New & Noteworthy

October 2023

Rapid Antigen Test for SARS-CoV-2

QuidelOrtho Corporation

QuidelOrtho has been granted CLIA Waiver from the US FDA for its Sofia 2 SARS Antigen+ FIA. As a rapid antigen test that detects COVID-19, the test is intended for prescription use only and can be used in CLIA-waived point-of-care settings. With the CLIA waiver, the test no longer requires administration by trained clinical laboratory personnel, opening broader use in the point-of-care setting equipped with Sofia 2 instruments. 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 10 minutes. The Sofia 2 comes connected to Virena, QuidelOrtho’s data management system, which provides aggregated, de-identified testing and surveillance data in near-real time. The test kit includes 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.

  • QuidelOrtho Corporation
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