Quidel has gained CE mark for the Quidel Molecular Direct C difficile Tox A/B assay to detect toxigenic Clostridium difficile bacterial DNA.
The Quidel Molecular Direct C difficile Tox A/B assay kits consist of an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation.
The direct-to-amplification procedure allows the assay to generate a result in less than 60 minutes by an economical method, the company said.
Quidel president and chief executive officer Douglas Bryant said the PCR assay, along with CE marked AmpliVue assay and cell culture-based Toxin Detection System for C difficile will help meet the testing volume and resource needs of many different types of labs.
"In receiving CE Mark for our second molecular assay for C. difficile, we have expanded our molecular offering beyond respiratory infections," Bryant added.
