August 20, 2020 – Quidel Corporation announecd that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs.
The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits.
Quidel’s Sofia SARS Antigen FIA has always been authorized for use with either nasal or nasopharyngeal swabs specimens. Due to customer preference, the Sofia SARS Antigen kit has been sold only with a nasal swab.
The new kit configuration including nasopharyngeal swabs allows Quidel to increase its weekly delivery of the Sofia Antigen test.
“In our quest to do the most good during the novel coronavirus pandemic, offering our hospital customers another kit configuration with an NP collection device option allows us to work through some of the near-term nasal swab shortages we face to be able to ship more Sofia SARS Antigen FIA kits and thereby enable more patients to be tested,” said Douglas Bryant, president and CEO of Quidel. “We strongly believe that frequent testing using an accurate point-of-care antigen test allows for more successful implementation of contact tracing and self-isolation programs, which are key to help reduce the spread of COVID-19.”
Quidel currently sells the Sofia SARS Antigen FIA in the U.S. under Emergency Use Authorization (EUA) by the FDA.
