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mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay. The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.

The mecA XpressFISH assay is a qualitative fluorescence in situ hybridization (FISH) assay which utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) on smears from blood cultures containing Staphylococcus aureus (SA). After the positive blood culture bottle is confirmed to have SA by Staphylococcus QuickFISH BC, an aliquot of the blood culture is incubated with media containing cefoxitin to induce mecA mRNA expression prior to mecA XpressFISH testing. The assay consists of mecA mRNA inducing cefoxitin reagents, a fixation reagent, a hybridization reagent, a wash solution concentrate, coverslip mounting media and a microscope slide which has a sample well, and positive and negative control wells. Results are visualized and interpreted using fluorescence microscopy.

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Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.

Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay

The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth. Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

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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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Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth. Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.

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C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.

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C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures. Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.

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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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S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain. Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth. S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

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