FDA Gives Abbott’s At-Home Coronavirus Test Emergency Use Authorization
Abbott Laboratories’ at-home coronavirus test has been authorized for emergency use by the U.S. Food and Drug Administration, the company said Wednesday, as the nation is experiencing a surge in cases and testing is in high demand.
Abbott says it expects to manufacture 30 million of its BinaxNOW tests, which will cost $25, in the first quarter of 2021 and another 90 million the following quarter.
The test delivers results in about 15 minutes, according to Abbott, and can be determined from home without sending samples to a lab.
The digital health solutions provider eMed has partnered with Abbott to manage the guided collection process and sends the results to customers and state and local public health authorities through Abbott’s app.
It is necessary to have a prescription and must be done under the supervision of a telehealth provider and within seven days of the onset of symptoms.
The FDA granted emergency use authorization for Ellume’s at-home coronavirus test on Tuesday. Ellume’s test, which will cost around $30, does not require a prescription and will be available for purchase at drugstores or online, a spokesperson told Associated Press. The FDA authorized the first fully at-home coronavirus test, from Lucira Health, in November. Like Abbott’s, a prescription is required. Ellume’s test is authorized for people with and without symptoms while the tests by Abbott and Lucira are only authorized for people who are showing symptoms. The FDA has authorized more than 25 tests that can be done from home, but the sample must be shipped to a lab for processing.
The tests by Abbott and Ellume are antigen tests. Antigen tests are not as sensitive as molecular tests, meaning there is a higher likelihood of a false negative, the FDA said in a statement. Positive results are frequently accurate, but it is possible to generate false positive results. The FDA urged anyone who tests positive to self-isolate and reach out to their health care provider and warned that negative test results are not absolute. Individuals who test negative may need to be tested again, the FDA said, especially if someone continues to experience coronavirus symptoms.