Abbott’s 15-minute COVID-19 test gets FDA approval


Abbott's BinaxNOW COVID-19 Ag Card is a fast, reliable and affordable tool for detecting massively active coronavirus infections.

Abt Laboratories

It is an antigen test, unlike the slower lab-based PCR tests that have people waiting hours, days and weeks for results, and uses a lateral stream approach similar to home pregnancy test kits. According to the Mayo Clinic, antigen tests work by detecting certain proteins specific to this virus, and they work faster, but have an increased chance of false-negative results.

Based on a clinical study supported by American research universities, Abbott said his test showed sensitivity of 97.1 percent (correct diagnosis of people who have the disease) and specificity of 98.5 percent (correctly excluded of people who have not having it), “in patients suspected of having COVID-19 by their healthcare provider within the first seven days of symptom onset.”

NAVICA is a free complementary phone app that lets people view their BinaxNOW test results.

Abt Laboratories

The Navica app is meant to access places where people will gather, with negative results attached to a QR code. Positive results will result in a message after quarantine and contact a doctor. The “digital health pass” attached to negative results expires after a period of time that depends on the organizations that accept the app. The app itself is free for users and available on Android and iOS. It is not an app for tracing contacts, but there are obviously privacy concerns associated with 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.”