Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
The FDA announced the update to the Quickvue EUA March 1 with the notation that the rapid antigen test requires a prescription and is indicated for individuals suspected of infection with the SARS-CoV-2 virus within the previous six days. The test is conducted on swab samples from the anterior nares from individuals aged 14 years and older, or on children and adolescents aged 8-13 when an adult obtains the swab specimen. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the authorization is “another example of the FDA working with developers to bring important diagnostics to the public.”
Quidel Corp., of San Diego, previously earned an EUA for a lab-based version of the test in December 2020, which was to be administered within five days of the onset of symptoms. The company was in on the pandemic testing effort in the early months as well, as demonstrated by the EUA granted for the Lyra Direct SARS-CoV-2 assay in May 2020, a test that was also authorized in the European Union. Quidel said in March 1 that the test provides qualitative detection of the nucleocapsid protein antigen, and that the test has been validated for roughly 85% concordance with PCR for positive results, and 99% agreement with PCR for negative findings.
Douglas Bryant, Quidel’s president and CEO, said this “is an important first-step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.” The company has commenced construction on a production facility in Carlsbad, Calif., which will eventually reach a monthly production capacity of 50 million rapid antigen tests.
The U.S. National Institutes of Health announced March 1 that it has launched a study to evaluate whether a smartphone app can reliably guide the user through the steps needed to use the Quidel test. More than 200 have already enrolled in the study, which is supported with the NIH’s Rapid Acceleration of Diagnostics program. Participants will use the test and the app daily for a two-week period. The app, developed by Careevolution LLC, of Ann Arbor, Mich., includes a timer to ensure the steps are followed in the appropriate intervals.
Eurofins snares EUA for home kit
Quidel was not the only company with a new or revised EUA for testing as Eurofins of Luxembourg announced, also March 1, that the FDA has allowed sales of the Empowerdx COVID-19 home collection kit to consumers without a prescription. The kit collects samples for PCR processing and can be ordered online or obtained at pharmacies. The kit includes a prepaid package for shipment, and customers can receive their results within 48 hours via a secure patient portal.
This test was developed by Eurofins’ Viracor subsidiary and is based on an existing Viracor EUA for a PCR assay. Eurofins CEO Gilles Martin said the kit “has the potential to significantly increase population testing rates and help build confidence to accelerate the return of everyday life.” Martin said the company is also working “very closely with European authorities for the approval of similar direct-to-consumer products."
The European Commission (EC) has a list of common rapid antigen tests that enjoy a CE mark and provide 90% sensitivity and 97% specificity for the SARS-CoV-2 virus. The tests on this list must have been validated by at least one member nation, whereupon the test will enjoy mutual recognition from the other member states. Quidel’s Sofia 2 antigen test made the EC list, as did the Panbio test from Abbott Rapid Diagnostics.
Fluidigm adds Rx collection kit
Fluidigm Corp., of South San Francisco, also made a splash in the testing game for the COVID-19 pandemic and announced at the end of January that it had received authorization to market its Advanta PCR assay in the EU. Fluidigm tests were in use in an outreach program for testing unveiled in October 2020, but the company also has an expanded EUA from the FDA. The amended EUA allows the company to run tests on samples collected with the Azova sample kit with the Advanta assay on the company’s Biomark HD platform. This is another at-home collection kit that can be used unsupervised by adults, although in this instance, adult supervision is needed for all aged 17 and younger. The collection kit is available only by prescription, however.