Report Discusses POC Testing and Changing Paradigms

Technology for diagnosing infectious diseases in patients is rapidly advancing, and new diagnostic tests have the potential to meaningfully improve patient care. Recommendations for the Academy’s report (Changing Diagnostic Paradigms for Microbiology, published May 2017) were based on discussions of a panel of experts. The Academy convened a colloquium October 17-18, 2016, (Washington, DC; USA) to explore the development and implementation of near-patient and POC testing and to provide recommendations for using these tests to improve patient care across clinical settings.

“Rapid diagnostic tests have the potential to deliver timely results, enable treatment decisions by detecting the presence of biomarkers, distinguish between viral and bacterial infections, identify causative organisms, and provide information on drug resistance,” said Melissa Miller, PhD, steering committee chair of the colloquium. The report focuses on the unmet needs for research and development of new diagnostic tests, for ongoing regulatory review of POC tests, and for laboratorian expertise, even in near-patient settings. The participants also discussed the importance of proper interpretation of test results, and linking test results to electronic medical records. They emphasized the need for microbiology experts to guide the development and utilization of tests and ensure proper reporting of results.

“The expertise of clinical microbiologists is essential to maximizing the value and minimizing the risk of POC infectious disease diagnostics, provided that clinical microbiologists adapt their practice to this setting,” said Sheldon Campbell, MD, PhD, Yale School of Medicine, a participant in the colloquium.

The report summarized proper utilization of tests (such as ordering appropriate tests and correctly interpreting results), the need for proper training and education on test usage, and contamination concerns. It also discussed regulation of the tests (reporting issues to FDA, CMS requirements), and the importance of documenting results and reporting to health departments when necessary. For the future, participants agreed that POC tests should be linked to web-based quality and performance matrices that would revolutionize POC testing quality and reach.

A commentary with additional information on advances in diagnostics, Advances Afoot in Microbiology by Mayo Clinic’s Patel R and Karon BS, was published May 24, 2017, in the Journal of Clinical Microbiology.