First Rapid COVID-19 Antigen Test Gets Green Light
In a potential game-changer in the ongoing fight to expand COVID-19 testing, the FDA has authorized a new kind of test that can be used by certain health care providers on-site to diagnose patients with the SARS-CoV-2 virus within minutes instead of days.
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BinaxNOW rapid tests, the size of a credit card with no other equipment required, are sold directly to organizations at $5 each and an at-home version, with use guided through digital links, is available at $25 per test. It can be paired with NAVICA app, allowing consumers to display negative results through a temporary digital health certificate.
Ellume Health’s COVID-19 Home Test isn’t just a relatively fast, accurate and easy-to-administer antigen diagnostic, but it’s also available over-the-counter, which greatly expands public access to such tests.
An alert from the agency warns that the tests, which have become widely used for their speed and portability, carry a risk of false positives.