In its latest anti-COVID-19 effort, the U.S. Food and Drug Administration (FDA) gave an Emergency Use Authorization (EUA) to LumiraDx UK Ltd’s SARS-CoV-2 Ag Test, a flexible, scalable, low cost antigen test that works directly off of nasal swab specimens.
The test is meant for use within the first 12 days of symptom onset, by certified labs. According to Adm. Brett Giroir, M.D., the Assistant Secretary for Health, the novel test will help expand testing platforms for SARS-CoV-2, the virus which causes COVID-19.
“This technology has built-in digital connectivity, almost everything we hope for in new testing platforms coming to market,” Giroir said. “Furthermore, its flexibility to perform diagnostic assays to detect indicators of various diseases, including inflammatory markers, could be transformative in providing improved access to quality health care.”
Labs cleared under the Clinical Laboratory Improvement Amendment (CLIA) to perform moderate, high, or waived complexity tests will be able to utilize the Ag Test now. This also applies to patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.