Current problems in approved point-of-care (POC) diagnostic testing include:
- Variable results due to membrane, background, etc.
- Visual reading can be highly subjective
- When tests are weakly positive, decision-making is very difficult
- There is a demand for increased sensitivity with newer clinical utilities and markers
- Digital results-reporting is needed for improved data transmission and documentation
- An automated reader system is needed to improve and speed up clinical workflows
The Vigilant Diagnostics solution specifically addresses these problems by automating existing Lateral Flow Assay (LFA) visual reading through the use of the company’s proprietary Thermal Contrast Amplification (TCA) technology, which uses laser energy and an automated reader device.
This technology can amplify read results throughout the depth of the membrane, whereas visual reads are more topical. The benefit is increased sensitivity and reproducibility, while providing faster read times and better accuracy -- i.e., reducing false negatives and false positives -- combined with the benefit of digital reading for new clinical utilities.
In addition, the Vigilant TCA reader supports “walk-away” testing workflow. It provides faster turnaround time with digitalized results, leading to improved data management and data transfer, and supports detecting positive results earlier, reducing test times.
Vigilant Diagnostics has both a worldwide patent issued on its Thermal Contrast Reader, and a continuation in part for Thermal Contrast lateral flow assays (LFAs). This patent focuses on the company’s unique ability to build LFAs that work with Thermal Contrast to increase the sensitivity over existing LFAs by 100-1000 fold.
In addition, the company is working on next-generation thermal contrast technology that will allow multiplexed readings within a microfluidic platform, which improves the speed and sensitivity of readings even over existing Thermal Contrast LFAs. This work is expected to generate additional intellectual property (IP) for the company.
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Vigilant Diagnostics’ proprietary TCA technology increases the point-of-care (POC) marketplace value of existing LFAs by:
- Increasing the sensitivity of existing LFAs while reducing false-negative and false-positive results
- Transitioning from qualitative binary (positive/negative) results to digital, quantitative results
- Increasing reliability and reproducibility of existing POC testing LFA results
- Requires no existing LFA test changes, just use of our TCA reader
- Provides dramatically increased sensitivity, by 250x or more, with minor
- LFA enhancements to the gold nanoparticle to leverage our TCA technology
Vigilant Diagnostic's Competitive Advantages
Technical Advantages Over Other Detection Technologies
- No liquid addition steps are required for response, i.e., enzyme substrates and chemiluminescence triggering reagents
- Lower background -- no auto-fluorescence
- Measures response throughout the membrane, versus more topical optical measurement
- Allows increasing sensitivity to current LFA colloidal gold formats – up to 250X just by using larger colloidal gold particles
- Low sensitivity can be used for molecular diagnostics (e.g., HIV ~10pg/mL).
Larger-Sized Particles Effect Provides Increasing Sensitivity
Increasing the size of the colloidal gold particle in the assay consistently increases assay sensitivity:
- Using Thermal Contrast Technology with a 30nm particle amplifies response by 8 to 32 fold.
- Using a 60nm particle with the same assay can amplify results >32-50 fold.
- Using a 100nm particle with the same assay can amplify results >250 fold.
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