Infectious Disease

Combat Infectious Disease with
Rapid and Accurate Detection

In recent years, infectious diseases have become more prevalent, more severe, and more difficult to treat. 

Pathogen Detection

Microbial testing has recently moved from cell culture methods to molecular diagnostic methods. Typically, researchers and clinicians are interested in testing for many pathogens at the same time, and increasingly, they want a quantitative answer.

Using the ICEPlex System, researchers can very easily assay multiple pathogens in the same sample, and receive a qualitative or quantitative answer depending on the application. Clinical labs use the ICEPlex System to develop tests (LDTs) for detection of infectious agents.  

Clostridium difficile assay

C. difficile is the most commonly acquired healthcare-associated infections (HAIs). According to the CDC, while most types of HAIs are declining, one—caused by the germ C. difficile—remains at historically high levels. C. difficile causes diarrhea linked to 14,000 American deaths each year. Rapid and accurate detection is critical.

PrimeraDx has developed ICEPlex C. difficile assay on PrimeraDx’s multi-modal and multiplex innovative platform. PrimeraDx is conducting a controlled multi-site clinical trial for ICEPlex C. difficile assay on ICEPlex System to offer the accuracy of real-time PCR with the time and cost savings of multiplex technology.

The ICEPlex C. difficile assay on ICEPlex System is under a clinical trial for investigation use only, and the performance characteristics of ICEPlex C. difficile assay of have not been established.

Other Assays in Development

  • Fungal Panel (direct blood detection)
  • Transplant Panel (multiple viral loads)
  • STI Panel (yeast, virus, bacteria, parasites)
  • Respiratory Panel (pathogens including drug-resistant strains)
  • Food Pathogen
  • Pharma QC

We have performed numerous experiments to demonstrate the capabilities of the ICEPlex System in pathogen detection applications such as identification of variant strains and drug resistant pathogens. 

In one such experiment, using our STI panel, we showed that we can simultaneously detect and discriminate seven pathogens (two bacteria, two yeasts, two viruses and one parasite.) Three dual-labeled calibrators (FAM and TYE) were used for peak assignment and sizing and an Internal Control (TYE labeled) was used to monitor PCR inhibition. These results demonstrate that the ICEPlex can quantitatively analyze seven separate pathogens from one sample in the same well. 

Learn more about applications that PrimeraDx’s multiplex PCR technology supports.