A San Diego-based diagnostic health care manufacturer was granted emergency approval Monday for its at-home COVID-19 test by the U.S. Food and Drug Administration and plans to ramp up production in 2021.
The FDA approved the QuickVue At-Home COVID-19 Test under an Emergency Use Authorization, which allows an unapproved medical product to be used in the case of a public health emergency, like the COVID-19 pandemic.
The product will be, in part, manufactured in a new 128,000 square-foot manufacturing warehouse in Carlsbad. Once running at full capacity in the second half of 2021, the facility will have a goal to produce more than 50 million QuickVue rapid tests per month.
“We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future," said Douglas Bryant, president and CEO of Quidel Corporation.
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Quidel's QuickVue At-Home COVID-19 Test is an antigen test that can be used by a person who suspects they may have COVID-19 at home without having to submit their sample to a lab to be analyzed.
A patient can get a prescription from their doctor for the at-home test and conduct the nasal swab test themselves. Within 10 minutes, the QuickVue test will show a red line for a positive result, according to Quidel.
Doctors are encouraged to prescribe the test to patients 14 and older (or 8 and older if an adult conducts the test) within 6 days of showing symptoms, the FDA said. Health care clinics can purchase the test through distributors.
The test provides an accurate positive result nearly 85% of the time and an accurate negative result 99% of the time, when compared to other COVID-19 tests.
Bryant said the approval of the at-home test is an important first step to provide easy access to testing at home.
"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," Bryant said in a news release announcing the FDA approval.
Quidel QuickVue brand has been around since 1986 and has produced rapid diagnostic tests for women's health and other respiratory diseases. Their flu test has been on the makret since 1999.
Quidel also manufactures several other COVID-19 tests that are used by doctors and health care providers through lab testing.
Quidel's headquarters are located in Sorrento Valley but the company has offices and facilities across San Diego, in the Midwest, and across the globe.