Quidel, a provider of rapid diagnostic testing solutions and cell-based virology assays, has received the CE mark for its Quidel Molecular RSV + hMPV assay for the identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
CE mark approval allows the molecular RSV + hMPV assay to be launched in Europe.
The RSV + hMPV assay can be batched alongside the Quidel Molecular Influenza A+B PCR assay in the same multiwell panel for customised multiplexing capability, the company said. The molecular diagnostic assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms.
Quidel's line of molecular diagnostic products offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers, providing simple transport, refrigerated storage (no freezer required), convenient workflow, a short time to result and other benefits that favourably affect diagnostic test outcomes.
Quidel Corporation president and chief executive officer Douglas Bryant said: "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."
Quidel Molecular RSV + hMPV assay is the company's third molecular product to receive authorisation to be marketed in Europe. Currently, Quidel Molecular RSV + hMPV is not available for sale in the US.
Quidel Corporation manufactures rapid diagnostic testing solutions and cell-based virology assays. The company's products aid in the detection and diagnosis of many critical diseases and conditions, including influenza, respiratory syncytial virus, strep A, herpes, pregnancy, thyroid disease and faecal occult blood.