Operations: • Can be used from < -21°C to > 42°C (All temperatures) • Components must be stored at 4°C • Performance is not influenced by relative humidity • Between 1 to 3 years shelf life • 5-10 years expected life • Results cannot be viewed in real-time • The system or device is currently fully autonomous • The system software is open and available for modification • The system hardware is open and available for modification Detection: • Greater than 250 µL • Superior specificity. System has a false alarm rate approaching zero (~0%) • 100-1,000 CFU per mL • 100-1,000 PFU per mL • 1-10 ng per mL • Fully automated spore lysis
Operations: • Can be used from 4°C to 37°C • Components must be frozen (-20°C) • Device or system has peak performance at normal relative humidity conditions • Between 6 months and 1 year shelf life • 5-10 years expected life • Results can be viewed in real-time • The system is not capable of autonomy • The system software is closed and not available for modification • The system hardware is closed and not available for modification Detection: • Efforts are underway to achieve 510K clearance • Efforts are underway to achieve FDA approval • Less than 100 µL • Excellent specificity. System has occasional false alarms under certain conditions (<2%) • 100-1,000 CFU per mL • 100-1,000 PFU per mL • Semi-automated spore lysis
Operations: • Can be used from -21°C to 41°C • Device or system has peak performance at normal relative humidity conditions • Between 1 to 3 years shelf life • Greater than 10 years expected life • Results can be viewed in real-time • The system or device is currently fully autonomous • The system software is open and available for modification • The system hardware is open and available for modification Detection: • This system does not test liquids • Poor specificity. System has a consistently high level of false alarms (>10%) • Spore lysis not necessary for detection by system
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