and interpretation. undertake regulatory action training videos, to support • Educate providers and pa- or reclassification for tests appropriate self-collection tients on different types that do not meet perfor- of patient specimens. of tests. mance standards. • Ensure that public health surveillance of infectious diseases is maintained with POC testing. • Link near-patient and POC test results to the patient’s electronic medical record (EMR). Introduction Clinical microbiology laboratories offer specialized testing methods that require minimal designated expertise to perform diagnostic testing, such as space, turnaround times, physical resources, and culture and molecular detection of pathogens, for trained personnel to operate. Patient expectations, infectious indications (Buchan and Ledeboer 2014). advances in medical knowledge and technology, Currently, laboratories face increased pressures to and a desire for targeted treatment are driving perform more testing while reducing turnaround the increased availability of on-demand testing for times in the setting of high staff turnover and staff infectious diseases. shortages (Bourbeau and Ledeboer 2013). Cen- Low-complexity, rapid, and accurate diagnos- tralized laboratories may need to serve an increas- tic tests for infectious diseases performed on ing number of decentralized patients in a system demand closer to the point of patient care have or network affiliated with a hospital, which may the potential to deliver timely results to inform include a number of clinics located at a distance diagnosis and treatment. Near-patient and point- from the laboratory. At the same time, economic of-care (POC) testing increases access to efficient pressures push healthcare systems to demonstrate diagnostic testing across many settings; this field cost-effectiveness and high-value care. is rapidly advancing. Clinical Laboratory Improve- While diagnostic tests performed in a central ment Amendments (CLIA)-waived nucleic acid laboratory allow for specialized expertise and amplification tests (NAATs) can be performed high-complexity testing, they may not offer timely outside laboratories by nonlaboratorians while results for patient care. The central laboratory may producing results essentially equivalent to have limited hours of operation and may perform more-complex, gold standard laboratory assays. batch testing (versus on-demand testing) in order To explore the development and implementation to optimize use of resources. In addition, delivery of near-patient and POC tests, the American mechanisms are changing in healthcare. Some Academy of Microbiology (Academy) convened settings (such as rapid or convenient care clinics a colloquium of experts to discuss relevant issues or clinics in the developing world) do not have and needs and to provide recommendations. a dedicated microbiology laboratory and require A report from the American Academy of Microbiology | 1 Statement of Task The American Academy of Microbiology (Academy) convened a colloquium to examine the role of near-patient testing and its impact on the changing diagnostic paradigms for microbiology. Rapid diagnostic tests have the potential to deliver timely results to enable treatment decisions in both laboratory and nonlaboratory settings. Such tests could, for example, detect the presence of biomarkers, distinguish between viral and bacterial infections, identify causative organisms, determine strain type, or provide information on drug resistance. Automation, simplification, and miniaturization of diagnostic tests allow them to be performed outside clinical microbiology laboratories, such as in physicians’ offices, pharmacies, convenient care clinics, or even at home. Innovative developers and the financial community are working to leverage the latest technology to impact patient care, as the information gleaned from rapid diagnostics has the potential to inform individual treatment decisions as well as the public health response when outbreaks are rapidly identified. Expertise in the microbial sciences is needed to guide the development and utilization of new tests, as are oversight and proficiency testing to ensure that the tests are being conducted correctly and that results are reported to the appropriate parties. Additionally, it is crucial to maintain personnel with adequate clinical microbiology laboratory expertise to assist with decision support and perform advanced testing. This colloquium addressed the proliferation of near-patient testing and how diagnostic testing for infectious diseases may be distributed between centralized laboratories and POC locations. 2 | Changing Diagnostic Paradigms for Microbiology Approach to the Task microbiology, diagnostic and POC testing, phar- macy, medicine, laboratory medicine, public health, The Academy is the honorific leadership group informatics, device development, device regulation, within the American Society for Microbiology and investment. Colloquium participants were (ASM), the world’s oldest and largest life science assigned 11 main