Fujirebio Diagnostics, Malvern, Pa, has begun the clinical testing needed to submit its new SARS-CoV-2 antigen assay for FDA emergency use authorization with the goal of providing the first fully automated antigen test.
The Lumipulse SARS-CoV-2 antigen assay will be available for use on the Lumipulse G1200, a fully automated CLEIA (chemiluminescent enzyme immunoassay) immunoassay instrument. CLEIA technology and automated testing provides increased sensitivity, reproducibility, and throughput over single-use point-of-care tests.
The initial submission to the FDA is expected to be made in early September for nasopharyngeal swab in universal viral transport media. Submissions to expand sample types are expected to follow.
“As the first company to develop a fully automated SARS-CoV-2 antigen test, we expect this innovation to have a positive impact on result turnaround times and laboratory throughput of covid-19 testing,” says Monte Wiltse, president and CEO at Fujirebio Diagnostics.
For more information, visit Fujirebio Diagnostics.
Featured image: The SARS-CoV-2 Antigen Assay will be run on Fujirebio’s Lumipulse G1200, a fully automated CLEIA immunoassay instrument that has a throughput of 120 tests per hour. (Credit: Fujirebio Diagnostics)
