In the battle against COVID-19, another test just got an Emergency Use Authorization (EUA).
On Friday, October 2, Quidel (QDEL) announced that its Sofia 2 Flu + SARS Antigen FIA test, or the ABC test (flu A and B, and COVID-19) had been granted EUA.
Writing for Raymond James, analyst Andrew Cooper isn’t surprised by the timing, as the company has been confident about having the product ready to go in time for the respiratory season. It should be noted that distributors would have been expected to start building up stock around this point in the year in preparation for the flu season.
As for the test’s performance, it was “largely within the realm of expectations for each pathogen as well, with COVID-19 positive percent agreement of 95% and negative percent agreement of 100% but flu A and flu B sensitivity/specificity of 90%/95% and 89%/96% respectively.”