Multicenter evaluation of the Selux Next-Generation Phenotyping antimicrobial susceptibility testing system.

antimicrobial susceptibility testing clinical diagnostics clinical microbiology

Journal

Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564

Informations de publication

Date de publication:
05 Dec 2023
Historique:
medline: 5 12 2023
pubmed: 5 12 2023
entrez: 5 12 2023
Statut: aheadofprint

Résumé

The Selux Next-Generation Phenotyping (NGP) system (Charlestown, MA) is a new antimicrobial susceptibility testing system that utilizes two sequential assays performed on all wells of doubling dilution series to determine MICs. A multicenter evaluation of the performance of the Selux NGP system compared with reference broth microdilution was conducted following FDA recommendations and using FDA-defined breakpoints. A total of 2,488 clinical and challenge isolates were included; gram-negative isolates were tested against 24 antimicrobials, and gram-positive isolates were tested against 15 antimicrobials. Data is provided for all organism-antimicrobial combinations evaluated, including those that did and did not meet FDA performance requirements. Overall very major error and major error rates were less than 1% (31/3,805 and 107/15,606, respectively), essential agreement and categorical agreement were >95%, reproducibility was ≥95%, and the average time-to-result (from time of assay start to time of MIC result) was 5.65 hours.

Identifiants

pubmed: 38051069
doi: 10.1128/jcm.00546-23
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0054623

Auteurs

Kristin R Baker (KR)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Kelly Flentie (K)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Benjamin R Spears (BR)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Sergey Mozharov (S)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Kristen Roberts (K)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Asmae El Ganbour (A)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Mark Somers (M)

Selux Diagnostics, Charlestown, Massachusetts, USA.

John Calkwood (J)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Jamie Liu (J)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Kayla DaPonte (K)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Nikitha Sam (N)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Gurleen Kaur (G)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Felicia Chen (F)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Jonathan Donato (J)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Alan Chao (A)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Autumn Lewis (A)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Jingzi Sherman (J)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Karen Mortimer (K)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Amanda T Harrington (AT)

Pathology and Laboratory Medicine, Loyola University Medical Center, Maywood, Illinois, USA.

Maria Traczewski (M)

Clinical Microbiology Institute (CMI), Wilsonville, Oregon, USA.

Darcie Carpenter (D)

IHMA, Schaumburg, Illinois, USA.

Dee Shortridge (D)

JMI Laboratories/Element, North Liberty, Iowa, USA.

Jill Lindley (J)

JMI Laboratories/Element, North Liberty, Iowa, USA.

Alexander Diep (A)

Element, Acton, Massachusetts, USA.

Emmet Norton (E)

Element, Acton, Massachusetts, USA.

Matt Green (M)

Element, Acton, Massachusetts, USA.

Joe Gajewski (J)

Element, Acton, Massachusetts, USA.

Rebecca Landrith (R)

Element, Acton, Massachusetts, USA.

Fatuma Nalubega (F)

Element, Acton, Massachusetts, USA.

Justin McCallum (J)

Boston Analytical, Salem, New Hampshire, USA.

Melissa Beiswenger (M)

Boston Analytical, Salem, New Hampshire, USA.

Brittany Dolan (B)

Boston Analytical, Salem, New Hampshire, USA.

Kathleen Brennan (K)

Boston Analytical, Salem, New Hampshire, USA.

Afton Carpenter (A)

Boston Analytical, Salem, New Hampshire, USA.

Aleksandar Vacic (A)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Alec N Flyer (AN)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Virginia M Pierce (VM)

Pathology, University of Michigan Medical School, Ann Arbor, Michigan, USA.

David C Hooper (DC)

Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

James S Lewis Ii (JS)

Department of Pharmacy Services, Oregon Health and Science University Hospitals and Clinics, Portland, Oregon, USA.

Eric Stern (E)

Selux Diagnostics, Charlestown, Massachusetts, USA.

Classifications MeSH