I-Corps: Lateral flow home-use diagnostic for detection of COVID-19

The broader impact/commercial potential of this I-Corps project is the development of a rapid test for diagnosis and surveillance of SARS-CoV-2. Given the closing of many testing sites, this rapid test can benefit the public health system. Other testing methods are often expensive, time-consuming, and/or can lead to inaccurate results. The tests developed here may enable substantial cost savings in testing and encourage home self-testing with greater convenience and speed. The tests also have the potential to identify SARS-CoV-2 infection earlier and may be more accurate than other available tests, allowing individuals to receive medical care sooner while also minimizing transmission. This I-Corps project develops a diagnosis process for detection of COVID-19. The proposed technology can be readily modified into either a point-of-care, rapid home diagnostic test or a surveillance testing system. Typical COVID-19 surveillance tests function via either the IgM or IgG antibodies, however these antibodies are often produced late and fade quickly. The proposed diagnostic pipeline developed relies on the use of a different antibody. This custom monoclonal antibody test may improve the overall accuracy of the testing and make the tests more accurate early in the infection period where IgM and IgG based tests can be less accurate. Testing accuracy is improved by using multiple antigens; The use of only one or two antigens has been associated with high rates of false test results with the new variants. 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.