title: Multicenter evaluation of the Staphylococcus QuickFISH method for simultaneous identification of Staphylococcus aureus and coagulase-negative staphylococci directly from blood culture bottles in less than 30 minutes.
abstract: A novel rapid peptide nucleic acid fluorescence in situ hybridization (FISH) method, Staphylococcus QuickFISH, for the direct detection of Staphylococcus species from positive blood culture bottles was evaluated in a multicenter clinical study. The method utilizes a microscope slide with predeposited positive- and negative-control organisms and a self-reporting 15-min hybridization step, which eliminates the need for a wash step. Five clinical laboratories tested 722 positive blood culture bottles containing gram-positive cocci in clusters. The sensitivities for detection of Staphylococcus aureus and coagulase-negative staphylococci (CoNS) were 99.5% (217/218) and 98.8% (487/493), respectively, and the combined specificity of the assay was 89.5% (17/19). The combined positive and negative predictive values of the assay were 99.7% (696/698) and 70.8% (17/24), respectively. Studies were also performed on spiked cultures to establish the specificity and performance sensitivity of the method. Staphylococcus QuickFISH has a turnaround time (TAT) of <30 min and a hands-on time (HOT) of <5 min. The ease and speed of the method have the potential to improve the accuracy of therapeutic intervention by providing S. aureus/CoNS identification simultaneously with Gram stain results.
authors.affiliation: AdvanDx Inc., Woburn, Massachusetts, USA.
authors.forename: Melissa K
authors.initials: MK
authors.lastname: Deck
authors.forename: Erica S
authors.initials: ES
authors.lastname: Anderson
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Buckner
authors.forename: Georgia
authors.initials: G
authors.lastname: Colasante
authors.forename: James M
authors.initials: JM
authors.lastname: Coull
authors.forename: Benjamin
authors.initials: B
authors.lastname: Crystal
authors.forename: Phyllis
authors.initials: P
authors.lastname: Della Latta
authors.forename: Martin
authors.initials: M
authors.lastname: Fuchs
authors.forename: Deanna
authors.initials: D
authors.lastname: Fuller
authors.forename: Will
authors.initials: W
authors.lastname: Harris
authors.forename: Kevin
authors.initials: K
authors.lastname: Hazen
authors.forename: Lisa L
authors.initials: LL
authors.lastname: Klimas
authors.forename: Daniel
authors.initials: D
authors.lastname: Lindao
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Meltzer
authors.forename: Margie
authors.initials: M
authors.lastname: Morgan
authors.forename: Janeen
authors.initials: J
authors.lastname: Shepard
authors.forename: Sharon
authors.initials: S
authors.lastname: Stevens
authors.forename: Fann
authors.initials: F
authors.lastname: Wu
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Fiandaca
mesh_terms: D016470:Bacteremia / Q000175:diagnosis* / Q000382:microbiology; D001431:Bacteriological Techniques / Q000379:methods*; D001769:Blood / Q000382:microbiology*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013203:Staphylococcal Infections / Q000175:diagnosis* / Q000382:microbiology; D013210:Staphylococcus / Q000235:genetics / Q000302:isolation & purification*