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US FDA Approves Australian COVID-19 Self-Test Kit

A person uses Ellume's first over-the-counter coronavirus disease (COVID-19) antigen test, which can be used at home, in this undated handout imag

A rapid over-the-counter COVID-19 test developed by an Australian company has been given emergency approval in the United States. It will be America's first at-home testing technology that does not require any laboratory involvement to process a result.

The Australian-manufactured test kit uses a nasal swab and then processes the sample through an analyzer connected to a smartphone. Results are delivered in about 20 minutes.

It is the first at-home coronavirus test that does not require a prescription in the U.S. and has been approved by the Food and Drug Administration. The FDA said the technology would ease the burden on laboratories and test supplies and allow Americans to be screened for the virus from the safety of their homes.

The test has been developed by Ellume, a firm based in Brisbane, Australia. The company hopes to manufacture up to 200,000 kits each day by March. The first consignment is expected to be delivered next month.

Ellume founder and chief executive Sean Parsons, a former emergency and intensive care physician, said the self-test will help reduce the spread of COVID-19.

“It is new technology that we created here in Brisbane over a long time, and it is terrific to see this product being approved by the FDA in these tumultuous times to help respond to coronavirus,” he said.

The technology, however, is unlikely to be used in Australia.

“Here in Australia, we do not have that emergency that they have in the U.S.,” said Dr. Paul Kelly, acting chief medical officer. “The other thing that is different here in Australia is we have a very large and deliberately expanded laboratory network using the gold standard of PCR (polymerase chain reaction) testing. We have plenty of capacity there.”

Australia has mostly contained COVID-19. It has recorded about 28,000 infections since the pandemic began, and 908 people have died.

But after months of relative calm and low case numbers, residents in parts of Australia's biggest city were urged Thursday to stay at home for at least three days because of a cluster of new infections. Other states are imposing restrictions on travelers from Sydney's northern beaches region, where the new outbreak is centered.

Authorities are racing to identify the source of the infections. Sophisticated contact tracing has been a key part in Australia’s coronavirus strategy.