Infectious Disease

The FDA initially approves the COVID-19 over-the-counter take a look at at dwelling

March 05, 2021

1 min read

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The FDA announced that it has granted emergency clearance for the Cue COVID-19 test, the first at home, for the over-the-counter test for COVID-19.

The agency approved the test for home nonprescription use in adults for self-wiping and for children 2 years and older if wiped off by an adult.

Photo source: Adobe Stock

“The approval of this new diagnostic test underscores the FDA’s mission to continue to support innovation in testing and provide test developers with the flexibility to increase the availability of accurate and reliable tests to all Americans,” Acting FDA Commissioner Janet Woodcock, MD told a press release . “The FDA will continue to expand Americans’ access to testing to help us fight this pandemic that has killed over half a million people in the United States.”

The Cue COVID-19 test is a molecular nucleic acid amplification test for the detection of genetic material from the SARS-CoV-2 virus in the nostrils. The test includes the disposable test cassette, a nasal swab, the Cue Cartridge Reader and the Cue Health Mobile Application.

The test identified 96% of positive samples from people with known symptoms and 100% from patients without symptoms. The manufacturer Cue Health expects to perform 100,000 tests per day by the summer of 2021.

The FDA previously approved the Lucira COVID-19 All-In-One Test Kit for home use. However, the test has only been approved for prescription use.

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