NEW YORK – Mobidiag said on Monday that it has received the CE mark for its Amplidiag Resp-4 molecular diagnostic test for the detection of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus.
The assay rapidly and simultaneously detects the viruses, which can cause similar symptoms, from one patient sample using nasopharyngeal swabs. It runs on the Mobidiag Amplidiag Easy PCR platform, which can process up to 46 samples in about three hours, Espoo, Finland-based Mobidiag said.
The firm said it is currently also developing Novodiag Resp-4, a molecular test using its Novodiag platform for the rapid, on-demand detection of SARS-CoV-2, influenza A/B virus, and RSV. That test will complement the Amplidiag Resp-4 test.
Mobidiag's Novodiag COVID-19 and Amplidiag COVID-19 PCR tests received CE-IVD marking last June.