CE Mark for Respiratory Infections Molecular Diagnostic Test Announced by Quidel
14 Mar 2012

Quidel Corporation has announced that it has received a CE Mark for the Quidel MolecularTM RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The assay distinguishes between RSV and hMPV, two different viruses that can cause respiratory infections with very similar symptoms.

The Quidel Molecular product line offers PCR reagent kits which can be run by molecular diagnostic laboratories using their existing thermocyclers. Advantages of the reagent kits include their simple transport and storage (refrigerated not frozen), convenient workflow, and quick results. The RSV + hMPV assay shares a common extraction protocol with the Quidel Molecular Influenza A+B PCR assay, they can be batched together in the same multi-well panel for customized multiplexing capability.

"We are very proud to receive CE Mark for RSV + hMPV, our newest Quidel Molecular product offering," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are pleased with our ability to provide healthcare workers in Europe with a diversified set of molecular testing options while also making efficient use of their existing test infrastructure."

This assay is Quidel's third molecular product offering to receive authorization to market in Europe. Quidel Molecular assays for Influenza A+B and hMPV received CE Marking in August and September of last year, respectively. Quidel Molecular RSV + hMPV is not for sale in the U.S. at this time.

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Sonia Nicholas
Clinical Diagnostics Editor