QuidelOrtho, a provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia 2 SARS Antigen+ FIA. 

The Sofia 2 SARS Antigen+ FIA is a rapid antigen test that detects COVID-19 to be awarded FDA market clearance through the FDA’s De Novo process and is now the first rapid antigen test also to receive CLIA waiver. The test is intended for prescription use only and can be used in CLIA-waived point-of-care settings.

With the CLIA waiver, the Sofia 2 SARS Antigen+ FIA is deemed to be so simple and at such low risk of error that it no longer requires administration by trained clinical laboratory personnel, opening broader use in virtually any point-of-care setting equipped with Sofia 2 instruments.

“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, and the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA, it is gratifying to also be the first to receive a full CLIA waiver for our Sofia 2 SARS Antigen+ FIA,” says Douglas Bryant, president and CEO of QuidelOrtho. “In the world of in vitro diagnostics, this qualifies as a trifecta of innovation, advancement and accessibility. This CLIA waiver is further proof of QuidelOrtho’s commitment to product efficacy, ease and ergonomics that help customers reduce costs and speed workflows, ultimately delivering better patient care.”

The Sofia 2 analyzer utilizes QuidelOrtho’s proprietary fluorescent chemistry design, intuitive graphical user interface, and optics system to provide an accurate, objective and automated result in just 10 minutes, a 33% reduction from the breakthrough 15-minute processing time achieved in the first iterations of the Sofia SARS Antigen FIA assay. The Sofia 2 system also comes connected to Virena, QuidelOrtho’s data management system, which provides aggregated, de-identified testing and surveillance data in near real time.

Further reading: QuidelOrtho Receives De Novo FDA Authorization for COVID Rapid Test

The enhanced Sofia 2 SARS Antigen+ FIA Test kit includes other upgraded features, such as pre-filled reagent vials, improved ergonomic sample extraction and a dropper design for easy dispensing of patient samples into the test cassette sample well. The Sofia 2 instrument also offers two distinct workflows. Depending upon the user’s preferred operational method, Sofia 2 SARS Antigen+ FIA test cartridges are either placed directly inside Sofia 2 for automatically timed test development and results read (WALK AWAY Mode), or test cartridges may be placed on the counter or benchtop for a manually timed test development and then placed into Sofia 2 for immediate results read (READ NOW Mode), which allows users to markedly increase testing throughputs per hour.

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in upper respiratory specimens during the acute phase of infection. 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. Positive results do not rule out bacterial infection or co-infection with other viruses, as the agent detected may not be the definite cause of disease.

A negative test is presumptive, and it is recommended these results 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.

Photo: QuidelOrtho