Feb 21, 2012 - Phyllis Della Latta,d Martin Fuchs,a Deanna Fuller,b Will Harris,a Kevin Hazen,e Lisa L. Klimas,a Daniel Lindao,c Michelle C. Meltzer,a.
Multicenter Evaluation of the Staphylococcus QuickFISH Method for Simultaneous Identification of Staphylococcus aureus and CoagulaseNegative Staphylococci Directly from Blood Culture Bottles in Less than 30 Minutes Melissa K. Deck,a Erica S. Anderson,a Rebecca J. Buckner,b Georgia Colasante,c James M. Coull,a Benjamin Crystal,a Phyllis Della Latta,d Martin Fuchs,a Deanna Fuller,b Will Harris,a Kevin Hazen,e Lisa L. Klimas,a Daniel Lindao,c Michelle C. Meltzer,a Margie Morgan,f Janeen Shepard,a Sharon Stevens,a Fann Wu,d and Mark J. Fiandacaa AdvanDx Inc., Woburn, Massachusetts, USAa; Indiana University School of Medicine, Indianapolis, Indiana, USAb; Health Network Laboratories, Allentown, Pennsylvania, USAc; Columbia University Medical Center, NewYork-Presbyterian Medical Center, New York, New York, USAd; University of Virginia, Charlottesville, Virginia, USAe; and Cedars-Sinai Medical Center, Los Angeles, California, USAf
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