It’s a card. It’s cheap. It comes with a free app. You get accurate and reliable results in just 15 minutes. But this test detects SARS-CoV-2, the virus that causes COVID, and everyone can get one when they need it – no special equipment needed, no lab required.
Is this our future, where “new normal” sort of resembles our old normal?
Time will tell, but the future might be now, and yesterday might turn out to be a big day in the fight against COVID-19.
On Wednesday, the U.S. Food & Drug Administration (“FDA”) granted an Emergency Use Authorization to Abbott Diagnostics Scarborough, Inc. for its new rapid COVID-19 test, the “BinaxNOW COVID-19 Ag Card.” (To be clear, the FDA has not approved the test; FDA Emergency Use Authorization permits the use of unapproved medical products in an emergency when there are no alternatives).
According to Abbott, the company designed the test and app to work together to facilitate a return to normalcy. Abbott will sell the test for $5. The free app will display test results. The company says the app is not for contact tracing and collects only first and last name, email address, phone number, zip code, date of birth, and test results.
Also important: Abbott’s COVID card is an antigen test. According to the Centers for Disease Control, positive results from antigen rests are usually highly accurate but negative results may need to be confirmed with a molecular test (still the “gold standard” in COVID testing). Abbott’s data says its test results are accurate and reliable, demonstrating both high sensitivity with respect to positive results (97.1) and high specificity with respect to negative results (98.5%) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Really important: Abbott’s ability to get the test out there. According to Abbott, the company has “invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.”
Living in COVID world means, for this long moment, living with this virus. For employers, schools, and other organizations searching for ways to move forward – this is a promising development.
We will continue to monitor and analyze these developments.
*Helena Oroz, an OSBA Certified Specialist in Labor and Employment Law, is a member of the firm’s Labor and Employment Groups and regularly advises clients on all employment related matters. If you have questions, please contact Helena at hot@zrlaw.com or (216) 696-4441.