Multicenter Evaluation of the Acuitas AMR Gene Panel for Detection of an Extended Panel of Antimicrobial Resistance Genes among Bacterial Isolates

Authors

Patricia J. Simner, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kimberlee A. Musser, New York State Department of Health, Wadsworth Center, Albany, New York, USA.
Kara Mitchell, New York State Department of Health, Wadsworth Center, Albany, New York, USA.
Mark G. Wise, IHMA, Schaumburg, Illinois, USA.
Shawna Lewis, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Rebecca Yee, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Yehudit Bergman, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Caryn E. Good, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Ayman M. Abdelhamed, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Henry Li, IHMA, Schaumburg, Illinois, USA.
Erin M. Laseman, IHMA, Schaumburg, Illinois, USA.
Dan Sahm, IHMA, Schaumburg, Illinois, USA.
Kelsey Pitzer, OpGen, Inc., Rockville, Maryland, USA.
Julia Quan, OpGen, Inc., Rockville, Maryland, USA.
G Terrance Walker, OpGen, Inc., Rockville, Maryland, USA.
Michael R. Jacobs, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Daniel D. Rhoads, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.

Document Type

Journal Article

Publication Date

3-16-2022

Journal

Journal of clinical microbiology

Volume

60

Issue

3

DOI

10.1128/JCM.02098-21

Keywords

antimicrobial resistance; antimicrobial stewardship; bacterial isolates; diagnostics; infection control; molecular methods

Abstract

The Acuitas antimicrobial resistance (AMR) gene panel is a qualitative, multiplex, nucleic acid-based diagnostic test for the detection and differentiation of 28 antimicrobial resistance markers associated with not susceptible results (NS; i.e., intermediate or resistant) to one or more antimicrobial agents among cultured isolates of select , Pseudomonas aeruginosa, and Enterococcus faecalis. This study was conducted at four sites and included testing of 1,224 deidentified stocks created from 584 retrospectively collected isolates and 83 prospectively collected clinical isolates. The Acuitas results were compared with a combined reference standard including whole-genome sequencing, organism identification, and phenotypic antimicrobial susceptibility testing. The positive percent agreement (PPA) for FDA-cleared AMR targets ranged from 94.4% for MCR-1 to 100% for , CTX-M-2, DHA, IMP, OXA-9, SHV, , and VEB. The negative percent agreement (NPA) for the majority of targets was ≥99%, except for AAC, AAD, CMY-41, P. aeruginosa mutant, Sul1, Sul2, and TEM targets (range, 96.5% to 98.5%). Three AMR markers did not meet FDA inclusion criteria (GES, SPM, and MCR-2). For each organism, 1 to 22 AMR targets met the minimum reportable PPA/NPA and correlated with ≥80% positive predictive value with associated NS results for at least one agent (i.e., the probability of an organism carrying an AMR marker testing NS to the associated agent). We demonstrate that the Acuitas AMR gene panel is an accurate method to detect a broad array of AMR markers among cultured isolates. The AMR markers were further associated with expected NS results for specific agent-organism combinations.

APA Citation

Simner, Patricia J.; Musser, Kimberlee A.; Mitchell, Kara; Wise, Mark G.; Lewis, Shawna; Yee, Rebecca; Bergman, Yehudit; Good, Caryn E.; Abdelhamed, Ayman M.; Li, Henry; Laseman, Erin M.; Sahm, Dan; Pitzer, Kelsey; Quan, Julia; Walker, G Terrance; Jacobs, Michael R.; and Rhoads, Daniel D., "Multicenter Evaluation of the Acuitas AMR Gene Panel for Detection of an Extended Panel of Antimicrobial Resistance Genes among Bacterial Isolates" (2022). GW Authored Works. Paper 582.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/582

Department

Pathology