Analyte test system using non-enzymatic analyte recognition elements
First Claim
1. An analyte test element for the qualitative and/or quantitative determination 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, whereby the areas of high surface energy create a sample distribution system (6) with at least two detection areas (6a, 6′
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a), wherein at least one of the detection areas (6a, 6′
a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32).
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Abstract
An analyte test element for the qualitative and/or quantitative determination 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, whereby the areas of high surface energy (6, 6′) create a sample distribution system with at least two detection areas (6a, 6′a), said at least one of the detection areas (6a, 6′a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32). The analyte test element is suitable for analyte test systems evaluating the affinity reaction between an analyte of interest and a recognition element and therefore provides a suitable test system to perform immunoassays, receptor-assays, or other affinity assays with a simple test element containing qualitative or quantitative calibration mechanisms suitable for point of care and home settings.
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Citations
29 Claims
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1. An analyte test element for the qualitative and/or quantitative determination 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, whereby the areas of high surface energy create a sample distribution system (6) with at least two detection areas (6a, 6′
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a), wherein at least one of the detection areas (6a, 6′
a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 22, 23, 24, 25, 29)
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a), wherein at least one of the detection areas (6a, 6′
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16. A method for preparing an analyte test element comprising the steps:
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generating 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 sample distribution system (6) with n predetermined detection areas (6′
a), whereby n is an integer number larger than 2,generating a corresponding pattern of areas of high and low surface energy on a cover layer (4) having a second surface (4a), coating n predetermined detection areas (6a) of the first surface (2a) with n calibration formulations (18) made up of m blank formulations and n-m formulations containing different levels of a calibration compound (33), whereby n is an integer number larger than 2, m is an integer number equal or larger than 1, and n>
m, andcoating n predetermined detection areas (6′
a) of the second surface (4a) with a recognition formulation (19) containing a recognition element (32),applying 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 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 (17, 18, 19, 20, 21, 28)
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26. A method for the qualitative and/or quantitative determination of at least one analyte in a physiological or aqueous sample fluid, said method comprising applying a physiological sample fluid 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 (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), wherein detection areas (6a, 6′
a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32),connecting the analyte test element to a detection and processing means, detecting and relating the signals produced in the different detection areas.
- ) forming areas of high surface energy which are aligned mostly congruent to create a sample distribution system with at least two detection areas (6a), wherein detection areas (6a, 6′
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27. 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 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, wherein detection areas of the first and second surfaces is provided with at least one specific non-enzymatic analyte recognition element.
Specification