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

Patricia J. Simner*, Kimberlee A. Musser, Kara Mitchell, Mark G. Wise, Shawna Lewis, Rebecca Yee, Yehudit Bergman, Caryn E. Good, Ayman M. Abdelhamed, Henry Li, Erin M. Laseman, Dan Sahm, Kelsey Pitzer, Julia Quan, G. Terrance Walker, Michael R. Jacobs, Daniel D. Rhoads

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

The Acuitas antimicrobial resistance (AMR) gene panel is a qualitative, multiplex, nucleic acid-based in vitro 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 Enterobacterales, 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 armA, CTX-M-2, DHA, IMP, OXA-9, SHV, vanA, and VEB. The negative percent agreement (NPA) for the majority of targets was $99%, except for AAC, AAD, CMY-41, P. aeruginosa gyrA 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.

Original languageAmerican English
Article numbere02098-21
JournalJournal of Clinical Microbiology
Volume60
Issue number3
DOIs
StatePublished - Mar 2022
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2022 American Society for Microbiology. All Rights Reserved.

Keywords

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

Fingerprint

Dive into the research topics of 'Multicenter Evaluation of the Acuitas AMR Gene Panel for Detection of an Extended Panel of Antimicrobial Resistance Genes among Bacterial Isolates'. Together they form a unique fingerprint.

Cite this