The at-home Covid-19 test allows people aged 14 years and above with a doctor’s prescription to self-test and get results within 10 minutes
Diagnostic testing solutions provider Quidel has secured the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) to market its new QuickVue at-home Covid-19 test.
The EUA allows people aged 14 years and above, who are suspected of Covid-19 by their healthcare provider to use the test at home, within the first six days of the onset of symptoms.
The at-home test, offered only with a prescription, is performed using self-collected anterior nares (NS) swab specimens and provides the results within 10 minutes.
The QuickVue at-home Covid-19 test has been designed for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2, said the company.
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.”
The test was previously authorised for prescription home use with adult-collected anterior NS samples from individuals aged eight years and above, suspected of Covid-19.
QuickVue at-home Covid-19 test deploys Quidel lateral flow technology and features the SARS CoV-2 rapid antigen test strip and reagent solution, which received FDA EUA in December 2020.
The diagnostic solutions firm said that its test has demonstrated 84.8% positive results agreeing with PCR, and 99.1% negative results agreeing with PCR.
Quidel has established QuickVue brand in 1986 to develop rapid diagnostics focusing on women’s health and respiratory diseases.
QuickVue at-home Covid-19 test has been included in the company’s contract with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics initiative.
Furthermore, the company has recently started construction of a new 128,000ft2 manufacturing facility in Carlsbad, California to enhance the production of QuickVue rapid antigen tests.
Bryant added: “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 to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection.
“We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.”