FDA issued an emergency use authorization for the BinaxNow Covid-19 Ag Card rapid test, the first antigen test where results can be read directly from the testing card, a device similar to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not require the use of an analyzer. The BinaxNow test, from Abbott, About Park, Ill, is about the size of a credit card and provides results in 15 minutes using lateral flow technology. To use the test, a healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result. Abbott will sell this test for $5, and the company plans to make up to 50 million tests available monthly in the United States at the beginning of October 2020. In data submitted to the FDA from a clinical study conducted by Abbott with several leading US research universities, the BinaxNow Covid-19 Ag Card demonstrated sensitivity of 97.1% and specificity of 98.5% in patients suspected of covid-19 by their healthcare provider within the first 7 days of symptom onset. “This newcovid-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic.” Abbott is also launch a complementary mobile app for iPhone and Android devices named Navica. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning, and mask-wearing. “We intentionally designed the BinaxNow test and Navica app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” says Robert B. Ford, president and chief executive officer, Abbott. “BinaxNow and the Navica app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.” For more information, visit Abbott.
June 16, 2020
March 3, 2021