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:

Glutamate dehydrogenase (GDH), an enzyme present in high copy numbers in many organisms, has proved to be a sensitive screening marker for Clostridium difficile. Since GDH is present in many intestinal bacteria, it is crucial that assay systems for glutamate dehydrogenase be accurate and highly sensitive for the detection of C. difficile-specific GDH. The RIDASCREEN® Clostridium difficile GDH enzyme-linked immunosorbent assay (ELISA) meets both of these requirements to a high degree. Although it does not eliminate the need for the detection of C. difficile toxins A and B, which is obligatory for the diagnosis of Clostridium difficile infection, the RIDASCREEN® Clostridium difficile GDH ELISA improves the reliability of detection of this very consequential nosocomial pathogen when performed sequentially, i.e., before or parallel to the RIDASCREEN® Clostridium difficile Toxin A/B ELISA. Both the specific clinical symptoms and signs and the positive detection of C. difficile toxins A and B are required for diagnosis and adequate treatment decision-making in cases of suspected CDI.

Specifications
Art. No. C0701
Test format Microtiter plate with 96 wells (12 strips with 8 removable wells each)
Incubation time 105 min
Sensitivity 90,9 % (compared to PCR)
Specificity 99,2 % (compared to PCR)
Positive predictive value 96,8 %
Negative predictive value 97,6 %
Additional information Detection limit : 0,3 ng/ml
Files
InstructionsGerman
English
French
Italian
Spain
Portuguese
SDSC0701_english.zip (English)
C0701_german.zip (German)
C0701_french.zip (French)
C0701_italian.zip (Italian)
C0701_spanish.zip (Spanish)
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