Search Results

The PBC Separator with Selux AST System is an automated inoculum preparation system that uses lysis, centrifugation and sequential optical density measurements to generate a McFarland-equivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods or gram positive cocci by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System Instructions for Use. Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux AST Gram Negative Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below: • Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa · Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris · Ampicillin: Escherichia coli, Proteus mirabilis · Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis • Cefazolin: Escherichia coli, Klebsiella pneumoniae · Cefepime: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa • Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa · Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa · Ceftriaxone: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens • Ciprofloxacin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa • Ertapenem: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens • Gentamicin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa · Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae · Meropenem: Acinetobacter baumannii complex, Citrobacter koser, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa · Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae • Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa • Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux AST Gram Positive Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below: - Ampicillin: Enterococcus faecalis, Enterococcus faecium - Ceftaroline: Staphylococcus aureus - Daptomycin: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus - · Linezolid: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus - Oxacillin: Staphylococcus aureus - Vancomycin: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus The PBC Separator with Selux AST System Gram Positive Panel is a qualitative test for the following antimicrobial agents with the specific target organisms identified below: - · Cefoxitin Screen to predict mecA-mediated oxacillin resistance: Staphylococcus aureus Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.

The Positive Blood Culture (PBC) Separator with Selux AST System is an automated sample preparation instrument with associated consumables that uses lysis, centrifugation, and sequential optical density measurements to prepare a tuned McFarland-equivalent inoculum from positive blood culture bottles that have rung positive on a continuous monitoring blood culture system. Inoculums containing monomicrobial, gram negative or gram positive bacteria are used for Antimicrobial Susceptibility Testing (AST) processing with the Selux AST System. The Selux AST System includes a sample prep station (i.e., AST Workbench), an Inoculator, an Analyzer, Workbench Computer, and the reagents and consumables required to perform AST testing. The PBC Separator and all Selux AST System components are connected to a site workstation, which coordinates sample processing on all instruments. The PBC Separator contains embedded software and a graphical user interface that guides users through the PBC Separator workflow. Once processing of the PBC sample is complete, the user transfers the tuned McFarland inoculum to the Selux AST System for further AST processing. The PBC Separator with Selux AST System can only provide AST results for monomicrobial samples. Since the PBC Separator with Selux AST System does not perform identification (ID), the monomicrobial nature of the sample under test must be confirmed by an FDA-cleared directfrom-positive blood culture ID system. While PBC Separator processing can be performed without species-level ID, this information is required for the Selux AST System to interpret and report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux AST System or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS. The PBC Separator with the Selux AST System utilizes a 384-well panel, either the Selux Gram-Negative Panel or Selux Gram-Positive Panel, that provides parallel results for the antimicrobials indicated for each sample type. The Selux AST System software masks non-indicated results. The average time-to-result for positive blood culture processed with the PBC Separator and Selux AST System is under 7 hours. Principle of Operation The PBC Separator automatically prepares a tuned bacterial inoculum directly from a blood culture bottle sample that "rang" positive on an FDA-cleared continuous monitoring blood culture system, including the Becton Dickinson BACTEC, the bioMerieux BacT/Alert 3D, and the bioMerieux Virtuo. The PBC Separator removes contaminants through repeated centrifugation-wash cycles and specific chemical lysis of mammalian cells and cell fragments. The PBC Separator utilizes an on-board spectrometer to tune the inoculum for the right cell density to perform AST. Tuned inoculums are used with the Selux AST System. The Selux AST System performs AST similarly to the reference broth microdilution method by first incubating samples, then quantifying microbial growth in each well of an antimicrobial dilution series after a growth period, and finally determining the minimum inhibitory concentration (MIC) by comparing growth data in each well, AST testing of PBC samples requires that the Gram type (classification) of the organism be known prior to testing on the Selux AST System as the information is necessary to select the proper AST panel to use. Organism identification (ID) is not needed to initiate testing with the Selux AST System. However, the organism ID is necessary for a result to be interpreted and reported because the MIC-determining algorithm is species-specific as is the interpretative Susceptible (S), Susceptible Dose Dependent (SDD), Intermediate (I), or Resistant (R) determination. Any FDAcleared method may be used to provide an ID including biochemical techniques, matrix-assisted laser desorption/ionization mass spectrometry, and multiplex genetic assays.

The PBC Separator with Selux AST System is an automated inoculum preparation system that uses lysis, centrifugation and sequential optical density measurements to generate a McFarland-equivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System instructions for use. Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux Gram Negative Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below: Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris Ampicillin: Escherichia coli, Proteus mirabilis Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis Cefazolin: Escherichia coli, Klebsiella pneumoniae Cefepime: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Ceftriaxone: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens Ciprofloxacin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Ertapenem: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Gentamicin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae Meropenem: Acinetobacter baumannii complex, Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii. Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.

The Positive Blood Culture (PBC) Separator with Selux AST System is an automated sample preparation instrument with associated consumables that uses lysis, centrifugation, and sequential optical density measurements to prepare a tuned McFarland-equivalent inoculum from positive blood culture bottles that have rung positive on a continuous monitoring blood culture system. Inoculums containing monomicrobial, gram negative bacteria are used for AST processing with the Selux AST System. The Selux AST System includes a sample prep station (i.e., AST Workbench), an Inoculator, an Analyzer, Workbench Computer, and the reagents and consumables required to perform AST testing. The PBC Separator and all Selux AST System components are connected to a site workstation, which coordinates sample processing on all instruments. The PBC Separator contains embedded software and a graphical user interface that guides users through the PBC Separator workflow. Once processing of the PBC sample is complete, the user transfers the tuned McFarland inoculum to the Selux AST System for further AST processing. The PBC Separator with Selux AST System can only provide AST results for monomicrobial samples. Since the PBC Separator with Selux AST System do not perform identification (ID), the monomicrobial nature of the sample under test must be confirmed by an FDA-cleared direct-frompositive blood culture ID system. While PBC Separator processing can be performed without species-level ID, this information is required for the Selux AST System to interpret and report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux AST System or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS. The PBC Separator with the Selux AST System utilizes the Selux Gram Negative Panel, a 384well panel that provides parallel results for the antimicrobials indicated for each sample type. The Selux AST System software masks non-indicated results. The average time-to-result for positive blood culture processed with the PBC Separator and Selux AST System is under 7 hours.

The eQUANT System is an automated inoculum preparation system that uses potentiometric sensing of oxidation-reduction potential changes due to pathogen metabolism to generate a 0.5 McFarland-equivalent suspension (the eMcFarland or eMcF) from positive blood culture samples that can be used for direct, qualitative in vitro susceptibility testing by the agar disk diffusion test method (Kirby-Bauer). Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed as Gram-negative rods by Gram stain. Organism identification must be confirmed by an FDA cleared device for direct testing from positive blood culture before processing samples on the eQUANT System. Evaluation of the eQUANT System's inoculum preparation was conducted for use with agar disk diffusion susceptibility testing and performance was demonstrated for the following antimicrobial agents with Enterobacterales species, Acinetobacter species and Pseudomonas aeruginosa as identified below: Amoxicillin/clavulanate- Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis Ampicillin- Escherichia coli Aztreonam- Citrobacter freundii, Enterobacter cloacae, Escherichia aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Cefazolin- Klebsiella pneumoniae Cefepime- Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Ceftriaxone- Citrobacter freundii, Enterobacter cloacae, Escherichia aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Ertapenem- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella axytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Gentamicin- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella axytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Levofloxacin- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Meropenem- Acinetobacter spp., Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Piperacillin/tazobactam- Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Tobramycin- Citrobacter freundii, Enterobacter cloacae, Escherichia aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.

The eQUANT™ System is an automated system that uses potentiometric sensing of changes in oxidationreduction potential (ORP) during pathogen metabolism to prepare an organism concentration equivalent to a 0.5 McFarland (1-2e8 CFU/ml ± 0.6 log) directly from a positive blood culture. The eQUANT™ System consists of four components: the eQUANT™ Instrument, a single use eTube™ Disposable, a single use eQUANT™ Reagent tube (CAMHB with antifoam), and a workflow tray. The eQUANT™ System processes a single positive blood culture sample at a time. Before processing on the eQUANT™ System, the positive blood culture is confirmed as Gram-negative rods by Gram stain, and a rapid FDA-cleared identification (ID) method for testing from positive blood culture is performed to confirm organism ID. Mixed cultures or organisms identified that are not included in the eQUANT™ System indications for use should not be processed on the eQUANT™ System. Positive blood cultures must be processed immediately on the eQUANT™ System or within 12 hours of blood culture bottle positivity should delays be unavoidable. Once the organism ID is confirmed, 1 mL of eQUANT™ Reagent (cation-adjusted Mueller Hinton broth (CAMHB) supplemented with antifoam (0.0015%) to reduce air bubble formation) is added to the eTube™ Disposable, followed by the addition of 34 µL of the positive blood culture. The eTube™ Disposable with diluted sample is vortexed and then placed in the eQUANT™ System for incubation. Once inserted, the eTube™ Disposable sits in a thermal module which is heated to 37°C ± 2°C to grow the bacteria to a concentration equivalent to a 0.5 McFarland, or eMcF). The eQUANT™ Sensor located in the eTube™ Disposable is an ORP sensor consisting of two electrode components, which both come into direct contact with the diluted positive blood culture sample. The eQUANT™ ORP sensor responds to changes in the ORP during pathogen growth/metabolism. As the concentration of microorganisms in the sample increases, the growth media becomes reduced, and the voltage measured by the ORP sensor becomes more negative. With the organism ID of the tested sample and the blood culture bottle type as inputs to the system, the algorithm is applied to the real-time voltage measurements to determine the point in time at which the organism concentration reaches a level equivalent to a standard 0.5 McFarland. At the endpoint, the sample immediately starts to cool down to 15°C ± 2°C to inhibit further growth. The sample can be held for up to one (1) hour on the instrument, before being used for downstream Disk Diffusion AST testing.