Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

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 health care 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 health care provider and patient fact sheets to reflect the intended use updates and language more consistent with recent authorizations.

Testing updates:
- As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.