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

Area of Science:

• Clinical microbiology
• Infectious diseases
• Diagnostic technology

Background:

• Antimicrobial resistance necessitates accurate and efficient susceptibility testing.
• Traditional methods like broth microdilution can be time-consuming.
• The Selux Next-Generation Phenotyping (NGP) system introduces a novel approach to MIC determination.

Purpose of the Study:

• To evaluate the performance of the Selux NGP system.
• To compare the NGP system against the reference broth microdilution method.
• To assess performance based on FDA recommendations and breakpoints.

Main Methods:

• A multicenter study involving 2,488 clinical and challenge isolates.
• Testing gram-negative isolates against 24 antimicrobials and gram-positive isolates against 15.
• Utilizing two sequential assays on doubling dilution series for MIC determination.

Main Results:

• Overall very major error rates <1% and major error rates <1%.
• Essential agreement and categorical agreement exceeded 95%.
• Reproducibility was ≥95% with an average time-to-result of 5.65 hours.

Conclusions:

• The Selux NGP system demonstrates high accuracy and efficiency in antimicrobial susceptibility testing.
• The system meets FDA performance requirements for most organism-antimicrobial combinations.
• NGP offers a promising advancement for rapid MIC determination in clinical settings.