Field System | Diagnostic Biosensors, LLC

General Description
The system is designed for use in the field and by consumers. It generates quantitative assay results for samples from a broad range of complex liquid matrixes including blood, urine, and wastewater. Precision electronic detector elements are embedded into a single consumable sample handling cartridge. Customer-supplied capture molecules, and other dried assay reagents, are placed in the cartridge during production. Low cost per assay is achieved through design for manufacturing. Detection elements are commercially available for development of assays and systems. The detector element production process does not harm sensitive biomolecules. Finished detector elements can be machine - assembled into higher level systems without harming onboard biomolecules. The total system is available as a brass board assay development environment. The underlying commercial data acquisition system allows for configurations as a stand-alone custom device or as a user-configurable experimental station. The instrument communicates with a laptop or smart phone via standard USB 2.0 or Bluetooth. Battery power versions are available, standard is 110V AC.

Technical Description
The fundamental detection element is a giant magnetoresistive (GMR) sensor array chip that counts the biospecifically bound magnetic labels at its surface. Magnetic labels are available for a wide range of detectable species including antibodies, DNA, RNA, proteins, toxins, bacteria, cells, and chemicals. The tiny plastic sample handling cartridge contains the detector elements and an interface to the handheld instrument. There are peer reviewed accounts of magnetoresistive biosensors detecting many analytes of interest including, Biological Warfare Agents, proteomic breast and colon cancer markers, food pathogens (e-coli, cryptosporidium), immunological lung cancer markers (IL-6), and more.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
Multiple samples, multiple tests/sample per run
Less than 32 samples every 2 hours
The system or device is currently semi-automated
Device or system is designed for a single use
0-1 solutions, buffer, eluents, and/or reagents
1 component
Less than 5 minutes is required for set-up
1-2 steps are required for detection

LOGISTICS:

An afternoon of training and some technical skills required
Less than 1 kg
Satellite, wireless and wired connections are available
System or device uses batteries
4-8 hours battery life

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at 4°C
Between 6 months and 1 year shelf life
3-5 years expected life
Results can be viewed in real-time
The system could easily be adapted into a fully autonomous system
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
Good specificity. System has a consistently low level of false alarms (2-5%)
Greater than 10,000 ng per mL
100 ppm-1 ppt
Possible system could be adapted to identify aerosolized chemical agent
Possible system could be adapted to identify liquid chemical agent