Novodiag difficile assay

Novodiag® C. difficile Assay

Fully-automated, on-demand testing that enables fast diagnosis of C. difficile infections.

    Assay Highlights

    The Novodiag® C. difficile assay, performed with the Novodiag System, is a cartridge-based molecular test for qualitative detection of pathogenic Clostridium difficile strains producing toxin B. The test uses stool samples from patients (without preservatives or in FecalSwabTM).

    Smart simplicity in on-demand testing

    Cartridge-based on-demand testing that delivers clinical confidence in approximately an hour.

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    Rapid and Safe Results


    The Novodiag rapid ‘sample-in, result-out’ system, allowing the fully automated detection of C. difficile in less than 1 hour.

    Pathogenic Strains

    The assay detects the gene tcdB, coding for toxin B, a virulence factor expressed by most pathogenic C. difficile strains


    In a retrospective study:
    Sensitivity: 94.0% (100%*)
    Specificity: 99.3% (100%*)

    User Friendly

    The precision engineering of the system means that the Novodiag system can be easily implemented in decentralised settings as well as high risk and hard to reach areas without the need for highly trained personnel.

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    Features and Benefits

    The Novodiag® assays allow a simple and fast way to pinpoint patients most at risk with targeted, multiplex and syndromic on-demand testing.

      Detection of pathogenic strains, producing toxin B

      • Fast diagnosis and infection control implementation
      • Time and cost effectiveness
      • Improved patient outcome
      • Improved workflow and time to results
      • Increased lab revenue

      • Better reproducability, precision, and productivity


      The Novodiag C. difficile assay enables fast on-demand diagnosis of C. difficile infections.

      Instructions for Use

      Please go to our e-labeling portal to download your document.