August 21, 2020 – Quidel Corporation announced that Quidel has completed its investigation regarding a report of discordant results (False Positives) at a testing location in Vermont, and found no testing site- or product-related issues with the Sofia 2 instrument or the Sofia SARS Antigen FIA.
Quidel received a complaint in Vermont regarding false positive discrepant results among patients who were subsequently tested and found negative by PCR testing. The company says it promptly entered the complaint into its Quality Management System and worked with the testing site to identify a potential root cause. Quidel examined the complaint thoroughly, including an inspection of the testing site, analysis of the site’s data, and a review of approximately 110,000 data points generated at 526 sites in 33 other states currently using Quidel’s product, the company says.
The investigation found that there were no issues with either the testing facility or with the quality of the Sofia products used. The results of the investigation determined that no further actions were necessary, and results were provided to the Vermont Department of Health, the Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA).
Quidel currently sells the Sofia SARS Antigen FIA in the U.S. under Emergency Use Authorization (EUA) by the FDA.