FDA just approved first over-the-counter COVID-19 test for home use

In a major step toward ending the coronavirus pandemic, the United States Food and Drug Administration granted emergency use authorization for the first over-the-counter COVID-19 test for use at home on Dec. 15. The test is made by Australia-based Ellume and delivers results in about 15 minutes.

It does not require a prescription, and it will be available at drugstores and online for about $30. At first, supplies will be limited, but the company expects to produce 3 million tests in January 2021 and to continue ramping up production to 20 million by June 2021.

The test is authorized for users ages 2 and older, with or without symptoms. The company says that the test kit includes a nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer. The analyzer connects to an app that displays and helps interpret the results, and also reports real-time results to health authorities and others for efficient COVID-19 mapping. You can also connect with a health professional through the app.

The approval is a major victory in the fight against the virus, and experts have long called for effective and widespread testing as an important part of the strategy to end the pandemic. Access to testing and the need for tests to be performed by health workers and processed at laboratories have acted as barriers to implementing this strategy.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said in a statement announcing the authorization.

In data submitted to the FDA, the test correctly identified 95% of COVID-19 cases and had a 3% false-positive rate among symptomatic patients compared to a lab-based test.

“This is the first test which is really designed to be a true at-home test yourself and obtain a result,” Sean Parsons, Ellume CEO, told NPR. “This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to church to decrease the chance that they spread it to other people.”

Another at-home test, Abbott Laboratories’ BinaxNOW, had been previously used by healthcare providers but was authorized for emergency use by the FDA on Dec. 16. In contrast to the Ellume test, users must obtain a prescription from a doctor, which they can get remotely through telehealth provider eMed using the Navica app. Patients collect the sample with a nasal swab, and results are available in the app within 15 minutes.

According to Bloomberg, Abbott says that in an ongoing study of 52 people who used the test within a week of developing symptoms, BinaxNOW accurately produced positive results about 92% of the time. The test accurately returned negative tests 100% of the time.

It’s priced at $25 and is available for those 15 and years or older and are experiencing symptoms.  It can be ordered through the Navica smartphone app. Abbott plans to deliver 30 million tests in the first quarter of 2021, and another 90 million in the second quarter.

The first at-home testing kit to be approved for emergency use authorization by the FDA was the Lucira COVID-19 All-in-One test kit, back in November. It can be used at home by individuals aged 14 and older and requires a prescription. It provides results in 30 minutes.