Intended use:
For in vitro diagnostic use. The RIDA®QUICK Verotoxin / O157 Combi test is a immunochromatographic rapid test for the qualitative determination of Verotoxins (syn. Shiga toxins) and of Escherichia coli serotype O157 in enrichment cultures.
General information:
Enterobacteriaceae of the species E. coli are a normal part of the intestinal flora of humans as well as of many farm animals. E. coli can be viewed as facultative pathogenic through different, often plasmid-coded pathogenicity factors or pathogenicity factors transferred through phages. This includes, in particular, enterohemorrhagic E. coli (EHEC), which was identified in 1977 and is the primary cause of severe illnesses such as hemorrhagic colitis (HC) and hemolytic uremic syndrome (HUS). They are capable of producing two cytotoxins (Verotoxin 1 and 2). A multitude of other serotypes that can cause severe illnesses besides the O157 prototype have been described since then. Therefore, every STEC should be considered to be a potential EHEC.
The current recommended approach in the diagnostic testing of STEC/EHEC is overnight incubation in mTSB broth containing Mitomycin C as an inductor for the formation of shigatoxins with the subsequent immunological detection of the shigatoxins as well as the shigatoxingens and the isolation of the pathogene from the enrichment broth.
The RIDA®QUICK Verotoxin / O157 Combi rapid assay enables the extremely specific and simultaneous detection of shigatoxins and the highly virulent Serotype O157 within 20 minutes from the supernatant of the enrichment broth (e.g. RIDA® Anreicherungsbouillon ; Z1003 ; 25 tubes).
Highlights:
- Antigen detection from an enrichment culture using a fast assay
- Unique assay combination for the simultaneous detection of verotoxins and/or E. coli O157
- An innovative technology enables the color-differentiated detection of both pathogens
- Sensitive detection of all humanpathogenic strains of Shiga toxin/Verotoxin-producing organisms
- Specific capturing of all E. coli O157 strains (sorbitol-fermenting and non-sorbitol-fermenting)
Accessories:
| Art. No. | N2203 |
|---|---|
| Test format | 20 cassettes |
| Incubation time | The test result can be read off after 15 minutes. |
| Detection limit | Stx 1: 2 ng/ml Stx 2: 0.5 ng/ml |
| Sensitivity | for Stx 1 / Stx 2: 85.0 % for O157: 90.9 % |
| Specificity | for Stx 1 / Stx 2: 98.7 % for O157: 98.5 |
| Additional information | Positive controls are available as separate accessories for the corresponding RIDA®QUICK rapid assays. |
| Instructions | |
|---|---|
| SDS |
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.
