Hospital acquired infections (HAI)

ERBA Molecular has developed a C. difficile test as an example of how its technology can be applied to the detection and identification of organisms associated with HAI.  This test also demonstrates more broadly the utility of ERBA molecular’s technology and approach to clinical diagnostics and is part of a pipeline of enteric tests being developed.

ERBA Molecular's C. difficile assay is an integrated sample preparation system and in vitro diagnostic test combined, for the direct detection of Clostridium difficile in human stool samples in patients suspected of having C. difficile -Associated Disease (CDAD).

The LAMP-BART method showed 95.5% sensitivity and 100% specificity against a gold standard reference method using cytotoxigenic culture and also a silica-based robotic extraction followed by PCR to control for storage. From sample to result, the LAMP-BART method typically took 35 minutes to detect a positive, whereas the PCR method took over 2.5 hours.

 

Simplifying work flow - three steps from sample to result

Heat Elution steps

Benefits

  • Simple
    • One step sample prep
    • Single reagent transfer
  • Robust
    • Non specialist users can run the test
    • Does not need to be performed in a specialist lab
  • Easy to use
    • Simple workflow with sample-in, result-out, with a single transfer step.
    • Positive sample readout
      in < 30 mins
    • Highly scalable platform from 1 to 96 samples in a single run on a single instrument
If you are interested in discussing development opportunities for this application please [click here]

Step 1

 

 

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Step 2

 

 

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Step 3

 

 

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Above is a photographic illustration of the steps of the LAMP-BART that underlines the simplicity of the process and ease-of-use.

 

Future potential menu

ERBA Molecular envisages that a panel of rapid. Simple and robust molecular tests for either HAI or enteric infection could include but not limited to:

1.MRSA
2. Noro virus
3. H pylori

4. Salmonella
5. Campylobacter
6. E coli 0157