FDA authorizes first at-home COVID-19 test

It’s a step forward, but coronavirus testing still has a long way to go.

November 19, 2020

Fast, accurate at-home COVID-19 test kits could go a long way toward ending the pandemic.

For one, they might increase the number of people who get tested. People who don’t have the time or means to get to a coronavirus testing site, for example, could just have a test sent to them.

They would also keep people who might have the coronavirus at home — even a trip to the doctor’s office is an opportunity for the virus to spread.

In March, early in the pandemic, the (Gates Foundation) and several startups rolled out at-home COVID-19 tests, before being abruptly shut down by the FDA.

In April, the FDA did authorize its first at-home coronavirus test. However, it still required patients to mail their samples to a lab for processing, delaying the results and potentially allowing them to spread the virus to others.

Now, the agency has issued an emergency use authorization for an at-home COVID-19 test that delivers results within 30 minutes — but good luck getting one at this point.

Lucira’s At-Home COVID-19 Test

The kit is the work of California-based Lucira Health.

To use it, a person swabs the inside of their nose, swirls the swab in a liquid-filled vial, and then places the vial in a handheld test unit that looks for the coronavirus’s genetic material. In 30 minutes or less, a light on the unit tells them whether the sample tested positive or negative.

In a validation trial involving more than 100 people, the results from Lucira’s at-home COVID-19 test matched 94.1% of positive results and 98% of negative ones when compared to a highly accurate FDA authorized test.

All of the trial participants were able to self-administer the test without any issue, and the test is expected to cost around $50, compared to about $150 for other approved rapid tests.

So, Lucira’s at-home COVID-19 test delivers fast results, is easy to use, and is almost as accurate as the test a person is likely to receive at a clinic.

However, unlike every other approved COVID-19 test, the FDA is currently requiring a prescription for Lucira’s test.

That means some people will still need to go to a doctor’s office for a prescription or get access to telemedicine — effectively negating one of the benefits of an at-home COVID-19 test in the first place.

Lucira’s at-home COVID-19 test is a step forward, but only a baby step.

The decision is not without its critics.

“A prescription is not required for an at‐home pregnancy test or an at‐home HIV test,” Dr. Jeffrey A. Singer, a senior fellow for the Cato Institute, a libertarian think tank, pointed out in a recent blog post. “Why require one for an at‐home COVID test?”

In any case, until Lucira can scale up manufacturing, only patients served by two healthcare providers — Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale — will even have the option of getting a prescription for the test.

Coronavirus Testing Game Changer

Lucira has plans to address these shortcomings.

Its goal is to have the test available nationwide early in the spring of 2021, and it’s also working on setting up a website for people to use to get a prescription, saving them from having to visit a doctor’s office or clinic.

If we can get a test that everyone wakes up and takes, it’ll stop the vast majority of transmission.

Michael Mina

For now, though, the FDA’s authorization of Lucira’s at-home test kit is a step forward in coronavirus testing, but only a baby step.

We’re still waiting for that major leap: an at-home COVID-19 test that’s fast, cheap, accurate, and widely available without a prescription, one that people could use regularly to screen themselves for the virus, even when they aren’t feeling sick.

“If we can get a test that everyone wakes up and just like they put in their contact lenses, they take a test, and if it turns positive, they stay at home…it will stop the vast majority of transmission and cause these outbreaks to disappear in a matter of weeks,” Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, told reporters in August.

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