Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR

Quidel Corporation (San Diego, CA) announced it has updated the performance data for its Sofia SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration (FDA).

Additionally, the U.S. Department of Health and Human Services (HHS) has indicated its intent to purchase both Sofia 2 instruments and the Sofia SARS Antigen FIA for distribution and use in nursing homes.

Under the proposed terms, HHS will purchase 2,000 Sofia instruments and 750,000 Sofia SARS Antigen FIA tests over the next few months to expand access to COVID-19 testing in nursing homes throughout the U.S.

The Sofia SARS Antigen FIA is available to healthcare providers in the U.S. through distribution representatives for:

  • Cardinal Health
  • Fisher Healthcare
  • Henry Schein
  • McKesson
  • Medline

Read More