On Mar. 1, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA, allowing the company to market its new QuickVue At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2.

This test was authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.

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.