FDA authorizes first at home, over the counter COVID-19 test
The FDA announced it has issued an emergency use authorization for the Cue COVID-19 test, the first at home, over the counter test for COVID-19.
The agency authorized the test for non-prescription, home use in adults for self-swabbing and for children aged 2 years and older when swabbed by an adult.
“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” acting FDA Commissioner Janet Woodcock, MD, said in a press release. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”
The Cue COVID-19 test is a molecular nucleic acid amplification test used to detect genetic material from the SARS-CoV-2 virus in the nostrils. The test includes the single-use test cartridge, a nasal swab, the Cue Cartridge Reader and the Cue Health Mobile Application.
The test identified 96% of positive samples from individuals with known symptoms and 100% in patients without symptoms. The manufacturer, Cue Health, expects to produce 100,000 tests per day by summer 2021.
The FDA previously authorized the Lucira COVID-19 All-In-One Test Kit for at home use. However, the test was authorized for prescription use only.