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A research team funded by the National Institutes of Health has launched a study to evaluate the performance and usability of a smartphone app combined with the Quidel QuickVue At-Home COVID-19 test, which just received a Emergency Use Authorization (USA) from the US Food and Drug Administration for prescription use. The home test was supported by the NIH through the Rapid Acceleration of Diagnostics (RADx) Initiativewhich 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 which involves daily testing over a two-week period. An app called MyDataHelps, developed by CareEvolution, LLC, provides step-by-step instructions for performing the test and important tools, such as timers, to ensure that the test steps are performed at the correct time intervals. Although users can interpret the test result themselves, the app also provides independent confirmation of the result when the user photographs the test strip with the smartphone camera.
Understanding how people 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 and then a test strip is added. 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, such as QuickVue, become more available, companion smartphone apps are expected to play an important role in their successful use. Apps offer great potential to help people administer tests, track symptoms, and interpret results, ultimately resulting in better test performance and ease of use. In addition to providing valuable guidance, apps can also facilitate reporting of results to public health authorities and healthcare providers.
These technologies are supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. Quidel intends to request an additional EUA from the FDA for the sale of this test without a prescription.
WHO
Bruce J. Tromberg, Ph.D., NIBIB director and RADx Tech program leader, can comment on the COVID-19 testing technology.
About the Rapid Acceleration of Diagnostics (RADx) initiative: The RADxSM initiative was launched on April 29, 2020 to accelerate innovation in the development, commercialization and deployment of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. Leverages existing NIH point-of-care technology research network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary for Health, the Department of Defense, the Biomedical Advanced Research and Development Authority, and the U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the biological sciences to advance basic research and healthcare. NIBIB supports research and development of emerging technologies within its internal laboratories and through grants, collaborations and training. More information is available on the NIBIB website: https://www.nibib.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures of common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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