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