Handheld Rapid Antigen Test

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Handheld, Rapid, Extremely Sensitive Assay of SARS-CoV-2 Infections Tech ID: UA21-090 Invention: This invention is a rapid antigen test to detect the presence of SARS-CoV-2 that uses a paper microfluidic chip and a smartphone-based fluorescence microscope. Virus-specific antibody-conjugated fluorescent particles and a biological fluid sample (saliva, mouth gargle, etc.) from the patient are added onto a paper microfluidic chip, causing target antigens to flow through the chip and inducing particle to aggregate. The microfluidic chip is then analyzed using the smartphone-based fluorescence microscope, which can count the aggregated particles one-by-one and quantify the amount of virus in the sample with the extreme limit of detection, down to a single copy. This process occurs rapidly, within minutes, allowing the user to assess their treatment plan quickly after administration of the test. Background: The novel coronavirus, SARS-CoV-2, became a global pandemic in early March 2020. Worldwide, the virus has since killed nearly 1.5 million people and infected 64 million more. One of the key aspects to controlling the spread of the virus is to detect it early through testing and tracing infected individuals. Currently, there are not many diagnostic tests for COVID-19 that rapidly give an individual result. The most commonly available test is an RT-PCR test, results of which usually are not available for a couple of days. Rapid antigen tests are also available, however, its limit of detection and accuracy are not as good as RT-PCR. This test resolves the issue of forcing a suspected infectious individual to quarantine and wait days for their test results while providing extreme limit of detection by providing results within minutes of the administration of the test. Not only does this rapid detection technology allow the individual to assess their treatment needs more quickly, but it also is precise and conveniently available through a user’s smartphone technology. If approved, this technology would be readily available to be scaled to thousands of on-site tests at a low cost.