FDA Updates EUA for Abbott ID Now COVID-19 Test

The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:

  • Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.” 
  • Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
  • Clarify that testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.

The reissuance also:

  • Revised the labeling to update specimen transport and storage recommendations and to include results of the FDA SARS-CoV-2 Reference Panel Testing.
  • Updated conditions of authorization to reflect consistency with more recent authorizations.
  • Revised the healthcare provider and patient fact sheets to reflect the intended use updates and language more consistent with recent authorizations.