Abbott's 15-minute, $5 COVID-19 test gets FDA authorization

Just as controversial new recommendations on coronavirus testing arrive from the CDC, the FDA has granted emergency use authorization (PDF) to another rapid COVID-19 testing setup from Abbott. The BinaxNOW COVID-19 Ag Card can produce results in 15 minutes that appear directly on the card, and Abbott has paired it with an app, Navica, that’s intended to work as “temporary digital health pass” for people who test negative. In the press release, Abbott said it’s ramping up to produce up to 50 million tests per month, and will provide it at a price of $5.

The BinaxNow test works with a nasal swab sample and a credit card-sized reactive card to detect the nucleocapsid protein antigen from SARS-CoV-2, and the company says it can be administered at any location by health professionals. If it lives up to the promises, an exec told Bloomberg that it “can be used at a massive scale to help overcome the current waiting game for test results.”

Abbott's BinaxNOW COVID-19 Ag Card is a rapid, reliable and affordable tool for detecting active coronavirus infections at massive scale. (Abbot Laboratories)

It’s an antigen test, as opposed to the slower lab-based PCR testing that has kept people waiting hours, days and weeks for results, and uses a lateral-flow approach similar to home pregnancy test kits. According to the Mayo Clinic, antigen tests work by detecting certain proteins specific to this virus, and work more quickly, but have an increased chance of false-negative results.

Based on a clinical study supported by US research universities, Abbott said its test showed sensitivity of 97.1 percent (correct diagnoses of people who have the disease) and specificity of 98.5 percent (correctly ruling out people who don’t have it), “in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

NAVICA is a no-charge complementary phone app, which allows people to display their BinaxNOW test results. (Abbot Laboratories)

The Navica app is intended to allow entry into places where people will gather, with negative results attached to a QR code. Positive results will result in a message to quarantine and contact a doctor. The “digital health pass” attached to negative results expires after a time period that depends on the organizations that accept the app. The app itself is free for users and available on Android and iOS. It’s not a contact tracing app, but there are obviously privacy concerns attached to sensitive medical information. According to Abbott, the data collected includes “a person's first and last name, email address, phone number, zip code, date of birth and test results.”