Abbott Begins Shipping Rapid COVID Self-Tests

Abbott began shipping its BinaxNOW COVID-19 Ag Self Test to retailers. The test will be available in the next few days online and in some stores. Broader nationwide availability is expected in the next two weeks as tests work their way through distribution channels.
 
It will be available at CVS Pharmacy, Walgreens, and Walmart. The test, which can be purchased over the counter without a prescription, will then roll out to other major food, drug, and mass merchandisers in the weeks ahead.
 
“Over the past year, Abbott has developed high-quality rapid testing and invested in U.S. facilities to scale up manufacturing so we could bring affordable testing to Americans on a mass scale,” Robert B. Ford, president and CEO, Abbott told the press. “We’re pleased to be working with the country’s leading retailers to provide broad access to this affordable test so that it gets out into the communities that need it most.”
 
Abbott will manufacture tens of millions of BinaxNOW Self Tests per month and can further scale capacity based on demand. Abbott can also work with retailers to prioritize distribution to areas of the country where the virus is surging as additional supply comes online.
 
“Let’s not back down on testing, let’s double down on it,” said Thomas Quinn, M.D., professor of medicine and pathology at the Johns Hopkins School of Medicine. “As long as COVID remains unpredictable, there’s an important role for the corner pharmacy and the central lab to tackle this virus in tandem, which gives this country the best chance to detect and screen for COVID-19.”
 
The CDC advises “a robust and responsive testing infrastructure is essential to our success in stopping the spread of SARS-CoV-2” and provides guidance on the important role both PCR tests and rapid antigen tests play in detecting infections and screening individuals. Abbott will continue bringing accessible testing options and lead the U.S. in supplying COVID-19 tests for use in labs, at the point of care, and now over the counter.
 
On March 31, Abbott received FDA EUA for over-the-counter, non-prescription, symptomatic and 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, bringing the country’s most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count pack to meet serial (frequent) testing requirements.
 
The BinaxNOW Self Test uses the same technology as the existing BinaxNOW test that has been available since August 2020 but is now indicated by the FDA for serial symptomatic and asymptomatic testing, meaning that people should test themselves frequently. 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.
 
Using the BinaxNOW Self 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. 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.
 
Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company’s first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities, and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading.
 
Since its original authorization in August 2020, the BinaxNOW COVID-19 professional use test has gone on to be used by workplaces, additional universities and other organizations throughout the country.