| NSF Org: |
TI Translational Impacts |
| Recipient: |
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| Initial Amendment Date: | July 6, 2020 |
| Latest Amendment Date: | July 6, 2020 |
| Award Number: | 2028308 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Anna Brady
abrady@nsf.gov (703)292-7077 TI Translational Impacts TIP Dir for Tech, Innovation, & Partnerships |
| Start Date: | July 1, 2020 |
| End Date: | June 30, 2021 (Estimated) |
| Total Intended Award Amount: | $256,000.00 |
| Total Awarded Amount to Date: | $256,000.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
611 GATEWAY BLVD SOUTH SAN FRANCISCO CA US 94080-7017 (415)938-4300 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
620 Davis St San Francisco CA US 94111-1904 |
| Primary Place of Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): | SBIR Phase I |
| Primary Program Source: |
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| Program Reference Code(s): |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.041 |
ABSTRACT
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is a handheld smartphone-enabled hardware platform for the rapid detection of COVID-19 in nasal swab samples. The proposed project will translate a portable smartphone enabled platform to detect COVID-19 in patient samples in 30-90 minutes in a standard clinical setting or in an even lower-resource facility. After diagnosis, data are immediately recorded and encrypted with geo-mapped and time-stamped for public health use. This novel and proactive approach for detection can enable communities to rapidly detect COVID-19 and monitor outbreak data to suppress disease spread.
This Small Business Innovation Research (SBIR) Phase I project addresses the need to develop a rapid and portable COVID-19 point-of-care diagnostic. The scope of the Phase I project is to develop a robust nucleic acid assay to specifically and sensitively detect for COVID-19 in a handheld smartphone-enabled device. This project proposes an optimized nucleic acid amplification assay that is highly selective and rapid, while maintaining sensitivity, specificity, and a low false positive rate. Additionally, the project will test the optimized assay in the presence of nasopharyngeal (nasal) swabs and viral transport media, preparing a robust platform for clinical analysis of both fresh and stored samples. The project will integrate the assay into a sample-to-answer device for fast COVID-19 nucleic acid diagnosis.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
Between 2020 and 2021 the COVID-19 pandemic infected 213M people worldwide, with 38.2M cases in the US alone. Over this time, resource shortages in diagnostics and vaccines have been one of many contributing factors to not reducing the spread of the virus. Initially, many diagnostic tests for SARS-CoV-2, the COVID-19 causing virus, took days to provide results. However, new diagnostics were developed in this period using novel science and engineering to rapidly identify SARS-CoV-2, sensitively and accurately. For this Phase I SBIR proposal, OmniVis developed a rapid SARS-CoV-2 diagnostic using lower anterior nasal swabs on ahandheld device with readouts in under 30 minutes.
For the NSF Phase I, we proposed three objectives; to develop sample processing with nasal swabs to be compatible with the OmniVis device, to test RT-LAMP for SARS-CoV-2, and to determine the lower limit of detection for COVID-19 RT-LAMP in our rapid hardware device. In the first objective, OmniVis tested nasal fluid and swab types to assess RT-LAMP compatibility and device compatibility. Nylon flocked swabs and nasal fluid were deemed compatible with the assay. The second objective yielded a robust RT-LAMP assay that targeted an RNA region that was highly conserved across SARS-CoV-2 strains. Additionally, the hardware device was used to image RT-LAMP products combined with streptavidin coated particles embedded within the disposable test kit. We declared the lower limit of detection (217 viral genome copies / μL) and conducted blinded studies to determine sensitivity (95%), specificity (95%), false negative rate (2.5%) and device accuracy. OmniVis is part of an ecosystem that bridges clinicians and epidemiologists through rapid COVID-19 detection and automated record keeping of disease detection events, all in one platform. Our technology will aid in COVID-19 disease control efforts by detecting the pathogen rapidly and affordably.
Last Modified: 08/26/2021
Modified by: Katherine N Clayton
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