PrimeraDx out of Mansfield, MA received the CE Marking for its ICEPlex real time multiplex PCR system and the accompanying C. difficile assay.
According to the company, the ICEPlex is capable of throughput of “96 samples and reporting on up to 60 targets per sample in 2.5 hours.” To guarantee accuracy and relieve lab techs from doing separate runs, calibrators and standards are added to each sample and are run in the same wells.
System components from the product page:
- High Pressure Gel Fluidic System monitoring pressure during fill
- Peltier-based 96 well Thermal Cycler with a removal plate clamping mechanism
- Robotics module in X, Y and Z translation
- Low Pressure fluidic system for reagent replenishment
- Disposable Compact capillary electrophoresis module with on-cartridge storage of information and use history
- Solid State Laser for excitation
- Hyperspectral imaging cooled CCD camera (122 x 1024 pixels)
- Capillary temperature regulating system
- System data, sensors and monitors, and recording system
Press release: PrimeraDx Receives CE Marks for the ICEPlex System and C. difficile Detection Assay
Product page: ICEPlex System