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Changing Diagnostic Paradigms for Microbiology

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Near-patient and POC testing for infectious disease diagnostics is rapidly evolving. CLIA-waived NAATs have performance characteristics similar to those of more-complex, gold standard laboratory assays. The impact that these new assays will have on patient outcomes, healthcare delivery models, public health, and healthcare costs is still not clear. The role that clinical microbiology laboratories will play in advanced POC tests for infectious diseases is changing. As near-patient and POC testing is increasingly implemented in new settings and by nonlaboratorians, clinical microbiology laboratory expertise is needed to ensure proper oversight of quality assurance, competency and proficiency testing. Integration of POC tests into electronic systems, along with automated quality monitoring, can greatly improve their contribution to diagnostic microbiology. Utilization of trained personnel and evaluation of tests will ensure that the best-quality tests are ordered and interpreted correctly to benefit patient care.

Executive Summary

Near-patient and POC testing for infectious disease diagnostics is rapidly evolving. CLIA-waived NAATs have performance characteristics similar to those of more-complex, gold standard laboratory assays. The impact that these new assays will have on patient outcomes, healthcare delivery models, public health, and healthcare costs is still not clear. The role that clinical microbiology laboratories will play in advanced POC tests for infectious diseases is changing. As near-patient and POC testing is increasingly implemented in new settings and by nonlaboratorians, clinical microbiology laboratory expertise is needed to ensure proper oversight of quality assurance, competency and proficiency testing. Integration of POC tests into electronic systems, along with automated quality monitoring, can greatly improve their contribution to diagnostic microbiology. Utilization of trained personnel and evaluation of tests will ensure that the best-quality tests are ordered and interpreted correctly to benefit patient care.

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