The C. difficile Test is a rapid qualitative immunochromatographic test intended for professional in vitro diagnostics. It enables the simultaneous detection of three markers associated with the bacterium Clostridium difficile: GDH, toxin A, and toxin B. The test is performed using a fecal sample.

Clostridium difficile is a bacterium that can proliferate in the intestines, particularly when the natural bacterial flora has been disrupted, such as after antibiotic therapy. Toxin-producing strains of C. difficile can cause infections of varying severity—ranging from mild diarrhea to pseudomembranous colitis. The detection of GDH, toxin A, and toxin B can aid in the diagnosis of Clostridium difficile infections.

The test provides a result as early as 10 minutes after sample application. The result is presented qualitatively—as test lines in separate windows for GDH, toxin A, and toxin B. The result should not be interpreted after 20 minutes.

This product is intended for professional use. This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: feces
• Quick and easy test procedure
• High-quality product
• Fast results in just 10 minutes!
• Single-use package
• Product intended for professional use

Package contents

• 1 test cassette in a foil pouch
• 1 sample collection container with buffer
• 1 user manual

Application

• Rapid diagnosis of Clostridium difficile infections: The test enables the qualitative detection of Clostridium difficile bacterial antigens in a stool sample, which can aid in the diagnosis of gastrointestinal infections.
• Simultaneous detection of three markers: The test detects the presence of GDH, toxin A, and toxin B—markers associated with Clostridium difficile infection.
• Support for the diagnosis of diarrhea: The product may be helpful in diagnosing patients with diarrhea, particularly when Clostridium difficile infection is suspected.
• Detection of toxin-producing strains: The detection of toxin A and toxin B aids in assessing the presence of toxin-producing bacterial strains.
• Support for medical decision-making: The test result can assist healthcare professionals in making further diagnostic or therapeutic decisions.
• Use in healthcare facilities: The product is intended for professional in vitro diagnostics and may be used in laboratories, hospitals, clinics, and diagnostic centers.

Product identification and responsible entities

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