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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.

Intended Use: The Selux AST System is intended to be used for the automated quantitative susceptibility testing for most clinically significant aerobic microorganisms. The Selux AST System does not provide organism identification. Indications for Use: The Selux Gram-Negative Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific gram-negative bacilli to specific antimicrobial agents when used as instructed. The Selux Gram-Negative Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below: - Amikacin: Pseudomonas aeruginosa - Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis - Ampicillin: Escherichia coli, Proteus mirabilis - Ampicillin-Sulbactam: Acinetobacter baumannii complex, Escherichia species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris - Aztreonam: Escherichia coli - 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 - Cefoxitin: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Morganii - Ceftazidime: Citrobacter species (including C. freundii complex, C. koseri), Enterobacter cloacae complex, Escherichia coli, Klebsiella species (including K. aerogenes, K. pneumoniae), Proteus mirabilis, Proteus vulgaris, Serratia marcescens - Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens - Ceftriaxone: Citrobacter freundii complex, Citrobacter koseri, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis - Ciprofloxacin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa - Eravacycline: Citrobacter freundii complex, Enterobacter cloacae complex, Escherichia oxytoca - Ertapenem: Citrobacter freundii complex, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens - Gentamicin: Citrobacter species (including C. freundii complex, C. koseri), Enterobacter cloacae complex, Escherichia coli, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae), Proteus species (including P. mirabilis, P. vulgaris), Pseudomonas aeruginosa, Serratia marcescens - Imipenem-Relebactam: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Pseudomonas aeruginosa - Levofloxacin: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens - Meropenem: Citrohacter freundii complex. Citrobacter cloacae complex. Escherichia coli. Klebsiella oxvtoca, Klebsiella pneumoniae, Morganella morganii. Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens - Meropenem-Vaborbactam: Citrobacter freundii complex, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Morganella morganii, Serratia marcescens - Minocycline: Escherichia coli, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae) - Piperacillin-Tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganii, Proteus mirabilis, Proteus vulgaris - Tobramycin: Pseudomonas aeruginosa - Trimethoprim-Sulfamethoxazole: Enterobacter cloacae complex, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae)

The Selux AST System for antimicrobial susceptibility testing (AST) consists of a Sample Prep Station, an Inoculator, an Analyzer, a computer workstation, and the reagents and consumables required to perform AST testing. The system is operated via software that guides users through the manual sample preparation process and operates the automated Inoculator and Analyzer. The software includes an algorithm that enables the system to determine the susceptibilities of an organism to the variety of antimicrobials under test. The system is designed so that only Gram stain information is required to initiate testing (to select the proper antimicrobial panel, gram-negative or gram-positive). While complete system testing can be performed without species-level identification (ID), this information is required for the system to report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux system or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the system. The system utilizes 384-well panels to provide parallel results for a large number of antimicrobials. Its average time-to-result is under 6 hours, as demonstrated in various studies. Principle of Operation The Selux platform 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 MIC by comparing growth data in each well. The Selux AST test requires that the Gram type (Classification) of the organism be known prior to testing as the information is necessary to select the proper AST panel to use. The organism identification (ID) need not be known for Selux AST processing to be performed. However, the organism ID is necessary for a result to be obtained because the MIC-determining algorithm is species-specific as is the interpretative Susceptible, Intermediate, or Resistant (SIR) determination. Any FDA-cleared method may be used to provide an ID including biochemical techniques, matrixassisted laser desorption/isotherm mass spectrometry, and multiplex genetic assays. To ensure accurate results, the Selux method initiates antimicrobial susceptibility assays only after sufficient microorganism replication has occurred. Following determination of sufficient growth, two complementary metabolic assays are performed that quantify microbial growth, namely an indicator assay to estimate the number of bacteria present and a surface binding assay. These data are input to an MIC-determining algorithm that provides results when organism IDs are available. The sufficient growth assay ensures that the metabolic reagents used for the high-sensitivity organism quantification assays are not added until after sufficient microbial growth has occurred. To get an accurate reading of microbial replication, the sufficient growth assay monitors growth in dedicated AST panel wells that contain organisms and cation-adjusted Mueller-Hinton Broth but no antimicrobials or probes. Sufficient growth assay wells are monitored by fluorescence to those wells which the standard viability assay pair resazurin/methylene blue have been added and/or by optical absorbance. Two probe-based assays, a viability assay and a surface area assay, commence across all wells in the panel after the sufficient growth threshold has been met. Both of these assays are performed in each AST panel well, providing two complementary datasets for each well.

Intended Use: The Selux AST System is intended to be used for the automated quantitative susceptibility testing for most clinically significant aerobic microorganisms. The Selux AST System does not provide organism identification. Indications for Use: The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species to species to specific antimicrobial agents when used as instructed. The Selux Gram-Positive Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below: - Ampicillin: Enterococcus faecium, Enterococcus faecalis - Clindamycin: Staphylococcus aureus, Staphylococcus epidermidis - Ceftaroline: Staphylococcus aureus - Daptomycin: Staphylococcus aureus, Enterococcus faecalis - Delafloxacin: Staphylococcus aureus, Staphylococcus haemolyticus, Enterococcus faecalis - Eravacycline: Staphylococcus aureus, Enterococcus faecalis - Erythromycin: Staphylococcus aureus - Linezolid: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Enterococcus faecium, Enterococcus faecalis - Levofloxacin: Enterococcus faccium, Enterococcus faecalis, methicillin-susceptible Staphylococcus aureus - Minocycline: Staphylococcus aureus - Oxacillin: Staphylococcus aureus, Staphylococcus lugdunensis - Penicillin: Enterococcus faecium, Enterococcus faecalis, Staphylococcus aureus - Trimethoprim: Staphylococcus aureus, Coagulase-Negative Staphylococci (including S. capitus, S. haemolyticus, S. saprophyticus, S. simulans) - Vancomycin: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) (including S. capitus, S. cohnii, S. epidermidis, S. haemolyticus, S. internedius group, S. lugdunensis, S. saprophyticus, S. schleiferi, S. simulans) Enterococcus faecium, Enterococcus faecalis The Selux 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, Staphylococcus lugdunensis

The Selux AST System for antimicrobial susceptibility testing (AST) consists of a Sample Prep Station, an Inoculator, an Analyzer, a computer workstation, and the reagents and consumables required to perform AST testing. The system is operated via software that guides users through the manual sample preparation process and operates the automated Inoculator and Analyzer. The software includes an algorithm that enables the system to determine the susceptibilities of an organism to the variety of antimicrobials under test. The system is designed so that only Gram stain information is required to initiate testing (to select the proper antimicrobial panel, gram-negative or gram-positive). While complete system testing can be performed without species-level identification (ID), this information is required for the system to report susceptibility results. Species ID can be performed by any appropriate method and this information can be either manually input to the Selux system or automatically downloaded from the laboratory information system (LIS) at any time, once the sample ID is entered into the LIS. The system utilizes 384-well panels to provide parallel results for a large number of antimicrobials. Its average time-to-result is under 6 hours, as demonstrated in various studies.