FDA approves first at-home COVID-19 test

Photo (c) Chris Canton - Getty Images

The agency hopes that these efforts will expand access to COVID-19 tests

The U.S. Food and Drug Administration (FDA) has approved its first at-home COVID-19 test from Cue Health. 

This announcement marks the first time a fully at-home test is available to consumers, and the FDA said it hopes that this helps increase access to COVID-19 testing. 

“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” said Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.” 

How do the tests work?

The Cue Health COVID-19 test is a rapid molecular nucleic acid amplification test (NAAT) that operates much in the same way consumers are used to COVID-19 tests with a nasal swab. 

The purchase of one test comes with a single-use test cartridge and a single-use nasal swab. Consumers will also need to purchase a Cue cartridge test reader, which can be saved and reused for future tests. 

After performing the swab test, consumers insert the test cartridge into the reader, and they can download the Cue Health app to get the COVID-19 test results within 20 minutes. The app is available for both Apple and Android users and is free to download. 

The FDA said that the Cue Health COVID-19 tests are slightly more effective at detecting negative test results than positive test results; studies showed a 98.7% efficacy at detecting negative tests and 92.9% efficacy at detecting positive tests. 

The agency also recommends that consumers who get negative results from the Cue Health test but are showing symptoms related to COVID-19 may want to follow up with their healthcare providers. Just like any other COVID test, it may take a few days for the virus to fully show up on the tests, and there is always a risk of false negative/false positive test results. 

The FDA says that consumers can always get a lab-based test, including a PCR test, to confirm COVID-19 results. 

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