Analyte test system for determining the concentration of an analyte in a physiological or aqueous fluid
First Claim
1. An analyte test element for determining the concentration of at least one analyte in a physiological or aqueous sample fluid having a first surface (2a) and a second surface (4a) opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent to create a sample distribution system (6) with at least two detection areas (6a), wherein the applied physiological or aqueous fluid is substantially constrained to the areas with high surface energy, and wherein n predetermined detection areas (6′
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a) of said first surface (2a) are coated with a catalytic formulation promoting the detection of an analyte in a physiological or aqueous fluid, and n predetermined detection areas (6a) of said second surface (4a) are coated with n calibration formulations made up of m blank formulations and n-m formulations with different levels of calibration compound, whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
m.
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Accused Products
Abstract
This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 μL based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.
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Citations
25 Claims
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1. An analyte test element for determining the concentration of at least one analyte in a physiological or aqueous sample fluid having a first surface (2a) and a second surface (4a) opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent to create a sample distribution system (6) with at least two detection areas (6a), wherein the applied physiological or aqueous fluid is substantially constrained to the areas with high surface energy, and wherein n predetermined detection areas (6′
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a) of said first surface (2a) are coated with a catalytic formulation promoting the detection of an analyte in a physiological or aqueous fluid, and n predetermined detection areas (6a) of said second surface (4a) are coated with n calibration formulations made up of m blank formulations and n-m formulations with different levels of calibration compound, whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
m. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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a) of said first surface (2a) are coated with a catalytic formulation promoting the detection of an analyte in a physiological or aqueous fluid, and n predetermined detection areas (6a) of said second surface (4a) are coated with n calibration formulations made up of m blank formulations and n-m formulations with different levels of calibration compound, whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
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25. An analyte test element for determining the concentration of at least one analyte in a physiological or aqueous sample fluid having a first surface and a second surface opposite from each other, wherein one of the first and second surface is provided with a hydrophilic/hydrophobic pattern and the corresponding surface provides a homogeneous pattern of hydrophilic pixels surrounded by a hydrophobic area therefore creating overall a surface with semi hydrophilic and semi hydrophobic character, whereby the hydrophilic and semi hydrophilic areas create a sample distribution system with at least two detection areas and wherein n predetermined detection areas (6′
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a) of said first surface (2a) are coated with a catalytic formulation promoting the detection of an analyte in a physiological or aqueous fluid, and n predetermined detection areas (6a) of said second surface (4a) are coated with n calibration formulations made up of m blank formulations and n-m formulations with different levels of calibration compound, whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
m.
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a) of said first surface (2a) are coated with a catalytic formulation promoting the detection of an analyte in a physiological or aqueous fluid, and n predetermined detection areas (6a) of said second surface (4a) are coated with n calibration formulations made up of m blank formulations and n-m formulations with different levels of calibration compound, whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
Specification