Quidel has obtained CE mark approval for its Molecular direct C difficile Tox A/B assay for the detection of toxigenic Clostridium difficile bacterial DNA.
The Molecular Direct C difficile Tox A/B assay kit is comprised of an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as an added benefit.
The direct-to-amplification procedure of C difficile Tox A/B kit allows the assay to generate result in less than 60 minutes.
Quidel president and chief executive officer Douglas Bryant said this PCR assay, along with the company’s CE marked AmpliVue assay and its 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.