FDA issues EUA for at-home COVID-19 test

March 2, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where people can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

Separately, the National Institutes of Health (NIH) announced that a research team has launched a study to assess the performance and usability of a smartphone app paired with the Quidel QuickVue At-Home COVID-19 Test.

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, 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.

The FDA authorized the QuickVue At-Home COVID-19 Test for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with specimens collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

In addition to this new prescription home test, the FDA issued an EUA in December 2020 for Quidel’s QuickVue SARS Antigen Test, which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

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