By Laurie Baratti
Abbott Laboratories announced on August 26 that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for the detection of coronavirus infection. The point-of-care, rapid test, which is highly portable and can be run outside the laboratory system, produces results in just 15 minutes and costs only $5.
Roughly the size of a credit card, BinaxNOW tests are self-contained and require no special equipment in order to process samples or read test results, although they still must be administered by a medical professional.
As with traditional COVID-19 tests, a nasal swab is required to obtain a sample from the patient for testing. Unlike PCR tests, which must be submitted to a lab for processing and the results of which take several days to be reported, BinaxNOW detects antigens (proteins found on the surface of the COVID-19 virus), instead of the virus itself.
The U.S. government has already agreed to purchase 150 million of these rapid tests from Abbott, which will start shipping tens of millions of tests in September, and plans to ramp up production to supply 50 million tests per month at the beginning of October.
Abbott’s clinical study, conducted with several leading U.S. research universities, showed the BinaxNOW COVID-19 Ag Card to have a 97.1-percent sensitivity (meaning that it produces positive results in the presence of the COVID-19 antigen) and 98.5-percent specificity (meaning that it produces negative results when the antigen is not present).
Accordingly, this test can be expected to produce 2.9-percent false negatives and 1.5-percent false positives—meaning that it’s not infallible, but should still go a long way towards identifying and isolating carriers of the virus from the general population.
Under the FDA’s EUA, the BinaxNOW COVID-19 Ag Card can be used only by medical professionals—including doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, etc.—in point-of-care settings operating under CLIA (Clinical Laboratory Improvement Amendments) approval.
While there aren’t currently enough rapid tests to make them widely accessible to travelers or to test everyone passing through U.S. airports, just the notion that a more readily-available, reliable, cheaper and faster testing option is becoming a reality caused airline stocks to shoot upward last week, according to One Mile at a Time.
Abbott is simultaneously releasing NAVICA mobile app, available on both Apple and Android platforms at no charge to patients, that will enable them to display their results when entering certain facilities that require proof of a negative test. The first-of-its-kind app will provide those who test negative with a QR code that serves as a temporary digital health pass, which expires after an interim determined by the organizations that accept it.
"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," said Robert B. Ford, president and chief executive officer of Abbott. "We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."
For more information, visit abbott.com.