Brisbane diagnostics company Ellume has won an emergency use authorisation (EUA) from the US Food and Drug Administration for the first over-the-counter (OTC) fully at-home diagnostic test for Covid-19.
According to an FDA statement the Ellume Covid-19 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 said on Wednesday, US time: “Today’s authorisation is a major milestone in diagnostic testing for COVID-19.
“By authorising 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.”
Last week @AuManufacturing reported Ellume will expand its manufacturing facility following a strategic investment from the state government’s Essential Goods and Supply Chain Programme.
Hahn said: “As we continue to authorise 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.”
The announcement follows last month’s FDA authorisation of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample.
The FDA has authorised more than 225 diagnostic tests for COVID-19 since the start of the pandemic.
Similar to other antigen tests, a small percentage of positive and negative results from this test may be false, the FDA said.
Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible.
Subscribe to our free @AuManufacturing newsletter here.