Simultaneous Identification of Staphylococcus aureus and Coagulase

22 A novel rapid PNA FISH method, Staphylococcus QuickFISH, for the direct 23 detection of Staphylococcus species from positive blood culture bottles was 24 evaluated in a multicenter clinical study. The method utilizes a microscope slide 25 with pre-deposited positive and negative control organisms and a self-reporting 26 15 minute hybridization step which eliminates the need for a wash step. Five 27 clinical laboratories tested 722 positive blood culture bottles containing gram28 positive cocci in clusters. The sensitivities for detection of S. aureus and 29 coagulase-negative staphylococci (CoNS) were 99.5% (217/218) and 98.8% 30 (487/493) respectively, and the combined specificity of the assay was 89.5% 31 (17/19). The combined positive and negative predictive values of the assay were 32 99.7% (696/698), and 70.8% (17/24) respectively. Studies were also performed on 33 spiked cultures to establish the specificity and performance sensitivity of the 34 method. Staphylococcus QuickFISH has a turn-around-time (TAT) of <30 minutes 35 and a hands-on-time (HOT) of <5 minutes. The ease and speed of the method has 36 the potential to improve the accuracy of therapeutic intervention by providing S. 37 aureus/CoNS identification simultaneously with Gram stain results. 38 39 on N ovem er 5, 2017 by gest ht://jcm .sm .rg/ D ow nladed fom