Patents


Patent 6,984,307
Dual-mode electrochemical-optical diagnostic dry reagent tests capable of reacting with a single drop of whole blood and reporting both glucose and other analytes (such as lipids or beta-hydroxybutyrate) are taught. Such dual-mode dry reagent tests achieve higher functionality by combining both electrochemical detection methodologies and optical detection into a single test-strip. These dual-mode tests are simple and low-cost enough to be used on a routine basis, and help facilitate management of diabetes complications, such as diabetic ketoacidosis.

"20. A method for determining the concentration of two or more analytes in a single sample of whole blood with a volume under 20 ul, comprising the steps of; applying said blood sample to a dry reagent diagnostic device in a single application, said dry reagent diagnostic device containing at least two reaction zones; wherein a first analyte in said sample is determined by a first reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines a second analyte in said sample; forming a fluid bridge with the applied blood sample to connect; all reaction zones on said device; said first reaction zone and second reaction zone having reaction zone materials and geometry; and selected to allow simultaneous rehydration and activation of all zones by a single unseparated whole blood drop; said reaction zone materials and geometry being selected as to return detectable analyte signals in the presence of whole blood; and determining the concentration of at least one of said analytes from at least one of said reaction zones by a detectable change in an optical signal."

"21. The method of claim 20, in which at least one analyte produces an electrochemical signal, and in which at least one analyte produces a detectible change in an optical signal."


 


Patent 7,758,744
Diagnostic dry reagent tests capable of reacting with a single drop of whole blood and reporting both glucose and light-scattering analytes, such as chylomicrons, are taught. Such dry reagent tests may employ electrochemical detection methodologies, optical detection methodologies, or both methodologies. These tests alert diabetics to excessive levels of postprandial lipemia caused by meals with excessive amounts of fat, and thus can help reduce the risk of cardiovascular complications in diabetic patients (CIP of 6,984,307).


Patent 7,166,208
The invention discloses methods by which dry reagent enzyme based electrochemical biosensors, which are in a relatively mature form due to the extensive amount of development pioneered by the blood glucose monitoring industry, may be simply adapted to perform tests for blood coagulation, enzymatic activity, or immunochemical assays for antigens present in a fluid sample. In particular, the utility of combining apoenzyme based dry reagent electrochemical biosensors with apoenzyme reactivation technology is taught. This combination creates a novel combination dry reagent test technology capable of detecting a wide range of different analytes.

"6. A method for detecting an antigen in a liquid sample, said method comprising: an electrode containing an apoenzyme or otherwise inactive form of an electrochemically active enzyme that, in the active form, would produce an electrochemical change in said electrode in response to an enzyme substrate to die electrically active enzyme; an apoenzyme cofactor, prosthetic group or other activation moiety that converts the inactive form of said electrochemically active enzyme to an active form: said cofactor, prosthetic group or activation moiety being present in the form of a complex that changes its structure due to interactions with said antigen; said complex additionally containing an antibody capable of binding to said antigen; said complex being incapable of activating the apoenzyme or otherwise inactive form of the electrochemically active enzyme in the absence of said antigen; wherein said analyte induces changes in said complex, enabling said cofactor, prosthetic group or said activation moiety to activate said apoenzyme or said inactive form of an electrochemically active enzyme: resulting in a detectable electrochemical change in said electrode; in which antigen is added to the electrode, the electrochemical status of the electrode is assessed, and the relative amount of antigen present in the sample is detected."



Pending Patent 11/656,089
The invention discloses a device and method by which dry reagent enzyme based electrochemical biosensors, which are in a relatively mature form due to the extensive amount of development pioneered by the blood glucose monitoring industry, may be simply adapted to perform tests for blood coagulation, enzymatic activity, or immunochemical assays for antigens present in a fluid sample. In particular, the utility of combining apoenzyme based dry reagent electrochemical biosensors with apoenzyme reactivation technology is taught. This combination creates a novel combination test technology capable of detecting a wide range of different analytes, and operating in a wide variety of wet or dry, in vivo or in vitro environments..


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