COVID-19 News

BARDA partners with Quidel on test for COVID-19, other respiratory viruses

Biomedical Advanced Research and Development Authority (BARDA) and San Diego-based Quidel Corporation entered into a partnership to develop a rapid multi-analyte diagnostic test for use on the Sofia 2 assay system to detect the SARS-CoV-2 virus within an hour.

Results are provided to users and integrated into a cloud-based mobile platform that can convey de-identified test results to public health agencies. This capability could help public health departments monitor the spread of COVID-19 infections, and take action to help decrease the number of infections in their communities.

The company will develop the Quidel Sofia SARS-CoV-2 viral antigen-detection assay as a rapid, sample-to-answer, point-of-care test that is CLIA [Clinical Laboratory Improvement Amendments] waived for possible use in doctors’ offices and sensitive enough for early detection of SARS-CoV-2 in samples taken from people who have COVID-19 symptoms. The test will also simultaneously detect and distinguish other viruses apart from SARS-CoV-2 including respiratory syncytial virus (RSV), influenza A and influenza B.

This SARS-CoV-2 test development project will use clinical respiratory specimen data for submission in the coming months to the U.S. Food and Drug Administration, for the FDA to consider Emergency Use Authorization.

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