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..
