FDA Approves First At-Home Self-Testing Kit for COVID-19

On November 17, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first at-home self-testing kit for COVID-19.

While many diagnostic tests have received EUAs in recent months, the Lucira COVID-19 All-In-One Test Kit is the first test that can be fully self-administered while offering rapid results at home. 

How Does It Work?

The Lucira test involves placing a self-collected swabbed sample in a vial, which is then inserted within a hand-held test unit. According to the FDA, the test provides results in 30 minutes or less. The light-up display on the test unit indicates whether a person is positive or negative for the SARS-CoV-2 virus. 

The FDA warns that a negative test result from the Lucira test doesn’t rule out the possibility of a COVID-19 infection. According to an official fact sheet for healthcare providers, it may be possible to test a person too early or too late to make an accurate diagnosis. 

The kit includes a molecular single-use test and can be used by people who are at least 14 years old. The FDA has made it mandatory for a healthcare provider to be present for sample collection when the test is performed on those under the age of 14. 

Until now, people have had to visit a hospital, clinic, doctor’s office, or some other testing site for sample collection, which would then be mailed to a lab for analysis. 

The Lucira test is expected to cost $50 or less and will be available by prescription or self-diagnosis. Initially, it will be available on a limited basis in California and Florida. Widespread distribution is expected by spring.  

Ramping up Testing Efforts 

Testing shortages have posed a major roadblock since the pandemic began, crippling the country’s ability to block the spread of the virus. The recent surge in cases has again placed a great deal of strain on our testing capabilities, especially as people rush to get tested before the holidays. 

Lines are again forming at some testing sites. Testing companies and policy experts have already warned that waiting times may start to lengthen. 

An at-home testing kit that provides rapid results may be the key to solving our current predicament. Many experts point to Slovakia’s testing and quarantine scheme as an example. The country of 5.5 million tested 3.6 million over the first weekend of November, cutting the proportion of infections by more than half. 

A similar scheme could work here at home. The widespread availability of the Lucira test could give policymakers the confidence to begin the gradual process of reopening businesses, schools, and other public places. 

Leading COVID-19 Response Efforts     

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