Journal of clinical microbiology
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J. Clin. Microbiol. · May 2018
Review Historical ArticleImpact of 21st Century Cures Act on Breakpoints and Commercial Antimicrobial Susceptibility Test Systems: Progress and Pitfalls.
Antimicrobial resistance is the most pressing medical challenge of the past decade. At the front line are clinical laboratories, which are responsible for accurately reporting antimicrobial susceptibility test (AST) results to clinicians and public health authorities. ⋯ We describe the pathway and history of U. S. regulation of cASTs and outline both the rewards and unmet needs possible from the 21st Century Cures Act.