Quidel, a developer of diagnostic solutions, has received CE mark approval for its AmpliVue C. difficile assay.
AmpliVue assay is a hand-held molecular diagnostic test, which is used for the detection of toxigenic C. difficile bacterial DNA.
Quidel said detection of the pathogen is achieved, when a hand-held fully contained detection cassette utilizes lateral flow technology.
Quidel president and chief executive officer Douglas Bryant said the AmpliVue C.difficile assay will allow those labs that have previously opted for traditional methods to provide a sensitive molecular test for patients in their care.
The company also sells other CE marked molecular tests in the real-time PCR format for Influenza A+B, hMPVmdbr and RSV + hMPV.