Biodesix, Boulder, Colo, and Bio-Rad Laboratories, Hercules, Calif, are collaborating to launch a blood-based immunoassay that identifies antibodies to SARS-CoV-2, the virus that causes covid-19.
The Platelia SARS-CoV-2 total antibody test was granted FDA emergency use authorization in late April. Clinical evaluation demonstrated specificity greater than 99% and diagnostic sensitivity of 98% at 8 days after the onset of symptoms. Crossreactivity testing demonstrated specificity of 100%, with no reactivity against other interfering specimens, including non-SARS-CoV-2 coronaviruses.
“The Platelia SARS-CoV-2 total antibody test helps clinicians determine if a patient has potentially been infected by SARS-CoV-2 and therefore has developed an immune response against the virus,” says Scott Hutton, chief executive officer of Biodesix. “This gives us a more complete understanding of infection rates as well as potential immunity, which will be vital information as we continue working to stop the spread of covid-19.”
Biodesix currently has the capacity to process 14,000 tests per day.