Quidel, a provider of rapid diagnostic testing solutions and cell-based virology assays, received the CE mark for its Quidel Molecular Direct C. difficile Tox A/B assay for detection of toxigenic Clostridium difficile (C. difficile) bacterial DNA.
The Direct C. difficile Tox A/B assay kit features an extraction-free, three-step sample preparation process which requires no heat-step, no timed step and no centrifugation, as an added benefit.
The direct-to-amplification procedure enables the assay to generate results in less than 60 minutes, Quidel said. The assay is part of the company's molecular diagnostics product line, which includes PCR reagent kits for use by molecular diagnostic laboratories with its existing thermocyclers.
Quidel chief scientific officer Timothy Stenzel said a recent study by the Centers for Disease Control and Prevention suggested nucleic acid amplification tests can be as much as twice as sensitive as enzyme immunoassays.
"Preventing transmission of C. difficile by early and accurate detection in order to isolate and properly treat patients with Clostridium difficile infection is essential to reducing the overall disease burden," Stenzel added.
Quidel Corporation president and chief executive officer Douglas Bryant said the PCR assay, along with the company's CE marked AmpliVue assay and cell culture-based toxin detection system for C. difficile will help meet the testing volume and resource needs for many different types of laboratories.
"In receiving CE mark for our second molecular assay for C. difficile, we have expanded our molecular offering beyond respiratory infections," Bryant added.
According to the company, the Direct C. difficile Tox A/B assay is commercially available in Europe.