QuidelOrtho Receives First CLIA Waiver for a Flourescent Immunoassay Based COVID-19 Test; Still No Clarity on When the Emergency Use Authorizations for COVID-19 Tests Will Expire

QuidelOrtho Corporation, a leading provider of in vitro diagnostic technologies, announced that its Sofia® 2 SARS Antigen+ FIA test has received CLIA Waiver from the U.S. Food and Drug Administration (FDA). The Sofia 2 SARS Antigen+ FIA was the first rapid antigen test for COVID-19 to be granted FDA market clearance through the FDA’s De Novo process and is now also the first rapid antigen test to receive CLIA waiver. This means that it carries such a low risk of error that it no longer necessitates administration by trained clinical laboratory personnel. This development is poised to expand the use of the test in various point-of-care settings following the end of the FDA’s emergency use authorization for COVID-19 tests. The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023 but the FDA has continued to allow tests to be used that have received emergency use authorization (EUA) from the FDA. Prior to rescinding the EUA for devices, the FDA is required to publish notice in the Federal Register 180 days prior to the termination date. Furthermore, in its Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease, the FDA has stated that it may make exceptions for manufactured devices in distribution. To date the FDA has not provided public indication on when the EUA may end and the FDA also continues to issue EUAs for new COVID-19 tests and has issued four to date for the month of September.

The test identifies the SARS-CoV-2 nucleocapsid protein antigen, generally detectable in upper respiratory specimens during the acute phase of infection. The Sofia 2 SARS Antigen+ FIA test provides results in 10 minutes, representing a 33% reduction in processing time compared to earlier versions. An independent study published in Infection Control and Hospital Epidemiology that compared the Sofia 2 SARS Antigen+ FIA test to real-time polymerase chain reaction (PCR) testing found the test to have a sensitivity of 76.6% (95% confidence interval [CI], 71%–82%), and specificity of 99.7% (95% CI, 99%–100%). The enhanced Sofia 2 SARS Antigen+ FIA Test kit includes features such as pre-filled reagent vials, improved sample extraction, and a user-friendly dropper design for efficient patient sample dispensing. It is recommended that for negative results, it’s advisable to confirm them through a molecular SARS-CoV-2 assay given the potential for false negatives with lateral flow immunoassay tests.