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HealthDay News – The first non-prescription COVID-19 test that allows people to take samples at home and get results has been approved by the U.S. Food and Drug Administration for emergency use.
Last week the FDA approved another home test, but samples will need to be sent to a lab to get the results. The new Ellume COVID-19 home test, approved on Tuesday, detects severe coronavirus-2 virus protein fragments associated with acute respiratory syndrome on nasal swab samples from people 2 years and older, according to the FDA. The test uses an analyzer that connects to a smartphone app to make it easier for users to run the test and interpret the results. The results are delivered via smartphone in just 20 minutes.
Jeffrey Shuren, MD, director of the FDA Center for Equipment and Radiological Health, said, “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests done in a laboratory. The fact that it can be used entirely at home and produces results quickly means it can play an important role in responding to the pandemic. ”
When tested, the Ellume COVID-19 home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with symptoms. In people with no symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.
Ellume expects to produce more than 3 million tests in January 2021, the FDA said.
COVID19 Diagnostic Tests General Neurology
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