title: Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial.
abstract: Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes (mecA, vanA/B, and blaKPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity and specificity of the panel with those of the laboratories' standard phenotypic identification techniques, as well as with molecular methods used to distinguish Acinetobacter baumannii from other members of the A. calcoaceticus-A. baumannii complex and to detect antimicrobial resistance genes. Testing included 2,207 positive aerobic blood culture samples, 1,568 clinical and 639 seeded. Samples were tested fresh or were frozen for later testing within 8 h after the bottles were flagged as positive by an automated blood culture system. At least one organism was detected by the panel in 1,382 (88.1%) of the positive clinical specimens. The others contained primarily off-panel organisms. The panel reported multiple organisms in 81 (5.86%) positive clinical specimens. The unresolved blood culture identification sensitivity for all target detections exceeded 96%, except for Klebsiella oxytoca (92.2%), which achieved 98.3% sensitivity after resolution of an unavoidable phenotypic error. The sensitivity and specificity for vanA/B and blaKPC were 100%; those for mecA were 98.4 and 98.3%, respectively.
authors.affiliation: Department of Pathology, Wayne State University School of Medicine, Detroit, Michigan, USA DMC University Laboratories, Detroit, Michigan, USA.
authors.forename: Hossein
authors.initials: H
authors.lastname: Salimnia
authors.affiliation: Department of Pathology, Wayne State University School of Medicine, Detroit, Michigan, USA DMC University Laboratories, Detroit, Michigan, USA mfairfax@dmc.org.
authors.forename: Marilynn R
authors.initials: MR
authors.lastname: Fairfax
authors.affiliation: DMC University Laboratories, Detroit, Michigan, USA.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Lephart
authors.affiliation: Loyola University Medical Center, Chicago, Illinois, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Schreckenberger
authors.affiliation: Loyola University Medical Center, Chicago, Illinois, USA.
authors.forename: Sharon M
authors.initials: SM
authors.lastname: DesJarlais
authors.affiliation: Department of Pathology, University of Maryland, Baltimore, Maryland, USA.
authors.forename: J Kristie
authors.initials: JK
authors.lastname: Johnson
authors.affiliation: Department of Pathology, University of Maryland, Baltimore, Maryland, USA.
authors.forename: Gwen
authors.initials: G
authors.lastname: Robinson
authors.affiliation: Division of Medical Microbiology, Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Karen C
authors.initials: KC
authors.lastname: Carroll
authors.affiliation: Division of Medical Microbiology, Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Greer
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Margie
authors.initials: M
authors.lastname: Morgan
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Chan
authors.affiliation: Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Loeffelholz
authors.affiliation: Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA.
authors.forename: Frances
authors.initials: F
authors.lastname: Valencia-Shelton
authors.affiliation: New York-Presbyterian Hospital, Weill-Cornell Medical Center, New York, New York, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jenkins
authors.affiliation: New York-Presbyterian Hospital, Weill-Cornell Medical Center, New York, New York, USA.
authors.forename: Audrey N
authors.initials: AN
authors.lastname: Schuetz
authors.affiliation: Department of Pathology, University of Utah, and Primary Children's Medical Center, Salt Lake City, Utah, USA.
authors.forename: Judy A
authors.initials: JA
authors.lastname: Daly
authors.affiliation: Department of Pathology, University of Utah, and Primary Children's Medical Center, Salt Lake City, Utah, USA.
authors.forename: Trenda
authors.initials: T
authors.lastname: Barney
authors.affiliation: BioFire Diagnostics LLC, Salt Lake City, Utah, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hemmert
authors.affiliation: BioFire Diagnostics LLC, Salt Lake City, Utah, USA.
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Kanack
mesh_terms: D001419:Bacteria / Q000145:classification* / Q000187:drug effects / Q000235:genetics*; D024881:Drug Resistance, Bacterial; D025141:Drug Resistance, Fungal; D005798:Genes, Bacterial; D005800:Genes, Fungal; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000175:diagnosis* / Q000382:microbiology*; D015003:Yeasts / Q000145:classification* / Q000187:drug effects / Q000235:genetics*