Testing and medical device manufacturer Abbott announced Wednesday that it received Food and Drug Administration approval for a portable COVID-19 test.
Called the “BinaxNOW COVID-19 Ag Card,” it is about the size of a credit card and can produce results in 15 minutes. Abbott stated that the test had 97.1% sensitivity (accuracy of diagnosing a positive case) and 98.5% specificity (accuracy of diagnosing a negative case). The test will sell for about $5.
The FDA approved the test under its Emergency Use Authorization. This allows the tests to be performed by physicians, nurses, school nurses, pharmacists, medical technicians, employer occupational health specialists, and others with minimal training and a prescription.
It is potentially a serious breakthrough as most COVID-19 tests must be analyzed by laboratories. Many labs have testing backlogs of up to two weeks, making it impossible for someone to know if he or she is infected in a timely manner. The quick result this test can produce would enable people to know within minutes if they have COVID-19 and take appropriate action to avoid infecting others.
Abbott will also be offering a free mobile app called NAVICA that will allow the user to display his or her test results at facilities requiring proof of testing for entry. The app will be available for both Android and iPhone.
Abbot announced that it will begin producing the test in September, manufacturing 50 million per month by October.
