The Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the Abbott ID Now™ COVID-19 test, a molecular point-of-care test that delivers results within minutes, allowing healthcare professionals to make clinical decisions during a patient visit.
According to Abbott, the rapid test, which runs on the ID NOW platform, is an automated assay that uses isothermal nucleic acid amplification technology to detect SARS-CoV-2 viral nucleic acids, providing clinicians with positive results within 5 minutes and negative results within 13 minutes. The Company announced that it expects to deliver 50,000 tests per day beginning this week and will allocate them to the most impacted areas.
“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert B. Ford, president and chief operating officer, Abbott. “With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.”
The FDA issues Emergency Use Authorizations when criteria are met that allow for the use and distribution of a potentially life-saving therapy or diagnostic agent. Additional COVID-19 diagnostics that have received Emergency Use Authorizations can be found here.