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US regulator approves first rapid at-home Covid-19 antigen test

The FDA said the emergency use authorisation represented a “major milestone.”

File photo. Test tubes with throat swab samples for a Covid-19 Rapid Antigen test
File photo. Test tubes with throat swab samples for a Covid-19 Rapid Antigen test
Image: Naveen Sharma SIPA USA/PA Images

THE UNITED STATES 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.

The test, made by California-based Ellume, will sell for around $30 and the company plans to roll out three million units in January 2021, and millions more in subsequent months.

Stephen Hahn, commissioner of the Food and Drug Administration, said the emergency use authorisation represented a “major milestone.”

“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,” he said.

It is an “antigen” test, meaning it works by detecting a surface molecule of the coronavirus, unlike the more common PCR tests that look for the virus’ genetic material.

The technology involved is similar to a home pregnancy test.

The Ellume test uses a nasal swab that doesn’t 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.

According to the FDA, it correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96 percent of negative samples.

The FDA said that for patients without symptoms, “positive results should be treated as presumptively positive until confirmed by another test as soon as possible.”

It added that individuals with positive results should self-isolate and seek additional care from their health care provider, while people who test negative but experience Covid symptoms should also seek follow up with their health care provider.

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, which requires users to input their zip code and date of birth, to report to public health authorities.

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Ellume developed the test with $30 million in government funding from the National Institutes of Health.

Last month, the European Commission issued a recommendation providing guidance on the use of rapid antigen tests to detect the virus in certain settings. 

The Taoiseach, however, told the Dáil that Irish public health experts are “not converts” to antigen testing.

He said that public health authorities “are not convinced about the efficacy of rapid testing, or antigen testing”.

© – AFP 2020

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