The US Food and Drug Administration has issued an Emergency Use Authorization for Abbott's BinaxNow COVID-19 Ag Card, an antigen test for SARS-CoV-2, as 360Dx reports.
According to the Verge, the test costs $5, takes 15 minutes, and is similar in design to a pregnancy test. It needs a nasal swab to be inserted into the card before a colored line appears indicating either the presence or absence of an infection. A study conducted by Abbott found the test to have a sensitivity of 97 percent and specificity of 98.5 percent in patients suspected of having COVID-19 within a week of symptom onset, 360Dx adds.
At In the Pipeline, Derek Lowe notes that such a test could be helpful — if used properly. He points out the EUA is for testing of symptomatic people, which he says is appropriate. If the test were rolled out in a population with a low infection rate, there'd be too many false positives, but if used among people with a higher likelihood of having COVID-19, Lowe says the test could "do a huge amount of good."
"The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it," University of California, San Francisco's Charles Chiu says in a statement issued by Abbott.
The company is also launching a related phone app called Navica that will display patient's results and act as a sort of digital health pass, 360Dx adds.