WASHINGTON—Americans will soon have two options over-the-counter Covid-19 tests as the FDA granted an Emergency Use Authorization (EUA) for an OTC rapid antigen test that will not require a doctor’s prescription.
Approval of the antigen test follows by just 4 days, the FDA’s approval of an OTC PCR test. In announcing its action, the FDA said the “Ellume Covid-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.”
FDA Commissioner Stephen M. Hahn, MD, called the EUA for the antigen test a “major milestone in diagnostic testing for Coovid-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
Since the start of the pandemic the FDA has authorized more than 225 diagnostic tests for Covid-19, but the antigen test is the first that “can be used completely at home without a prescription.”
The FDA did, however, caution that antigen tests are less sensitive and less specific than molecular (PCR) tests. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health.
Because “a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. This is especially true if there are fewer infections in a particular community, as false positive results can be more common when antigen tests are used in populations where there is little COVID-19 (low prevalence).”
The Elhume test “uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs … the [t]est correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.’
The test uses an analyzer that connects with a smart phone app to help users perform the test and understand the results, which are delivered in about 20 minutes as a message to the smartphone. “The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence,” the FDA said.
The test maker said it plans to have 3 million tests available in January 2021.
Peggy Peck, Editor-in-Chief, BreakingMED™
Cat ID: 190
Topic ID: 79,190,190,926,192,927,725,928,925,934