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

这个I-Corps项目的更广泛影响/商业潜力是开发用于诊断和监测SARS-CoV-2的快速测试。 鉴于许多检测点已关闭，这种快速检测可使公共卫生系统受益。其他测试方法通常昂贵，耗时，和/或可能导致不准确的结果。这里开发的测试可以节省大量的测试成本，并鼓励家庭自我测试，更方便和速度。 这些测试也有可能更早地识别SARS-CoV-2感染，并且可能比其他可用的测试更准确，使个人能够更快地接受医疗护理，同时最大限度地减少传播。这个I-Corps项目开发了一种检测COVID-19的诊断程序。 所提出的技术可以很容易地修改成护理点，快速家庭诊断测试或监测测试系统。典型的COVID-19监测测试通过IgM或IgG抗体发挥作用，但这些抗体通常产生较晚且很快消退。 开发的拟议诊断管道依赖于使用不同的抗体。 这种定制的单克隆抗体测试可以提高测试的整体准确性，并使测试更准确的感染期早期，其中IgM和IgG为基础的测试可能不太准确。 通过使用多种抗原提高了检测准确性;仅使用一种或两种抗原与新变体的高错误检测结果率有关。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估而被认为值得支持。

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.