22 Sep 2020
Posted in Coronavirus
Abbott’s POC COVID-19 FDA revisions will better capture positive cases
Following the Food and Drug Administration (FDA) revision of emergency use authorization (EUA) for Abbott point-of-care (POC) SARS-CoV-2 test, the Abbott ID NOW COVID-19 test;
Dara Lo, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:
“Abbott is the second market leader in POC testing for COVID-19 polymerase chain reaction (PCR) tests, according to GlobalData. The most recent FDA revisions of the EUA for Abbott’s ID NOW COVID-19 test offers some important clarifications such as testing of individuals only within the first seven days of showing symptoms. This will ensure catching the infection while it’s active. If the Abbott ID NOW test is performed outside of this window, it may return a negative result, even though the individual did have COVID-19.
“Another clarification is expanding where the Abbott ID NOW test can be performed. Testing is now authorized for laboratories certified under CLIA and meets the requirements to perform high, moderate or waived complexity tests. Originally, in June, the test was authorized only for use at the POC, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Compliance or Accreditation using the ID NOW Instrument outside of the clinical laboratory environment.
“Abbott’s ID NOW COVID-19 test originally received EUA in March and has since been updated three times. As the pandemic has progressed, so has the information available, and the FDA and Abbott together have updated the guidance on the ID NOW test accordingly.”