Dual glucose-turbidimetric analytical sensors
First Claim
Patent Images
1. :
- A dry reagent diagnostic device for the simultaneous analysis of two or more different analytes in a single application of a single sample of whole blood with a volume under 20 μ
l, wherein the first analyte is determined by a first detection zone, and a second detection zone, physically separated from the first detection zone, determines the second analyte;
a fluid bridge formed by the applied sample connects the two detection zones;
said first detection zone and second detection zone having materials and geometry selected to allow simultaneous activation of both zones by a single unseparated whole blood drop;
said detection zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood;
said detection zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood;
said detectable sample application signal being capable of triggering an automated detection zone reader which is capable of performing subsequent test timing in an automated manner;
and at least one of the detection zones produces a detectable change in an optical signal.
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Abstract
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.
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Citations
20 Claims
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1. :
- A dry reagent diagnostic device for the simultaneous analysis of two or more different analytes in a single application of a single sample of whole blood with a volume under 20 μ
l,wherein the first analyte is determined by a first detection zone, and a second detection zone, physically separated from the first detection zone, determines the second analyte;
a fluid bridge formed by the applied sample connects the two detection zones;
said first detection zone and second detection zone having materials and geometry selected to allow simultaneous activation of both zones by a single unseparated whole blood drop;
said detection zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood;
said detection zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood;
said detectable sample application signal being capable of triggering an automated detection zone reader which is capable of performing subsequent test timing in an automated manner;
and at least one of the detection zones produces a detectable change in an optical signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- A dry reagent diagnostic device for the simultaneous analysis of two or more different analytes in a single application of a single sample of whole blood with a volume under 20 μ
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12. :
- A system for determining the relative concentration of a postprandial lipemia analyte from a single application of a single sample of whole blood;
said system comprising a disposable test strip for receiving said sample of whole blood, and an electronic meter;
said electronic meter having a microprocessor, microprocessor program, visual display, illumination means capable of illuminating said test strip with light with wavelengths greater than about 650 nm, and photodetector means capable of detecting light returned from said test strip;
said test strip containing optically transmissive materials, said optically transmissive materials capable of transmitting light from said light source to said sample of whole blood, and returning scattered light from said sample of whole blood to said photodetector;
said photodetector producing a scattered light signal that is conveyed to said microprocessor;
said microprocessor program containing an algorithm that converts said scattered light signal into a measurement of a postprandial lipemia analyte concentration;
wherein said meter visual display displays said measurement of said postprandial lipemia analyte concentration. - View Dependent Claims (13, 14, 15)
- A system for determining the relative concentration of a postprandial lipemia analyte from a single application of a single sample of whole blood;
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16. :
- 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;
adding said blood sample to a dry reagent diagnostic device in a single application, said dry reagent diagnostic device containing at least two detection zones;
wherein a first analyte in said sample is determined by a first detection zone, and a second detection zone, physically separated from the first detection zone, determines a second analyte in said sample;
forming a fluid bridge with the applied blood sample to connect all detection zones on said device;
said first detection zone and second detection zone having detection zone materials and geometry being selected to allow simultaneous activation of all zones by a single unseparated whole blood drop;
said detection 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 detection zones by a detectable change in an optical signal. - View Dependent Claims (17, 18, 19, 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;
Specification