EUA granted for at-home antigen card COVID test

Regulatory NewsRegulatory News | 16 December 2020 |  By 

A home antigen test for COVID-19 newly authorized by the US Food and Drug Administration (FDA) requires a prescription but may be read at home with telehealth assistance. It is currently indicated only for individuals with symptoms and suspected of having COVID-19.
The agency’s green light for the Abbott BinaxNOW COVID-19 antigen card home test comes the day after its emergency use authorization (EUA) for the first at-home over-the-counter test for COVID-19. (RELATED: First OTC, at-home COVID-19 test garners EUA, Regulatory Focus 15 December 2020)
“With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home,” said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health in a press release announcing the EUA. “We will continue to work with test developers to support the availability of more innovative testing options.”
Abbott plans to have 30 million of the tests available in the first quarter of 2021 and another 90 million available the second quarter.
The newly approved BinaxNOW home test for COVID-19 is a different test than the BinaxNOW Ag Card, which is authorized for rapid point-of-care, but not home, use. Through contracts with the US federal government, about 50 million of these point-of-care tests are currently being distributed and used monthly. (RELATED: Rapid standalone COVID antigen test nabs EUA, Regulatory Focus 27 August 2020)
The new at-home antigen card test is indicated for use with self-collected nasal swabs in individuals aged 15 and older, and with adult-collected swabs for children aged 4 years and up. The EUA was issued for individuals “suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset,” according to FDA.
In a press release, Abbott said that the test’s price point will be about $25. In contrast to the Ellume home test authorized the previous day, no external devices are required to read this test. The user of the BinaxNow home test goes through a “guided testing session,” with assistance available through an online portal.
“The virtually guided process preserves the integrity of the testing process and state-mandated reporting obligations, while ensuring equitable access to people who need tests through the prescription process,” wrote Abbott. “Real-time data generated from at-home testing can also help federal and state public health authorities to better understand the extent of an outbreak and take appropriate steps to control its spread.”
The authorization was granted on the strength of home self-testing (or adult testing of a child) performed on 52 people. In comparison to lab-based molecular polymerase chain reaction (PCR) tests, the BinaxNOW test taken at home yielded sensitivity of 91.7% and specificity of 100% for all cycle threshold (Ct) counts.
“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” said FDA Commissioner Stephen M. Hahn, MD, in the press release. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”


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Tags: coronavirus, FDA, US

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