Rapid standalone COVID antigen test nabs EUA

Regulatory NewsRegulatory News | 27 August 2020 |  By 

A COVID-19 antigen test with results that can be read directly from a test card received an emergency use authorization on 26 August, the US Food and Drug Administration (FDA) announced. The standalone test does not need an analyzer for results, making it “fast and efficient for healthcare providers and patients,” according to a statement from the FDA.
An accompanying app opens the possibility of the rapid test results serving as a “health pass” for those who test negative for the novel coronavirus.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a statement. “This means people will know if they have the virus in almost real-time.”
Abbott Diagnostics Scarborough, Inc, received the emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card, a lateral flow immunoassay. The firm’s COVID-19 test builds on technology for other BinaxNOW tests currently in use for malaria, respiratory syncytial virus and other pathogens.
The new test has sensitivity of 97.1% and specificity of 98.5% to detect SARS-CoV2, according to Abbott. Rapid antigen tests are “generally less sensitive than viral tests that detect nucleic acid,” so the clinical circumstances in which these tests are used will determine whether a confirmatory molecular diagnostic test should be used, according to guidance from the Centers for Disease Control and Statistics.
The test is like some home pregnancy tests in design. A nasal swab is applied to the test card along with a reagent, with results able to be read in 15 minutes. A positive COVID-19 test is indicated by a two-line display; one line indicates a negative result.
The EUA for the Abbott rapid test represents the fifth emergency okay for antigen diagnostic tests for SARS-CoV2, the virus that causes COVID-19. All five antigen tests are authorized to be conducted in moderate- and high-complexity Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified laboratories, and also in CLIA-waived patient care settings such as physician offices and clinics, emergency rooms and some schools.
The test is not meant for asymptomatic people, nor is it intended for home use or self-administration. The anterior nasal swab – not a deep nasopharyngeal swab -- is designed to be self-collected under supervision.
The accompanying phone app, dubbed Navica, can also display results, allowing “people who test negative to have a temporary encrypted digital health pass that displays their results,” according to statement from Abbott. Participating patients and “organizations will be able to view and verify the information on a mobile device to help make entry into these places easier,” according to Abbott.
“Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Shuren. Abbott has indicated it plans to be able to make up to 50 million tests per month available in the US by October 2020.


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