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hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain and is intended for the identification of the following species / families: Gram-positive: Staphylococcus spp., Staphylococcus aureus, Streptococcus spp. Gram-negative: Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae The hemoFISH Masterpanel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory findings. Positive hemoFISH Masterpanel results do not rule out coinfection with organisms not included in the hemoFISH Masterpanel is not intended to monitor treatment for bacteremia. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not identified by the hemoFISH Masterpanel, and for species determination of Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae that are not identified by the hemoFISH Masterpanel.

The hemoFISH Masterpanel identifies bacteria within 30 minutes directly from positive blood cultures. The methodology is based on classical fluorescence in-situ hybridization (FISH) combined with the usage of fluorescently labeled molecular beacons. A solution of fluorescently labeled molecular DNA beacons is dispensed on fixed and perforated cells prepared from a blood culture. The hybridization is carried out at 52°C for 10 minutes. Submerging the slide into a bath containing a stop solution ceases the reaction. Adding a drop of Mounting Medium to each field prevents fading of fluorescence. After applying a cover slip, the slide is ready for examination using fluorescence microscopy.

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GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.

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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. coliIP. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia. Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

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EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.

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EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli /Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. coli/K. pneumoniae, and/or P. aeruginosa.

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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. colifP. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa.

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