A low-cost, rapid, and more accurate gel electrophoresis-based assay using DNA nanoswitches for detecting COVID-19 and other viruses.
Viral diagnostics are of prime importance for testing infection rates and for timely treatment, especially in the case of a pandemic such as the current COVID-19 outbreak caused by the SARS-CoV-2 corona virus. On March 11, 2020, the World Health Organization (WHO) declared the coronavirus outbreak a pandemic. Since then, the necessity for large-scale testing of hundreds of thousands of people has become evident. As of May 11, 2020, over 25 million COVID-19 tests were performed worldwide, but more testing is still required. One of the major hurdles to this was the lack of reagents for RT-PCR kits (reverse transcription polymerase chain reaction). While RT-PCR is the gold standard for nucleic acid detection, reliance on a single technique was a bottleneck for testing during the pandemic, coupled with unreliable test results and high costs.
University at Albany researchers are actively working toward COVID-related diagnostics with the following features. They have already established an assay for Zika and Dengue (read research article below) and are currently optimizing the assay for detecting SARS-CoV-2. The DNA nanoswitch assay for diagnosing COVID-19 is a “smart reagent” which undergoes a conformational change from “off” to “on” in the presence of the viral RNA. This assay is (1) non-enzymatic (hence low-cost), (2) requires no amplification (thus minimal false positives), and (3) does not require any expensive instrument to process samples or interpret results (useful for low resource areas). As a truly alternative method, it avoids the bottleneck created by lack of reagents for traditional methods by eliminating complex sample preparation and enzymatic amplification steps. A portable gel unit is the only equipment needed for readouts at testing sites and results from saliva tests can be obtained within 30-60 minutes instead of days. This assay eliminates the need for costly enzymes, equipment, and infrastructure which is critical during pandemics when supply chains are impacted, materials become scarce, and resources are strained.
Further Details:
Programmable low-cost DNA-based platform for viral RNA detection,
https://doi.org/10.1101/2020.01.12.902452
- Eliminating patient pain of current diagnostic tests by providing results from throat swabs for COVID-19 testing.
- Lower cost with no requirement for expensive equipment.
- More reliable with minimal false positives.
- Portable through a gel electrophoresis unit.
- COVID-19 testing (primary application).
- Detection of Zika and Dengue fever viruses (secondary applications).
US Patent Application 63/136,183 for COMPOSITIONS AND METHODS OF ALTERING A NUCLEIC ACID CONSTRUCT WITH RIBONUCLEIC ACID has been filed with the USPTO on 1/11/2021
TRL 4 – technology validated in a lab with a published paper. For SARS-CoV-2, there is soon to be published data on detection in clinical samples.
This technology is available for licensing.
This nanoswitch assay may be translated to a miniature hand-held device. The technology may provide an alternate point-of-care COVID-19 testing method. The possible paths for commercialization are as follows. The technology may be sublicensed to manufacturers for bringing the assay to market. A company potentially licensing this technology may either market the nanoswitch reagents and their own readout device as a viral detection kit or as a diagnostic assay to researchers and clinics/hospitals, respectively.