The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without the need to send a sample to a laboratory for analysis.
The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected nasal swab samples from people ages 14 and older or children ages 8 and older with swabs collected by an adult. The test is authorized for those suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a news release. “The QuickVue At-Home COVID-19 test is another example of the FDA working with test developers to bring important diagnostics to the public.”
The antigen test gives results in 10 minutes using a nasal swab sample that is placed in a test tube followed by addition of a test strip. The colored lines that appear on the test strip indicate a positive or negative result, similar to a pregnancy test.
Also today, NIH announced that a research team it funded has launched a study to assess the performance and usability of a smartphone app paired with the Quidel QuickVue At-Home COVID-19 test. NIH supported the development of the home test through its Rapid Acceleration of Diagnostics (RADx) initiative.
More than 200 participants have already enrolled in the study that involves daily testing for a two-week period, according to a news release from NIH. An app called MyDataHelps, developed by CareEvolution, provides step-by-step instructions for taking the test and tools such as timers to ensure that the steps of the test are performed at the correct time intervals. Although users can interpret the test result on their own, the app also provides independent confirmation of the result when the user photographs the test strip with the smartphone camera, the agency said.
These technologies are supported by the National Institute for Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. Quidel intends to apply for an additional EUA from the FDA to sell this test over the counter, without a prescription, according to NIH.
“The flexibility of our QuickVue At-Home COVID-19 test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers,” Quidel president & CEO Douglas Bryant said in a news release. “We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.”
In February, Quidel opened a new factory in Carlsbad, Calif., for its QuickVue line of products. The 128,000 square-foot facility will be the company’s highest-volume production plant in the world and begins operations in the second half of 2021 with a mission to produce 600 million QuickVue SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections. That test received an EUA from the FDA in December.
In December, the FDA granted an EUA to Abbott (NYSE: ABT) for virtually-guided, at-home use of the company’s BinaxNow COVID-19 Ag Card and to Ellume for its Ellume COVID-19 Home test — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales.
This article has been updated with information from NIH and Quidel.