Combined COVID-19 - Influenza Clinical Test Expansion

Wisconsin-based Promega announced on January 13, 2021, labs performing the U.S. Centers for Disease Control and Prevention (CDC) Flu SC2 Multiplex Assay, a single test to diagnose infection caused by SARS-CoV-2, influenza A, or influenza B, can now use two Promega instruments and a Promega nucleic acid purification kit in the protocol.

In a letter dated January 8, 2021, the US Food and Drug Administration authorized an amendment to the Emergency Use Authorization for the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay that adds the Maxwell® RSC 48 and Maxwell® CSC 48 instruments, along with the Maxwell® RSC Viral Total Nucleic Acid Purification Kit, as options for the test procedure.

“Multiplex molecular tests are crucial as the flu season overlaps with the COVID-19 pandemic, and we’re glad that Promega can continue to support laboratories by providing them more options as testing evolves and advances,” stated Heather Tomlinson, Director of Clinical Diagnostics at Promega, in a press statement.