www.fdanews.com/articles/204497-diasorin-molecular-nabs-ce-mark-for-covid-19-and-flu-test
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DiaSorin Molecular Nabs CE Mark for COVID-19 and Flu Test
September 22, 2021
DiaSorin Molecular has received CE mark certification for its Simplexa COVID-19 Flu A/B Direct testing kit.
The multiplex test detects nucleic acid from the SARS-CoV-2 coronavirus that causes COVID-19 infection as well as viruses that cause influenza A and influenza B from the same patient sample. The assay, which analyzes nasopharyngeal swab samples, is for use on DiaSorin’s Liaison MDX themocycler.
The assay can detect the COVID-19 Delta and Mu variants, plus nine others, and more than 80 influenza strains, the Cypress, Calif.-based company said.