Intended use:
RIDA®QUICK Clostridium difficile GDH is an immunochromatographic rapid test for the qualitative detection of Clostridium difficile-specific glutamate dehydrogenase (GDH) in 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 RIDA®QUICK Clostridium difficile GDH immunochromatographic rapid test 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 RIDA®QUICK Clostridium difficile GDH difficile rapid test improves the reliability of detection of this very consequential nosocomial pathogen when performed sequentially, i.e., before or parallel to the RIDA®QUICK Clostridium difficile Toxin A/B rapid test. 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.
Accessories:
| Art. No. | N0703 |
|---|---|
| Test format | lateral flow rapid test 25 determinations |
| Incubation time | 15 mins |
| Detection limit | 0,5 ng/ml GDH protein |
| Sensitivity | 100% |
| Specificity | 95% |
| Positive predictive value | 96,7% |
| Negative predictive value | 100% |
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.
