LumiraDx files EUA request with FDA for SARS-CoV-2 & Flu A/B rapid test
LumiraDx has submitted its SARS-CoV-2 & Flu A/B Test to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA).
The microfluidic immunofluorescence assay can quickly verify infection for patients suspected of flu and/or COVID-19 to aid diagnosis and clinical decision making.
Run on the company’s point-of-care platform, the LumiraDx SARS-CoV-2 & Flu A/B Test is a rapid microfluidic immunofluorescence assay intended for the simultaneous detection of SARS-CoV-2, Influenza A, and Influenza B viral antigen direct from self or clinician collected nasal swab specimens from individuals suspected of viral infection consistent with COVID-19 by their healthcare provider within the first 12 days of the onset of symptoms.
The NIH Rapid Acceleration of Diagnostics initiative supported the development of the test, LumiraDX said.
