The U.S. Food and Drug Administration has granted emergency-use authorization to Abbott Laboratories for a $5 rapid-response COVID-19 antigen test. The test results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for health care provider organizations and consumers and does not need the use of an analyzer.
A health care professional swabs the individual’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the professional reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.
This test could be used at point-of-care settings, such as a physician’s office, emergency room, or schools. This test has been authorized for use in individuals suspected of COVID-19 by their health care professional within seven days of symptom onset. Given the simple nature of this test, it is likely that these tests could be made broadly available. According to the test manufacturer, Abbott, it plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020. The emergency use authorization was issued to Abbott Diagnostics Scarborough, Inc for its BinaxNOW COVID-19 Ag Card.
The U.S. Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. The agency is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the United State’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Abbott creates products in diagnostics, medical devices, nutrition and branded generic pharmaceuticals. Abbott’s 107,000 employees seek to make an impact on health in more than 160 countries.
This was reported by The U.S. Food and Drug Administration on August 26, 2020.
Contact information: The U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002; 1-888-463-6332; Website: https://www.fda.gov
Contact information: Abbott Diagnostics Scarborough, Inc., 100 Abbott Park Road, Abbott Park, Illinois 60064; 224-667-6100; Website: https://www.abbott.com