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Evaluation of Piperacillin-Tazobactam Testing against Enterobacterales by the Phoenix, MicroScan, and Vitek2 Tests Using Updated Clinical and Laboratory Standards Institute Breakpoints.
Manuel, Carmila; Maynard, Richard; Abbott, April; Adams, Kara; Alby, Kevin; Sweeney, Amy; Dien Bard, Jennifer; Flores, Irvin Ibarra; Rekasius, Violet; Harrington, Amanda; Kidd, Tiffany S; Mathers, Amy J; Tekle, Tsigereda; Simner, Patricia J; Humphries, Romney M.
Afiliación
  • Manuel C; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Maynard R; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Abbott A; Laboratory Medicine, Microbiology and Molecular Diagnostics, Deaconess Health System, Evansville, Indiana, USA.
  • Adams K; Laboratory Medicine, Microbiology and Molecular Diagnostics, Deaconess Health System, Evansville, Indiana, USA.
  • Alby K; Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
  • Sweeney A; Clinical Microbiology Laboratory, McLendon Clinical Laboratories, UNC Medical Center, Chapel Hill, North Carolina, USA.
  • Dien Bard J; Clinical Microbiology Laboratory, McLendon Clinical Laboratories, UNC Medical Center, Chapel Hill, North Carolina, USA.
  • Flores II; Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  • Rekasius V; Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  • Harrington A; Department of Pathology and Laboratory Medicine, Loyola University, Chicago, Illinois, USA.
  • Kidd TS; Department of Pathology and Laboratory Medicine, Loyola University, Chicago, Illinois, USA.
  • Mathers AJ; Clinical Microbiology Laboratory, University of Virginia Medical Center, Charlottesville, Virginia, USA.
  • Tekle T; Clinical Microbiology Laboratory, University of Virginia Medical Center, Charlottesville, Virginia, USA.
  • Simner PJ; Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
  • Humphries RM; Department of Pathology, Division of Medical Microbiology, Johns Hopkins University, Baltimore, Maryland, USA.
J Clin Microbiol ; 61(2): e0161722, 2023 02 22.
Article en En | MEDLINE | ID: mdl-36719243
In 2022, the Clinical and Laboratory Standards Institute (CLSI) updated piperacillin-tazobactam (TZP) breakpoints for Enterobacterales, based on substantial data suggesting that historical breakpoints did not predict treatment outcomes for TZP. The U.S. Food and Drug Administration (FDA) has not yet adopted these breakpoints, meaning commercial manufacturers of antimicrobial susceptibility testing devices cannot obtain FDA clearance for the revised breakpoints. We evaluated the Phoenix (BD, Sparks, MD), MicroScan (Beckman Coulter, Sacramento, CA), and Vitek2 (bioMérieux, Durham, NC) TZP MICs compared to reference broth microdilution for a collection of 284 Enterobacterales isolates. Phoenix (n = 167 isolates) demonstrated 84.4% categorical agreement (CA), with 4.2% very major errors (VMEs) and 1.8% major errors (MEs) by CLSI breakpoints. In contrast, CA was 85.0% with 4.3% VMEs and 0.8% MEs for the Phoenix with FDA breakpoints. MicroScan (n = 55 isolates) demonstrated 80.0% CA, 36.4% VMEs, and 4.8% MEs by CLSI breakpoints and 81.8% CA, 44.4% VMEs, and 0.0% MEs by FDA breakpoints. Vitek2 (n = 62 isolates) demonstrated 95.2% CA, 6.3% VMEs, and 0.0% MEs by CLSI and 96.8% CA, 0.0% VMEs, and 2.2% MEs by FDA breakpoints. Overall, the performance of the test systems was not substantially different using CLSI breakpoints off-label than using on-label FDA breakpoints. However, limitations were noted with higher-than-desired VME rates (all three systems) and lower-than-desired CA (MicroScan and Phoenix). Laboratories should consider adoption of the revised CLSI breakpoints with automated test systems but be aware that some performance challenges exist for testing TZP on automated systems, regardless of breakpoints applied.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antibacterianos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Microbiol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antibacterianos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Microbiol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos