Rapid In Vitro Diagnostic Sensor to Detect and Identify Interferon- alpha in Patient Fluid Samples

At this time it is very difficult to distinguish viral infections from bacterial infections. Published results suggest that some subtypes of interferon-alpha (INF-a) are present in viral infections and are not detected in bacterial infections but no clinically useful assay for this potential marker for acute viral infections exits at this time. The government and the private sector has a strong need for a diagnostic device that can rapidly identify INF-a in patient fluids. The specific objective in Phase I is to develop specific, sensitive, and reliable electro-immunosensors that permit rapid on-site testing for viral infections by detecting INF-a in patient fluids. The proposed electro- immunosensor consists of two major elements: a solid-phase membrane layer having immobilized enzyme, antibody and other necessary reagents, and the electronic monitor used in the readout of the signal. The expected result is a novel electro-immunosensor that will quantitatively detect 0 - 100 IU INF-a/mL patient fluids in 1 user step in <5 minutes, based on the principle of coupling the immunochemical reaction to the electrode response. The researchers submitting this proposal have collaborated successfully to develop prototype electrochemical enzyme immunoassay sensors in the past. Practical electrochemical sensors that employ immunoassay detection have broad commercial applications in in vitro diagnostics and environmental monitoring.