Intended use:

For in vitro diagnostic use. The RIDASCREEN® Verotoxin test is an enzyme immunoassay for the qualitative detection of verotoxins (Shiga-like toxins I and II) from a stool samples enrichment in mTSB broth.

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 isolation of the pathogen from the enrichment broth.

Accessories:

Single Components:

Specifications
Art. No. C2201
Test format Microtiter plate with 96 wells (12 strips with 8 removable wells each)
Incubation time 105 min
Detection limit for verotoxin 1: 12,5 pg/ml
for verotoxin 2: 25,0 pg/ml
Sensitivity Positive correlation to two different commercial ELISA tests (samples from enrichment cultures)
93.9 %
Specificity Negative correlation to two different Commercial ELISA tests (samples from enrichment cultures)
96.1 %
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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