关键词: BioFire Neisseria meningitidis Streptococcus pneumoniae encephalitis enterovirus film array herpes simplex virus lab utilization

Mesh : Child Child, Preschool Diagnostic Equipment / economics statistics & numerical data Encephalitis / diagnosis virology Humans Meningitis / diagnosis microbiology Molecular Diagnostic Techniques / economics instrumentation methods statistics & numerical data Multiplex Polymerase Chain Reaction / instrumentation methods statistics & numerical data Neisseria meningitidis / genetics isolation & purification Simplexvirus / genetics isolation & purification Streptococcus pneumoniae / isolation & purification Syndrome United States United States Food and Drug Administration

来  源:   DOI:10.1128/JCM.00018-18   PDF(Sci-hub)

Abstract:
INTRODUCTIONSyndromic panels were first FDA cleared for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA, and most recently, the FilmArray meningitis/encephalitis panel (BioFire, Salt Lake City, UT) has become available. This assay detects 14 targets within 1 h and includes pathogens that typically cause different manifestations of infection, although they infect the same organ system. Several studies have reported both false-positive and false-negative results with this test, and all agree that the cost is significant. As with other panels, health care systems have adopted different strategies for offering this assay. Some have implemented strategies to limit the use of the test to certain patient populations, others have elected not to offer the test, and others have elected not to offer the test and instead request that providers order specific PCRs for the pathogens that best fit the patient\'s symptoms. In this Point-Counterpoint, Jennifer Dien Bard of the Department of Pathology and Laboratory Medicine, Children\'s Hospital Los Angeles, and of the Keck School of Medicine at the University of Southern California explains why laboratories should offer these assays without restriction. Kevin Alby of the University of Pennsylvania explains the concerns about the use of these assays as first-line tests and why some limitations on their use might be appropriate.
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