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) in a predetermined distance 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.
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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.
68 Citations
36 Claims
- 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) in a predetermined distance 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.
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26. A method for preparing an analyte test element comprising the steps:
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applying areas of high and low surface energy on a base layer (2) having a first surface (2a), the areas of high surface energy forming a hydrophilic path with a predetermined detection areas (6′
a), whereby n is an integer number equal or larger than 2,applying a corresponding pattern of areas of high and low surface energy on a cover layer (4) having a second surface (4a), coating a catalytic formulation on the .n detection areas (6′
a) of the first surface (2a), said catalytic formulation promoting the detection of an analyte concentration contained in a physiological or aqueous fluid sample using transmission or absorbance photometry,coating n calibration formulations on n detection areas, (6a) of the second surface (4a), said n calibration formulations made up of m blank formulations and n−
m formulations with different levels of calibration compound, whereby m is an integer number of at least 1, and n>
m, which is identical or substantially equivalent to the analyte and able to induce the same chemical reaction in the catalytic formulation as the analyte in the physiological or aqueous fluid sample,laminating the layers of first and second surfaces to the opposite sites of a centre layer (3) having a discontinuity (5) which provides a cavity for the sample distribution system (6) formed by the areas of high surface energy on the first and second surfaces of the base and cover layer, punching or cutting the laminated sheets to the final shape. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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35. A method for determining the concentration of at least one analyte in a physiological or aqueous sample, said method comprising
applying a physiological or aqueous sample to an analyte test element having a first surface (2a) and a second surface (4a) in a predetermined distance 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, wherein the applied physiological or aqueous fluid is constrained to the areas with high surface energy, detecting the signals produced in the different detection areas, and relating the signals to determine the amount of the analyte(s) in the physiological or aqueous sample.
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36. 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 in a predetermined distance 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.
Specification