The Biomedical Advanced Research and Development Authority (BARDA) is working with Quidel Corp. to develop to detect COVID-19 and three additional respiratory viruses.
The two will work together to develop a rapid multi-analyte diagnostic test for use on the Sofia 2 assay system to detect the SARS-CoV-2 virus, the virus that causes COVID-19, within an hour.
“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 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,” officials stated.
The results are provided to users and integrated into a cloud-based mobile platform that can convey test results to public health agencies. This capability could help public health departments monitor the spread of COVID-19 infections and take the appropriate actions to slow the spread.
Also, the test will 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 be submitted to the U.S. Food and Drug Administration in the coming months for Emergency Use Authorization. This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio.