An Australian-made, at-home rapid COVID-19 testing kit was given emergency approval by the US Food and Drug Administration on Wednesday.
Developed in East Brisbane by biotech company Ellume, the home antigen test will be available without prescription over-the-counter.
The home test kit uses a "mid-turbinate" nasal swab to detect specific proteins of the virus known as antigens. It also comes with a less intrusive adaptor for children two-years-old and above.
The Question of AccuracyThe risk of antigen tests providing false positive or negative results have been well documented since the start of the pandemic as companies race to release virus tests. The FDA alerted health professionals to the risks in a report last month where it revealed that where the prevalence of COVID-19 is as low as 10 percent, 20 out of 100 antigen test may be false positives.
According to Ellume's clinical study of 198 people, the Ellume home COVID-19 test showed it correctly identified 96 percent of positive samples and 100 percent of negatives in individuals with symptoms. It was less successful with negative.
The director of the FDA's Centre for Devices and Radiological Health, Jeff Shuren, said: “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 completed at home and return results quickly means that it can play an essential role in response to the pandemic.
FDA Commissioner Stephen Hahn said Ellume's at-home test authorization is a "major milestone" that will help ease the pressure on laboratories across America.
“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,” said Hahn.
Ellume received $30 million from the U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative in October to fast-track their rapid test.
Ellume is set to provide over three million of their rapid tests in January 2021. It will retail at $39 (US$30) per test. It has not been authorised for use in Australia.