NIH to evaluate COVID-19 at-home testing system

HIN

A research team funded by the National Institutes of Health has launched a study to assess performance and usability of a smartphone app paired with the Quidel QuickVue At-Home COVID-19 Test, which just received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for use with a prescription. The home test was supported by NIH through the Rapid Acceleration of Diagnostics (RADx) initiative, which has spurred the development and commercial availability of millions of COVID-19 tests over the past year.

More than 200 participants have already enrolled in the study that involves daily testing for a two-week period. An app called MyDataHelps, developed by CareEvolution, LLC provides step-by-step instructions for taking the test and important tools such as timers to ensure that the steps of the test are performed at the correct time intervals. Although users can interpret the test result on their own, the app also provides an independent confirmation of the result when the user photographs the test strip with the smartphone camera.

Understanding how individuals interact with these apps and where they find value in them will inform future efforts to advance at-home COVID-19 testing.

The antigen test gives results in just 10 minutes using a nasal swab sample that is placed in a test tube followed by addition of a test strip. The visually read, colored lines that appear on the test strip indicate a positive or negative result — similar to a pregnancy test.

As rapid, at-home COVID-19 tests like QuickVue become more widely available, companion smartphone apps are expected to play an important role in their successful use. Apps offer great potential to assist individuals with administering tests, tracking symptoms, and interpreting results – ultimately resulting in improved test performance and ease-of-use. In addition to providing valuable guidance, apps can also make it straightforward to report results to public health authorities and health care providers.

These technologies are supported by the National Institute for Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. Quidel intends to apply for an additional EUA from the FDA for sale of this test over the counter, without a prescription.

Who

Bruce J. Tromberg, Ph.D., director of NIBIB and lead for the RADx Tech program, can comment on COVID-19 testing technology.

About the Rapid Acceleration of Diagnostics (RADx) initiative: The RADxSM initiative was launched on April 29, 2020, to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. It leverages the existing NIH Point-of-Care Technology Research Network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.

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