Sept. 22, 2023—QuidelOrtho has been granted a CLIA waiver from the FDA for its Sofia 2 SARS Antigen+ FIA. The rapid antigen test is intended for prescription use only and can be used in CLIA-waived point-of-care settings.
The enhanced test kit includes upgraded features such as prefilled 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 analyzer provides an automated result in 10 minutes and connects to Virena, the company’s data management system, which provides aggregated, de-identified testing and surveillance data in near real time.