Instant Report

Date: 02-Apr-2021

US FDA Grants EUA To Abbotts BinaxNOW Covid-19 Ag Self Test To Detect Covid-19 Infection

Abbott announced it has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW Covid-19 Ag Self Test for detection of Covid-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription.

The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older, bringing the country's most extensively studied and widely used rapid antigen test to nearly everyone in the US. The test will come in a two-count box to meet serial (frequent) testing requirements.

Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to  perform the test (swab, test card, and reagent solution) will come in the box.

"We've now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances," said Robert B. Ford, president and chief executive officer, Abbott. "Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do – like going to work and school or seeing friends and family – with greater confidence."

Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new US manufacturing facilities to produce 50 million tests per month.

Serial testing makes it possible for people to know their infection status when it matters most. And because rapid antigen testing is less expensive, people can test themselves with greater regularity, which is important for those who may be concerned that they were recently exposed or may be attending a large event in close confines.

With results in just 15 minutes, the BinaxNOW Self Test lets people who test positive immediately isolate so that they do not infect others, rather than waiting days for results from a lab or send-away at-home tests. BinaxNOW is proven to be high quality, with a complaint rate for the 150 million professional tests distributed to HHS of 0.0034% as of March 24.

BinaxNOW demonstrates overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts. In our studies, it further shows performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus.

The BinaxNOW Covid-19 Ag Card Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected nasal swab samples from individuals aged two years or older with or without symptoms or other epidemiological reasons to suspect Covid-19 infection, when tested twice over three days with at least 36 hours between tests.