FDA authorises first home self-testing kit for COVID-19

By Rachel Arthur contact

- Last updated on GMT

Lucira plans to expand the scope of the EUA next year. Pic: Lucira
Lucira plans to expand the scope of the EUA next year. Pic: Lucira

Related tags: Lucira Health, Us, emergency use authorization, COVID-19

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home.

Lucira says the kit takes around two minutes to use; and gives rapid results within 30 minutes. The $50 kit – which fits in the palm of the hand - provides a simple ‘positive’ or ‘negative’ reading.

The kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. It is authorized for prescription home use with self-collected nasal swab samples in people aged 14+ who are suspected of having COVID-19 by a healthcare provider.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” ​said FDA Commissioner Stephen M. Hahn, M.D.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

Five years in development

The tech has been developed by California’s Lucira Health: which was founded in 2013 and has been working on a rapid identification kit for flu for five years. When the coronavirus pandemic began early this year, Lucira redirected its efforts to COVID-19 testing.

lucira device on cross

It points out the advantages of a home self-testing kit that can provide lab-quality results quickly and conveniently; with early detection helping control the spread of the pandemic.

Lucira's COVID-19 testing kit was compared with one of the most reliable FDA authorized high sensitivity SARSCoV-2 assays available.

The comparative positive results agreed 94.1% of the time across all samples, and 100% of the time excluding samples containing very low levels of virus (at or below 37.5 Ct).

The negative results agreed 98.0% of the time across all samples.

“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,”​ explained Erik Engelson, CEO, Lucira Health.

“Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests.

"Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”

Using the kit

The Lucira COVID-19 All-In-One Test Kit comes with an electronic device (powered by two AA batteries), sample vial, swab and simple instructions. The user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, and then pressed down in the test unit to start the test.

The 'ready' light will blink until a 'positive' or 'negative' green light is illuminated within 30 minutes.

Clinical trials showed that 100% of patients were able to successfully perform the test in around two minutes.

The Lucira COVID-19 All-In-One Test Kit will initially be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale. Availability should expand nationally by early spring next year.

Lucira Health envisions amending or resubmitting an application for a EUA by the second quarter of 2021: which would allow the kit to be delivered via online medical consultation and overnight delivery.  

Estimates suggest that up to 50 to 100 million COVID-19 tests may need to be conducted each month in the US, with as many as 900 million total possible through 2021.

If all US airline passengers were also tested, that would require one billion tests a year. Similarly, testing healthcare workers each week for a year would require another billion tests.

Related topics: Markets & Regulations

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