While routine point-of-care blood chemistry measurements can now be performed in clinical settings, quantitative high-sensitivity immunoassay measurements cannot. Thus, low-level serum markers for a variety of life-threatening conditions, such as sepsis, cannot be performed at the point of care. IA Inc.'s immunosensors possess the requisite speed and sensitivity needed to bring immunoassay to the point-of- care (POC), but lack the internal calibration and multiplexing features needed for measuring a panel of markers with the inter-sensor reproducibility required for clinical assays. The goal of this project is to extend IA, Inc's biosensor technology from the research environment into clinical settings by developing a self-calibrating, multi-analyte biosensor system which rapidly and accurately measures panels of low concentration disease markers in serum. The technology platform will be adaptable for rapid measurement of any blood analyte that currently requires more time-consuming immunoassay procedures. This project will focus on developing the two features that must be added to the existing technology platform in order to provide a point-of-care panel: self-calibration of sensors and multi-analyte capability. Phase II will provide a panel of inflammatory markers, such as cytokines, which are useful for diagnosis of life-threatening conditions such as sepsis and heart failure. By improving the speed with which clinical staff can make diagnosis, earlier treatment will reduce patient morbidity and mortality as well as the high cost incurred by more advanced disease progression. The Phase I Specific Aims include: 1) Develop inter-sensor calibration methods for data normalization; 2) Develop an instrument to measure 4-6 fluorescent emissions; 3) Perform calibrated simultaneous assay of 2 analytes; 4) Evaluate a universal sensor surface for use in antibody-based assays. The use of quantum dots for achieving calibration and multiplexing will be explored. ? ? ?
