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

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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.”

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