title: Analytical Performance of Multiplexed Screening Test for 10 Antibiotic Resistance Genes from Perianal Swab Samples.
abstract: BACKGROUND
  Multiantibiotic-resistant bacteria pose a threat to patients and place an economic burden on health care systems. Carbapenem-resistant bacilli and extended-spectrum β-lactamase (ESBL) producers drive the need to screen infected and colonized patients for patient management and infection control.
  
  
  METHODS
  We describe a multiplex microfluidic PCR test for perianal swab samples (Acuitas(®) MDRO Gene Test, OpGen) that detects the vancomycin-resistance gene vanA plus hundreds of gene subtypes from the carbapenemase and ESBL families Klebsiella pneumoniae carbapenemase (KPC), New Delhi metallo-β-lactamase (NDM), Verona integron-mediated metallo-β-lactamase (VIM), imipenemase metallo-β-lactamase (IMP), OXA-23, OXA-48, OXA-51, CTX-M-1, and CTX-M-2, regardless of the bacterial species harboring the antibiotic resistance.
  
  
  RESULTS
  Analytical test sensitivity per perianal swab is 11-250 CFU of bacteria harboring the antibiotic resistance genes. Test throughput is 182 samples per test run (1820 antibiotic resistance gene family results). We demonstrate reproducible test performance and 100% gene specificity for 265 clinical bacterial organisms harboring a variety of antibiotic resistance genes.
  
  
  CONCLUSIONS
  The Acuitas MDRO Gene Test is a sensitive, specific, and high-throughput test to screen colonized patients and diagnose infections for several antibiotic resistance genes directly from perianal swab samples, regardless of the bacterial species harboring the resistance genes.
authors.affiliation: OpGen, Gaithersburg, MD. twalker@opgen.com.
authors.forename: G Terrance
authors.initials: GT
authors.lastname: Walker
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Tony J
authors.initials: TJ
authors.lastname: Rockweiler
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Rossio K
authors.initials: RK
authors.lastname: Kersey
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Kelly L
authors.initials: KL
authors.lastname: Frye
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Susan R
authors.initials: SR
authors.lastname: Mitchner
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Toal
authors.affiliation: OpGen, Gaithersburg, MD.
authors.forename: Julia
authors.initials: J
authors.lastname: Quan
mesh_terms: D001003:Anal Canal / Q000382:microbiology*; D001426:Bacterial Proteins / Q000235:genetics; D019729:Carbon-Oxygen Ligases / Q000235:genetics; D024881:Drug Resistance, Bacterial / Q000235:genetics*; D005798:Genes, Bacterial; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D001618:beta-Lactamases / Q000235:genetics
chemical_list: D001426:Bacterial Proteins; C071437:VanA ligase, Bacteria; C071167:beta-lactamase CTX-2; C466679:beta-lactamase OXA-23; C055184:beta-lactamase TEM-3; D001618:beta-Lactamases; C531581:carbapenemase-2, Klebsiella pneumoniae; C108449:oxacillinase; D019729:Carbon-Oxygen Ligases