FDA Issues EUA for First Fully At-Home OTC Diagnostic Test for COVID-19

December 17, 2020

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for coronavirus disease 2019 (COVID-19).

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from a nasal swab sample from any individual aged 2 years and older.

The FDA 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. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.

“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” said Jeff Shuren, MD, FDA’s Center for Devices and Radiological Health, Rockville, Maryland. “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.”

Similar to other antigen tests, 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 with low SARS-CoV-2 prevalence.

Individuals with positive results should self-isolate and seek additional care from their healthcare provider. Individuals who test negative and experience COVID-like symptoms should follow up with their healthcare provider as negative results do not preclude an individual from SARS-CoV-2 infection.

The Ellume COVID-19 Home Test 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 Ellume COVID-19 Home Test 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 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.

Reference: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19...

SOURCE: US Food and Drug Administration