Diagnostic solutions provider Quidel has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its QuickVu at-home Covid-19 test.
The EUA status allows to use the at-home test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2.
Quidel’s test is designated for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.
In addition, the test is designated for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of Covid-19.
With a prescription, the patients are allowed to use the QuickVue at-home test themselves and obtain results within 10 minutes.
The QuickVue at-home Covid-19 test is said to use the same Quidel lateral flow technology.
It features the same SARS CoV-2 rapid antigen test strip and reagent solution, which secured an EUA from the FDA for use in professional settings in December last year.
Quidel president and CEO Douglas Bryant said: “Quidel’s employees have truly risen to the challenge of the SARS pandemic. Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones.
“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.”
In late 2020, the company also expanded its contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative to include the QuickVue at-home Covid-19 test.
Recently, the company commenced the build out of a new 128,000ft² manufacturing facility in Carlsbad of California.
Expected to be operational in the second quarter of this year, the facility aims to produce over 50 million QuickVue rapid antigen tests per month.
