SBIR-STTR Award

The objective of this SBIR project is to develop a new, solid state immunosensor with capabilities for use in homes, farms, factories and offices for on-site quantitative determination of hormones, drugs and toxins in biological fluids such as plasma, saliva, and urine. The principle of detection will be based on an enzyme- amplified, immunoelectrochemical solid state detector that can be coupled to different reporter-amplifier systems and modified to accommodate an array of sensors for different compounds. During Phase I, we intend to demonstrate the feasibility of developing the sensor and to determine if it will be able to give expected sensitive and quantitative measurements. Phase II research will focus on optimizing the sensor, introducing the capability for measuring multiple different substances simultaneously at multiple sites on a single probe, incorporating the probe into an easily-used device that obviates the need for pipetting and sample manipulation, and coupling the probe to instrumentation able to be used in the field. Results of this project will provide the basis for developing a system that is extremely easy to use, requiring little manipulation and no pipetting. The envisioned system will eliminate the need for subjective estimation of quantities, will avoid errors, and will be able to be used to estimate concentrations of multiple different hormones, drugs or other agents simultaneously in biological fluids by untrained personnel.

The objective of this SBIR research is to develop a new, generic, immunoelectrochemical sensor system with capabilities for rapid, on-site, quantitative determination of biologically important molecules in fluids such as blood, plasma, serum, saliva, and urine. The principle is based on an enzyme-amplified, immunoelectrochemical, solid phase detector that can be coupled to different reporter-amplifier systems. Feasibility was demonstrated in Phase I. When complete, a user should only need to inject a sample into an analyte-specific, disposal cartridge and insert it into an analytical module. After a few minutes the measured concentration will be displayed. Phase II research will focus on optimizing the system; developing an easily-used instrument that obviates the need for pipetting; and developing and testing prototype systems able to attract Phase III support for commercialization. Specificity will be achieved through use of discriminating anti-analyte monoclonal antibodies and sensitivity through enzyme amplification and amperometric detection of generated reaction products. The developed sensor will feature low cost, electrode stability (negligible fouling),l one-step operation, and point of use calibration. If the sensor system functions as we anticipate, the capability of the sensor could be extended to the detection and quantitation of a wide variety of agents including environmental toxins, infectious agents, antibodies, drugs of abuse, diagnostic biomolecules and therapeutic drugs