Roche Receives CE Mark for SARS-CoV-2 and Influenza A/B Rapid Antigen Combo Test

Roche announced on Monday that its SARS-CoV-2 and A/B Influenza rapid antigen test combo has received CE registration for professional use.

Roche stated that it plans to collaborate with South Korean company SD Biosensor to launch sales in countries/regions accepting CE in early January. It also plans to apply for an EUA from the U.S. Food and Drug Administration in early 2022.

Roche previously launched the SARS-CoV-2 Rapid Antigen Test, SARS-CoV-2 Antigen Self-Test, and SARS-CoV-2 Rapid Antibody Test with SD Biosensor in CE countries/regions.

New multiplex assay uses nasopharyngeal swab samples to differentiate SARS-CoV-2 and influenza A/B, providing results within 30 minutes without the need for instrumentation. Roche stated that it is intended for use by healthcare professionals within the first five days of symptom onset in patients.

Roche stated that its sensitivity to SARS-CoV-2 is 84.85%, and its specificity is 98.59%. For influenza A, the positive percentage agreement (PPA) is 81.16%, with a specificity of 100%, while for influenza B, the PPA is 100% and the specificity is 99.04%.

Roche also noted that the performance of the test is not affected by the Omicron variant of SARS-CoV-2.

Roche Diagnostics CEO Thomas Schinecker said, "As we transition from today's global health emergency to tomorrow's endemic phase, this test adds a solution that is crucial for the long-term management of SARS-CoV-2 and seasonal influenza by healthcare systems."