The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for BinaxNOW™ COVID-19 Ag Card (Abbott), a rapid antigen test for the detection of coronavirus disease 2019 (COVID-19) infection.
BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of nucleocapsid protein antigen from severe acute respiratory coronavirus 2 (SARS-CoV-2) in the human nasal cavity. The test has been authorized for use in patients suspected of COVID-19 within 7 days of symptom onset and can be administered by a healthcare professional at the point of care.
After swabbing the patient’s nasal cavity, the sample is rotated onto a test card with a testing reagent added. Results are provided within 15 minutes and can be read directly from the testing card; 1 line indicates a negative result and 2 lines indicate a positive result.
Results from a clinical study showed BinaxNOW COVID-19 Ag Card identified 34 of 35 positive samples (97.1% positive agreement) and 66 of 67 negative samples (98.5% negative agreement) among 102 nasal swabs collected from symptomatic (within 7 days of onset) patients who were suspected of COVID-19. Among patients who presented with symptom onset >7 days, positive agreement was 75% (9 of 12) and negative agreement was 92% (11 of 12); negative results in these patients should be confirmed with a molecular assay if needed for clinical management.
Abbot expects to ship tens of millions of tests in September, and will ramp up to 50 million tests a month by October; the test will cost $5. The Company is also launching NAVICA™, a complementary mobile app for iPhone and Android devices. The app will allow patients with a negative test result to display a temporary digital health pass with the date of the test result.
“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, PhD, professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. “With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”
In a press statement, the FDA noted that antigen tests are very specific; however, they are not as sensitive as molecular tests. Negative results may need to be confirmed with a molecular test prior to making treatment decisions; clinical observations, patient history and epidemiological information should all be considered when evaluating a negative result.
For more information visit fda.gov.
- COVID-19 update: FDA authorizes first diagnostic test where results can be read directly from testing card. https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-read-directly-testing-card. Accessed August 27, 2020.
- Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test receives FDA Emergency Use Authorization; mobile app displays test results to help our return to daily life; ramping production to 50 million tests a month. https://www.prnewswire.com/news-releases/abbotts-fast-5-15-minute-easy-to-use-covid-19-antigen-test-receives-fda-emergency-use-authorization-mobile-app-displays-test-results-to-help-our-return-to-daily-life-ramping-production-to-50-million-tests-a-month-301119289.html. Accessed August 27, 2020.