US authorises at-home test kit that produces results in 20 minutes

WASHINGTON • The US has authorised its first rapid at-home test for Covid-19, which is available over the counter and produces a result in around 20 minutes.

Manufactured by the Australia-based Ellume, the self-administered, single-use nasal swab test is small enough to fit in the palm of a person's hand.

It is an "antigen" test, meaning it works by detecting a surface molecule of the coronavirus, unlike the more common polymerase chain reaction tests that look for the virus' genetic material.

The test will sell for around US$30 (S$40) and the company plans to roll out three million units next month, and millions more in subsequent months.

Dr Stephen Hahn, commissioner of the Food and Drug Administration, said on Tuesday that the emergency use authorisation represented a "major milestone".

The technology involved is similar to a home pregnancy test.

The Ellume test uses a nasal swab that does not go as far back as the nasopharyngeal swabs used in clinical settings, and is therefore more comfortable to self-administer. The sample is then inserted into a single-use cartridge.

The home test connects with an app on the user's smartphone to interpret the results.

Results take as little as 20 minutes and are delivered via the app to the public health authorities.

Dr Michael Mina, a Harvard epidemiologist who has called for making inexpensive tests widely available, said: "Keeping these tests purely in the free market is a disaster waiting to happen, and reflects an overall lack of public health agency to have a coordinated response."

He added: "These will quickly be bought up by the rich and powerful."

AGENCE FRANCE-PRESSE, BLOOMBERG