Ellume Covid-19 Home Test

The test was also used in a separate NIBIB study to evaluate a smartphone app that gives instructions to users and helps them interpret the results of their COVID-19 at home test.

Ellume covid-19 home test. Ellumes COVID-19 Home Test. But has been authorized by the FDA under an emergency use authorization. The Ellume COVID-19 Home Test has not been FDA cleared or approved.

Do not use this test as the only guide to manage your illness. Ellume has recalled certain lots of its COVID-19 Home Test after confirming that they may provide false-positive results. The first rapid fully at-home test to receive Emergency Use Authorization by the FDA for at-home use without a prescription.

October 6 2021123 PM ET. A handful of rapid at-home tests are available without a prescription including the Abbott BinaxNOW the Ellume Covid-19 Home Test and the Quidel QuickVue At-Home Covid-19 Test. This product has been authorized only for the detection of proteins from SARS-CoV-2 not for any other viruses or pathogens and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use.

It uses so-called antigen technology meaning it looks for fragments of viral proteins. The three testing options now available at CVS include. The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people 2 years of age and older.

But has been authorized by the FDA under an emergency use authorization. Similar to the Ellume COVID-19 test the BinaxNOW test kit uses a rapid antigen test that should provide results in about 15 minutes at home. Ellume COVID-19 Home Test with Azova.

COVID-19 test kit maker Ellume is recalling some at-home tests. The app then reports the results to public health experts. To determine whether an Ellume test you have is affected by the recall.