BIOSENSOR 4000 | Mine Safety Appliances (MSA) Co., Inc.

General Description
The BIOSENSOR 4000 offers first responders and emergency medical technicians an automated instrument to further advance biological agent detection in the field, on the ambulance and in the laboratory. The BIOSENSOR 4000 fully automates the detection process from wet or dry sample introduction to result. The assay cartridge enables users to test simultaneously for up to eight pathogens. Unique bioassay technology offers excellent sensitivity and low false positives while offering ease of use in the field. This highly accurate detection method provides rapid measurement of multiple biohazards. Exclusive five minute time-to-answer allows first responders to make informed critical decisions more rapidly than any other biological agent detector. The BIOSENSOR 4000 employs dynamic surface generation, a patent pending type of immunomagnetic assay detection technology. The instrument and technology offer significant advantages over other field and lab based assay methods. Results are displayed with a simple red or green indication. As tests are nondestructive, samples may be retained as evidence. This instrument is IP 67 certified and permanently housed in a sturdy, light weight fully decon-able Pelican case. Research and development has demonstrated that the BIOSENSOR 4000 can identify targets in whole blood and can be utilized as a human diagnostic device.

Technical Description
The BIOSENSOR 4000 employs dynamic surface generation, a patent pending type of immunomagnetic sandwich assay technology.

1. MIX Sample is mixed with the sensing solution which contains: a magnetic component, a fluorescent component and receptors for the biological agent(s) of interest.
2. BIND Sensing materials bind to target during incubation.
3. MAGNETIZE All bound and unbound magnetic material is pulled to surface.
4. WASH All remaining sensing and non-target material is washed away. False positives are virtually eliminated by removing potential interferents.
5. READ Concentrated sample (pellet) is illuminated and emits a signal if target is present.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
1 sample, <10 tests/sample per run
Less than 32 samples every 2 hours
The system or device is currently fully automated
Device or system is intended for multiple detection assays
3 solutions, buffer, eluents, and/or reagents
1 component
No set-up of the system is required
1-2 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a toaster
Between 5 and 25 kg
Wired connections are available
System or device uses batteries
2-4 hours battery life

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at room temperature (27°C)
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
Greater than 10 years expected life
Results can be viewed in real-time
The system could be adapted to a fully autonomous system with some effort
The system software is open and available for modification
The system hardware is open and available for modification

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive FDA approval, no current efforts at this time
Less than 10 µL
Superior specificity. System has a false alarm rate approaching zero (~0%)
100-1,000 CFU per mL
100-1,000 PFU per mL
Less than 1 ng per mL
Spore lysis not necessary for detection by system