Abbott has commenced the shipping of its BinaxNOW COVID-19 Ag Self Test to retailers across the US with availability to consumers expected soon.
A lateral flow immunoassay, the test is intended for the qualitative identification of nucleocapsid protein antigen from SARS-CoV-2 with results obtained in just 15 minutes.
Authorised by the US Food and Drug Administration (FDA) for home use under an emergency use authorisation (EUA), the test can be performed using a self-collected direct anterior nasal swab specimen from people aged 15 years and above or adult-collected samples from children aged two years and above.
Individuals with or without symptoms or other epidemiological causes to suspect Covid-19 can conduct the test twice over three days with a gap of 36 hours between tests.
In the initial stage, the country’s most studied Covid-19 rapid test will be available at CVS Pharmacy, Walgreens and Walmart.
The test can be bought without needing a prescription and will be made available in food, drug and mass merchandisers soon.
Abbott president and CEO Robert Ford said: “Over the past year, Abbott has developed high-quality rapid testing and invested in US facilities to scale up manufacturing so we could bring affordable testing to Americans on a mass scale.
“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 intends to produce tens of millions of BinaxNOW Self Tests on a monthly basis and will expand capacity depending on demand.
To be sold in two-count packs for a manufacturer’s suggested retail price (MSRP) of $23.99, the BinaxNOW Self Test is the most reasonably priced over-the-counter Covid-19 rapid test available in the US.
The latest test utilises the same technology as the currently approved BinaxNOW test, which has been available since last August for serial symptomatic and asymptomatic testing.