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
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