The FDA Has Approved the First At-Home COVID-19 Test Kit—Here's What You Need to Know About It

One of the biggest factors in controlling COVID-19 is understanding who might be spreading the coronavirus. Currently, most people are tested when they’re symptomatic or have been in contact with someone known to have coronavirus, but arranging for that test—and getting results in a timely manner—can be a hassle.

It may not be long before testing for COVID-19 becomes as simple as self-administering an at-home test. Last week, the Food and Drug Administration issued an emergency use authorization for a home collection kit made by Lucira Health that allows individuals to collect their own nasal swab sample and get results in 30 minutes. While promising, there are also plenty of caveats. Here’s what we currently know about the test.

How does the COVID-19 home test kit work?

The test kit includes a battery-operated diagnostic device, a sample tube, and swab. A person swabs their nostrils, inserts the sample into the tube containing a solution, and then inserts the tube into the device, which looks for genetic material associated with the virus and will display a positive or negative result within 30 minutes. The kit is approved for those 14 years old and up. Those younger than 14 are advised to have a health care provider administer the test.

How effective is the COVID-19 home test kit?

Lucira Health claims that the kit was tested in roughly 100 people who used another FDA-approved test for COVID-19 and compared results. The company says it was 94.1 percent accurate in detecting those who were deemed positive by the other test and 98 percent accurate in detecting negative samples. As with any coronavirus test, it’s possible to get a negative result if the person is tested too early after being exposed to the virus.

Why is the COVID-19 home test important?

Having an individual collect their own sample and get results in 30 minutes allows for those positive for COVID-19 to quarantine immediately, reducing the chances of being around others while infectious. A person could, for example, self-administer the test before going to work or school and know they’re likely to be negative. 

Haven’t there been other COVID-19 tests for home use?

Yes, but those tests typically involve a sample being collected at home and then sent away for laboratory testing. The Lucira Health test is the first to offer both collection and results at home.

Who’s eligible to use the COVID-19 at-home test?

Currently, the kit can only be obtained with a prescription from a doctor, who will likely want to know if a patient is symptomatic before ordering it.

How much does the COVID-19 home test cost?

The single-use test will cost around $50. It’s unclear whether additional sample tubes and swabs will be available for purchase, or if insurance plans will cover the cost.

When will the COVID-19 at-home test be available to the public?

The test is expected to be released for patients of Sutter Health in California and Cleveland Clinic Florida in Miami-Fort Lauderdale, Florida, in the near future. Lucira Health needs to ramp up production to make the test kit widely available, which may not happen until spring 2021. The company plans on asking the FDA to allow the kits to be available to consumers via overnight mail with a doctor’s approval.

[h/t Reuters]