Intended use:

RIDASCREEN® Clostridium difficile GDH is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of Clostridium difficile-specific glutamate dehydrogenase (GDH) in human stool specimens.

General information:

Clostridioides (Clostridium) difficle infection (CDI) is the most common cause of nosocomial and antibiotic-associated diarrhea. CDI can develop after disturbance of the gut microbiome by the administration of antibiotics, chemotherapeutic agents, immunosuppressants or proton pump inhibitors, as well as by inflammatory bowel diseases or surgical interventions on the digestive tract. Symptoms of the disease include watery diarrhea with a characteristic foul smell, abdominal pain, fever, leukocytosis, and hypoalbuminemia. Severe cases can result in ileus, pseudomembranous colitis (PMC), toxic megacolon, intestinal perforation, or sepsis.

The growing frequency and severity of CDI leads to rising healthcare expenses, and increased morbidity and mortality. The implementation of multistage diagnostic testing algorithms has improved overall diagnostic accuracy. In line with that, the testing algorithms recommend initial screening for C. diffcile-specific glutamate dehydrogenase (GDH).

Diagnostic capabilities of the RIDASCREEN® Clostridium difficile GDH

  • Reliable screening for C. difficile with very high analytical sensitivity
  • Monoclonal antibodies for specific detection
  • Reduction of patient contact isolation time and cost savings through GDH screening(1)

Accessories:

Single Components:

(1) Vogelzang, E.H., Lankelma, J.M., van Mansfeld, R. et al. Implementing a Clostridium difficile testing algorithm and its effect on isolation duration and treatment initiation: a pre- and post-implementation study. Eur J Clin Microbiol Infect Dis 2020: 39, 1071–1076.
Specifications
Art. No. C0701
Test format ELISA consisting of 96 tests
Files

Dear customers,

we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.

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