Abbott Reissued FDA Emergency Use Authorization for ID Now COVID-19 Test
By LabMedica International staff writers
Posted on 21 Sep 2020
Abbott (Lake Forest, IL, USA) has been reissued Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the company's ID Now COVID-19 test.Posted on 21 Sep 2020
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; and clarify that testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.
Image: Abbott ID Now (Photo courtesy of Abbott)
The reissuance has 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; and revised the health care provider and patient fact sheets to reflect the intended use updates and language more consistent with recent authorizations.