FDA Emergency Use Authorization Issued For Smartphone-Paired COVID-19 Test

The demand for accessible diagnostic testing is perhaps at an all-time high. With an increase of Delta variant COVID-19 cases, the beginning of the flu season, and school and public services reopenings upon us, it’s no wonder governments are scrambling to boost home testing initiatives at the behest of the healthcare sector.

Self-testing could prove miraculous in terms of identifying COVID cases without risking transmission via public interactions. It’s an equally beneficial avenue of population protection against individuals wary of or deemed ineligible for vaccination. Many researchers have posited that screening frequency and availability is a more crucial factor for spread reduction than test accuracy/sensitivity. Some countries including the U.K. have responded to the industry scuttlebutt by providing free-of-charge rapid antigen detection tests for a majority of citizens.

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The self-testing model has one significant obstacle: the accuracy of self-administered tests is often inconsistent because of mistakes made by the user in performing or reading the tests. The FDA has acted accordingly by throwing its support behind one of highest test sensitivity-producing options—The BD Veritor At-Home COVID-19 Test recently earned an Emergency Use Authorization. The solution, which uses the Scanwell Health mobile application for user instruction and swab sample collection, was built off of Becton, Dickinson & Co’s Veritor lateral flow antigen test. While the first run of COVID home tests had estimated sensitivity ranging from 76% to 80%, a study showed that BD’s option reached 85%.