Coagulation test system
First Claim
1. A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being 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 one detection area (6a), wherein the detection area(s) (6a, 6′
- a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent.
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Accused Products
Abstract
A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being 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 one detection area (6a), wherein the detection area(s) (6a, 6′a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent. The coagulation test element is provided with an integrated quality control system suitable for dry reagent test strip format with a very small sample volume of about 0.5 μL. The production of the inventive coagulation test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the element.
60 Citations
23 Claims
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1. A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being 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 one detection area (6a), wherein the detection area(s) (6a, 6′
- a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 19, 20)
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12. A method for preparing a coagulation 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 at least one predetermined detection area (6a), generating a corresponding pattern of areas of high and low surface energy on a cover layer (4) having a second surface (4a), coating the predetermined detection area(s) (6a) of the first surface (2a) and/or second surface 4a with at least one coagulation stimulation reagent, 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 (6) formed by the areas of high surface energy on the first and second surfaces (2a, 4a) of the first and second layer (2, 4). - View Dependent Claims (13, 14, 15, 16, 17, 18, 22, 23)
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21. A coagulation test element for determining the coagulation in a serum or whole blood 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 one detection area, wherein the detection area(s) of the first and second surfaces is/are provided with at least one coagulation stimulation reagent.
Specification