Intended use:
For in vitro diagnostic use. RIDA®GENE Dientamoeba fragilis is a multiplex real-time PCR for the direct, qualitative detection of Dientamoeba fragilis from human stool samples.
The RIDA®GENE Dientamoeba fragilis multiplex real-time PCR is intended for use as an aid in diagnosis of gastrointestinal infection caused by Dientamoeba fragilis.
General information:
Dientamoeba fragilis is one of the most important diarrhea-causing protozoa and is distributed worldwide. Recent studies demonstrated the pathogenic potential and implicated it as a common cause of gastrointestinal disease. Infection with D. fragilis may be either symptomatic or asymptomatic. Symptoms of dientamoebiasis are abdominal pain and diarrhea. The prevalence of D. fragilis varies from 0.3 % to 52 % and often exceeds that of Giardia lamblia.
Classically, diagnosis of Dientamoeba fragilis is achieved by microscopial examination of faecal samples, which require experienced personal. RIDA®GENE Dientamoeba fragilis real-time PCR is a new and attractive alternative method for testing stool samples and has proven to be highly sensitive and specific for the detection of Dientamoeba fragilis.
| Art. No. | PG1745 |
|---|---|
| Test format | real-time PCR with 100 reactions |
| Shelf life | 24 months after production |
| Sensitivity | Analytical Sensitivity: > 5 DNA copies per reaction |
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.
