Opti Medical Systems’ COVID-19 Influenza A and B Diagnostic Gets EUA

The FDA has granted Emergency Use Authorization to Opto Medical Systems’ diagnostic test for COVID-19 and influenza A and B.

The OPTI SARS-CoV-2/ Influenza A/B test is authorized for detection and differentiation of SARS-CoV-2, influenza A and/or influenza B virus RNA in nasopharyngeal swab specimens collected from people suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.

Emergency use of the real-time polymerase chain-reaction (RT-PCR) test is limited to laboratories that meet requirements to perform high-complexity tests, the agency said.