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Microbial testing for infectious disease, food safety, quality control and biothreat has grown rapidly and has recently moved from culture methods to molecular methods. Typically, researchers and clinicians are interested in 10s of pathogens, and increasingly they want a quantitative answer.
Using the ICEPlex system, researchers can very easily assay 10s of pathogens all in one well, from one swab and receive a quantitative answer. PrimeraDx has begun a clinical trial for 510(k) clearance of an IVD for detection of the most prevalent hospital acquired infection, C. difficile.
We have performed numerous experiments to demonstrate the capabilities of the ICEPlex System in pathogen detection applications. In one such experiment, we showed that we can simultaneously detect and quantify the levels of seven pathogens (two bacteria, two yeasts and three viruses). Internal Control (TYE labeled) to monitor PCR inhibition was used along with three dual labeled calibrators (FAM and TYE) for peak assignment and sizing using one common primer pair. These results demonstrate that the ICEPlex can quantitatively analyze seven separate pathogens from one sample in the same well.