The Pathogen Captures System solves the critical bottleneck of preanalytical processing in the rapid detection of pathogens in bloodstream infections. The PCS accepts a standard 10 mL green-top Vacutainer™ whole blood input which is loaded into a single-use cartridge. Upon insertion of the cartridge into the automated workstation, the clinical specimen is processed using a proprietary mixture of immunomagnetic beads that specifically and rapidly extract bacterial and fungal pathogens at concentrations as low as 1 CFU/mL. The ability to capture and concentrate low concentration pathogens in a complex matrix eliminates the need for blood culture and significantly reduces the time to detect pathogens from days to 2-3 hours, allowing a clinician to administer appropriate antibiotics at the point of need.
The unique cartridge design enables processing of the entire specimen volume. The Vacutainer™ interface collects all blood, bubble mixing facilitates pathogen/bead interaction, a unique magnetic trap captures all magnetic beads, and pathogen DNA is released through a built-in lysis module. The final output of the PCS is a volume of purified pathogen DNA that can be used for downstream ID analysis.
Proprietary Technology for Unprecedented Sensitivity and Specificity
A series of proprietary and patented technologies have been combined to provide capture and delivery of target cellular DNA from pathogens with unparalleled efficiency and sensitivity. The performance has been verified in full-scale blood spiking studies and validated in clinical specimen testing for application in the detection of bloodstream infections.
The PCS capture agents consist of proprietary magnetic beads and polyclonal antibodies. The antibody development process includes a specialized immunization strategy to induce hyperimmunity in the host animal and utilizes antigen diversity to develop specific and non-specific binding to a large and diverse panel of pathogens. Functional screening verifies the response to the pathogen panel. This development strategy produces antibodies with unparalleled sensitivity when conjugated to DNAe beads.
Critical parameters of the magnetic beads have been optimized to enable the functionality required for the PCS process in a cost-effective manner. To achieve maximum specificity by eliminating false positive signals from environmental DNA contaminants in downstream ID, DNAe has developed DNA-free manufacturing processes for all cartridge reagents and materials. These processes have been verified DNA-free through rejection challenges on all reagents and materials.
The final output of the PCS is a volume of purified pathogen DNA that can be used for downstream identification (ID) analysis
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