NEW YORK – The US Food and Drug Administration granted de novo authorization for a COVID-19 antigen test from QuidelOrtho on Wednesday.
The marketing authorization is for the Sofia 2 SARS Antigen+ FIA, making it the first COVID-19 antigen test to receive marketing authorization from the agency using the traditional premarket review process, the FDA said. The Sofia SARS Antigen FIA Control Swab Set also received de novo authorization.
"Today's marketing authorization of the first COVID-19 antigen test underscores our ongoing commitment to maintain access to testing long term," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
"We look forward to working with developers of all test types who are interested in moving their products through our traditional review pathways and encourage those who are ready to do so as soon as possible," he added.
Along with the de novo authorization, the FDA is also establishing special controls including required labeling and performance testing. This action also creates a new, Class II regulatory classification for simple devices to directly detect SARS-CoV-2 viral targets from clinical specimens in point-of-care settings or at-home use, the FDA said, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) pathway whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
"As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, we are pleased to again be the first to receive de novo FDA clearance for our Sofia 2 SARS Antigen+ FIA," said Douglas Bryant, president and CEO of QuidelOrtho, in a statement.
The Sofia 2 analyzer utilizes QuidelOrtho's proprietary fluorescent chemistry, a graphical user interface, and optics system to provide an accurate, objective, and automated result in 10 minutes. The firm noted that this time to results is a 33 percent reduction from the 15-minute processing time achieved in the first iterations of the Sofia SARS Antigen FIA assay.
The Sofia 2 system also comes connected to QuidelOrtho's Virena data management system, which provides aggregated, de-identified testing and surveillance data in near real time.
The enhanced kit also includes pre-filled reagent vials, improved ergonomic sample extraction, and a dropper design for easy dispensing of patient samples. The Sofia 2 instrument offers an automatically timed walkaway mode as well as a manually timed mode to allow increased throughput.
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection when testing is started within six days of symptom onset.
The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests, and is for use by trained clinical laboratory personnel and individuals trained in point-of-care settings and proficient in performing tests using Sofia 2 instruments.
The firm said that positive results indicate the presence of viral antigens of SARS-CoV-2, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status, and that positive results do not rule out bacterial infection or co-infection with other viruses. A negative test is presumptive, and should be confirmed by a molecular SARS-CoV-2 assay. "Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions," QuidelOrtho said.