FDA greenlights home COVID-19 testing kits from Quidel, Eurofins

After one year and hundreds of individual diagnostic authorizations for COVID-19, the FDA is now greenlighting more tests that can be performed or started at home, and on a much broader scale. 

Quidel’s QuickVue home antigen test can be completed entirely by the user, without needing to ship a sample to a lab for processing. The kit, available with a prescription, includes a nasal swab and a liquid-filled tube, plus paper test strips that change color within 10 minutes to deliver a result, similar to a home pregnancy test.

It can be self-performed by people ages 14 and up, or with swabs collected by an adult from children as young as 8. The test is intended to be used within the first six days of displaying symptoms.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”

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Meanwhile, the agency also authorized Eurofins’ over-the-counter sample collection kit, available through the company’s subsidiary, empowerDX. 

The kit includes step-by-step instructions, a nasal swab, test tube and a prepaid FedEx envelope for shipping to a lab, which aims to turn around results within 48 hours. The Luxembourg-based Eurofins is also working with European authorities to clear similar direct-to-consumer products, according to CEO Gilles Martin. 

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The FDA authorized its first fully at-home COVID-19 test, developed by Lucira Health, last November. Since then, it has greenlit direct-to-consumer sample kits from LabCorp, as well as an over-the-counter rapid home test from Ellume.

Quidel’s QuickVue test is also designed to be used with a smartphone app, which will be evaluated by the National Institutes of Health. The NIH’s Rapid Acceleration of Diagnostics initiative, or RADx, previously supported the development of Quidel’s home test through its “Shark Tank”-like competition, with funding to help scale up its manufacturing.

An NIH study has enrolled 200 participants for daily testing over a two-week span, with the app offering step-by-step instructions with timers, to make sure the steps are performed at the correct intervals. In addition, it can interpret test results using the smartphone’s camera, though users can also judge them on their own. 

The NIH said that as more home tests become available, smartphone apps are expected to play an important role, by tracking symptoms and report results to public health authorities. Additionally, Quidel plans to apply for an additional FDA authorization allowing its test to be sold over-the-counter without a prescription.