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The first over-the-counter, home-use diagnostic test for Covid-19 has received an emergency use authorisation (EUA) from the United States Food and Drug Administration (USFDA).
The test, from Australia-based Ellume, is a rapid antigen test that runs a liquid sample along a surface with reactive molecules, the FDA said. “It detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older,” it explained.
Calling it a “major milestone” in diagnostic testing for Covid-19, USFDA Commissioner Stephen M. Hahn said, the authorisation allows the test 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. “The authorisation would expand access to testing, reduce the burden on labs and allow people to test from the comfort and safety of their homes,” he added.
A digital diagnostics company, Ellume expects to produce more than three million tests in January 2021.
The EUA to the first self-test OTC Covid-19 diagnostic test follows last month’s authorisation of the first prescription Covid-19 test for home use, the FDA said. The regulatory agency has authorised more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.
Jeff Shuren, director of FDA’s Center for Devices and Radiological Health clarified, “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. 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.”
False positive & negative
Similar to other antigen tests, a small percentage of positive and negative results from this test may be false, it clarified. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, it added.
The FDA added, “All tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience Covid-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.”
“The Ellume Covid-19 Home Test correctly identified 96 per cent of positive samples and 100 per cent of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91 per cent of positive samples and 96 per cent of negative samples,” the regulator said.
“It uses an analyser that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone,” the FDA said.
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