General Description
Nanosphere (Northbrook, IL) has developed the FDA-cleared Verigene® System, which is comprised of instrumentation and single use Verigene® Test Cartridges (IVDs) based on proprietary gold nanoparticle technology. With the Verigene System, users can accomplish sensitive, accurate, and rapid multiplex detection of nucleic acid and protein targets using enhanced signal-amplification techniques.
Technical Description
We have developed a generically applicable, microarray based nano-probe test. The assay uses a multi-step robotic process, which relies on non-isotropically oriented antibodies on functionalized glass as multiplexed microarrays to capture targets from an assay sample. Functionalized, 130 angstrom diameter gold nano-probes (measured by static light scattering, 5 nm S.D.) also bind to the target through a molecular-scale complex containing antibodies. The target-bound molecular complex is then quantified through silver enhancement of the functionalized gold. Assays in this format can be rapidly configured and implemented for a wide array of potential biomarkers. For example we have demonstrated a robust and ultra-sensitive assay for cardiac troponin with an LOD of less than 500 femtograms per mL serum, and an overall CV of less than 20%. The assay also shows very low background, a broad dynamic range and over 3 logs of linear dose response.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- 1 sample, >10 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
- 5 or more solutions, buffer, eluents, and/or reagents
- Less than 5 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- An afternoon of training and some technical skills required
- Approximately the size of a carry-on luggage suitcase
- Between 25 and 50 kg
- Wired connections are available
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 4°C to 37°C
- Performance is not influenced by relative humidity
- Between 6 months and 1 year shelf life
- Results cannot be viewed in real-time
- The system could be adapted to a fully autonomous system with some effort
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- System currently has 510k clearance
- System currently has FDA approval
- Less than 250 µL
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- Less than 1 ng per mL
- Add on capability that is full or semi-automated for spore lysis