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 first and second surfaces are provided with two substantially equivalent patterns, forming areas of high and low surface energy, which are aligned most congruent, whereby the areas of high surface energy (6, 6′
- ) create a sample distribution system with at least two detection areas (6a, 6′
a), characterized in that the detection areas (6a) of the first surface (2a) are provided with working electrodes (8a) and the detection areas (6′
a) of the second surface (4a) are provided with corresponding reference electrodes (8′
a) of electrochemical detection means.
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Abstract
An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface 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, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.
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Citations
26 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) in a predetermined distance opposite from each other, said first and second surfaces are provided with two substantially equivalent patterns, forming areas of high and low surface energy, which are aligned most congruent, whereby the areas of high surface energy (6, 6′
- ) create a sample distribution system with at least two detection areas (6a, 6′
a), characterized in that the detection areas (6a) of the first surface (2a) are provided with working electrodes (8a) and the detection areas (6′
a) of the second surface (4a) are provided with corresponding reference electrodes (8′
a) of electrochemical detection means. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 23)
- ) create a sample distribution system with at least two detection areas (6a, 6′
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17. A method for preparing an analyte test element comprising the steps:
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applying a pattern of working electrodes (8) on a first layer (2) having a first surface (2a), applying a corresponding pattern of reference electrodes (8′
) on a second layer (4) having a second surface (4a),generating areas of high and low surface energy on the first surface (2a), generating corresponding pattern of areas of high and low surface energy on the second surface (4a), the areas of high surface energy (6, 6′
) forming a hydrophilic sample distribution system with n predetermined detection areas (6a, 6′
a), whereby n is an integer number larger than 2, whereby the working and reference electrodes (8, 8′
) are located underneath a predetermined detection areas (6, 6′
) of the hydrophilic sample distribution system,coating a catalytic formulation on then detection areas (6a) of the first surface, said catalytic formulation promoting the detection of an analyte concentration contained in a physiological fluid sample using electrochemical detection means, coating n calibration formulations on n detection areas (6′
a) of the second surface, 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 fluid sample,applying the layers of first and second surfaces to the opposite sites of a center layer (3) having a discontinuity (5), which provides a cavity for the sample distribution system formed by the areas of high surface energy (6, 6′
) on the first and second surfaces (2a, 4a) of the first and second layer (2, 4). - View Dependent Claims (18, 19, 20, 21, 22, 26)
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24. A method for determining the concentration of at least one analyte in a physiological or aqueous sample, said method comprising:
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connecting an analyte test element to a detection and processing means, applying a physiological 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 tow substantially equivalent patterns (6, 6′
) forming areas of high surface energy which are aligned mostly congruent to create a sample distribution system with at least two detection areas (6a) each of them overlaying a working electrode (8), and at least two detection areas (6′
a), each of them overlaying a reference electrode (8′
a),detecting the signals produced in the different detection areas, and relating the signals to determine the amount of the analyte(s) in the physiological sample.
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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 in a predetermined distance opposite from each other, wherein one of the first and second surface is provided with a hydrophilic or hydrophobic pattern and the corresponding surface provides a homogeneous pattern of hydrophilic pixels surrounded by a hydrophobic area therefore creating 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, said detection areas of the first surface are provided with working electrodes and the detection areas of the second surface are provided with corresponding reference electrodes (8′
- a) of electrochemical detection means.
Specification