Novodiag® C. difficile Assay

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

Gloved hand holding medical device in lab setting.

    Overview

    Documents

    Training

    Easy to Use Solution with PCR Performance1

    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 without preservatives or collected in FecalSwabTM.*

    Smart Simplicity in On-demand Testing

    Pathogenic Strains1

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

    Rapid & Safe Results

    The Novodiag rapid ‘sample-in, result-out’ system, allows the fully automated detection of C. difficile in less than 1 hour.2

    User-Friendly Science

    The user-friendly nature 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.

    Female lab technician observing Panther systems in a lab setting

    Simplify & Scale the Future of Diagnostics

    The Novodiag C. difficile Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high performing assay menu with high throughput automation. Designed to flexibly scale to meet your needs, from a single patient rapid result to population level screening.

    User-friendly Precision Engineering

    A simple and fast way to pinpoint patients most at risk with on-demand testing. The small, quiet, stackable, fully-automated system combines easy-to-use functionality with PCR performance, to bring clinical confidence closer to patients.

    A Practical Workflow

    Step 1

    Lab technician adding sample to cartridge in a lab setting

    Add sample to cartridge and close with the cap

    Step 2

    Lab technician scanning cartridge in a lab setting

    Scan cartridge and sample ID

    Step 3

    Lab technician inserting cartridge into a system in a lab

    Insert cartridge and start test

    Step 4

    Lab technician using touch screen display in a lab setting

    Fully-automated results and clear reporting, LIS connectivity

    Evidence. Insight. Collaboration.

    Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

      *This product is not a product of Hologic and it is manufactured by Copan Italia SpA

      1. Novodiag® C. difficile Instructions for Use V7-0 – May 2022, Espoo, FINLAND; Mobidiag Ltd. 2022
      2. Verification Report Novodiag® C. difficile V2-0

      Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.

      EC Representative Information wherever applicable