Biocode-1000 | Applied BioCode, Inc.

General Description
Applied BioCode, Inc. (ABC) has combined digital barcodes with immuno and molecular chemistry to create a new, patented Barcoded Magnetic Bead (BMB) technology. The BMBs' barcode patterns give a high-contrast transmitted signal and no fluorescence background, allowing the barcode to be identified easily and accurately, with near 100% decoding accuracy. Barcoded Magnetic Beads, are functionalized with nucleic acids, proteins or other probe molecules, offer the highest multiplex capacities available (up to 128 targets or tests) in one sample in homogeneous media. Optically bar-coded polymer beads are mass produced at low cost by well established semiconductor processes. Biocode-1000 analyzer offers 128 tests per microwell in less than one minute. BMBs have 128 digital codes. Analyzer is a BMB imaging system for a 96-well microplate format. System reads and displays the barcode and fluorescence intensity for each BMB once they settle to the bottom of the well. The Analyzer has an XY translational stage and a 12-bit CCD camera. Typically uses PE (phycoerythrin), but other fluorophores can be used by switching the optical filter sets. Sources: LED for bright field decoding and Lamp for fluorescence detection. Sensitivity: 0.5 fmole of DNA, 1.0 pg/mL protein. Dynamic range: 3-4 orders of magnitude. Beads are 70 x25 x 6 µm. File export to Excel, CSV, and other formats.

Technical Description
Barcoded Magnetic Beads (BMB): From 1 to 128 tests per microwell in 40 seconds! The BMB have 128 digital codes, and a diverse range of bioassay applications can be explored using BMB with the BioCode-1000A Analyzer. BioCode-1000A Analyzer: The BioCode-1000A Analyzer is a rapid BMB imaging system with auto loader for optional robotic loading for a 96-well microplate format. The system rapidly displays the barcode and fluorescence intensity for each BMB. BioCode-1000A Software: The BioCode-1000A software is a powerful, but easy to use control program and user interface for operating the BioCode-1000A Analyzer.

Evaluation Criteria

THROUGHPUT:

2 minutes or less for detection
Multiple samples, multiple tests/sample per run
349-96 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
2 components
Less than 5 minutes is required for set-up
3-5 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Between 25 and 50 kg
System or device has 110V electrical requirement

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
5-10 years expected life
Results can be viewed in real-time
The system could be adapted to a fully autonomous system with significant 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 250 µL
Good specificity. System has a consistently low level of false alarms (2-5%)
1-100 CFU per mL
1-100 PFU per mL
Less than 1 ng per mL
System does not detect spores