Diagnostic test carrier with multilayer field
First Claim
1. A diagnostic test carrier for the determination of an analyte from a whole blood sample, comprisinga reagent system;
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wherein the test field comprises a transparent foil, a first film layer applied to the top of the foil and a second film layer applied to the top of the first film layer so that the two film layers are fixedly attached one over the other in direct intimate contact with each other;
wherein the transparent foil has a foil side and a non-foil side, and the foil side is the detection side of the test field and the first film layer is applied to the non-foil side;
wherein when in a wet state the first film layer scatters light less than the second film layer scatters light;
wherein the test field is constructed such that erythrocytes present in the sample substantially do not reach the detection side of the test field; and
wherein the first film layer and second film layer are formed from (a) a dispersion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous dispersion, or (b) an emulsion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous emulsion, wherein the swelling capability of the swelling agent is at a level which allows the optically detectable change to be measured on the detection side after a maximum of one minute.
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Abstract
The present invention concerns a diagnostic test carrier for the determination of an analyte from whole blood with the aid of a reagent system contained in the carrier which includes a colour forming reagent with a test field which has a sample application side onto which the blood sample is applied and a detection side on which an optically detectable change takes place as a result of the reaction of analyte with the reagent system and which is constructed in such a way that erythrocytes present in the sample do not reach the detection side, which is characterized in that the test field comprises a transparent foil onto which a first and a second film layer are applied on top of one another and wherein the first layer located on the transparent foil scatters light considerably less in a wet state than the overlying second layer and wherein the side of the foil on which the first layer is applied which is opposite to the foil side is the detection side and the side of the second layer which is opposite to the side with which the second layer rests on the first is the sample application side. In addition the invention concerns a method for the determination of an analyte from whole blood with the aid of a diagnostic test carrier according to the invention.
244 Citations
27 Claims
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1. A diagnostic test carrier for the determination of an analyte from a whole blood sample, comprising
a reagent system; - and
a test field, containing said reagent system, wherein the test field has a sample application side onto which a whole blood sample is applied, and a detection side which produces an optically detectable signal when the analyte reacts with the reagent system; wherein the test field comprises a transparent foil, a first film layer applied to the top of the foil and a second film layer applied to the top of the first film layer so that the two film layers are fixedly attached one over the other in direct intimate contact with each other; wherein the transparent foil has a foil side and a non-foil side, and the foil side is the detection side of the test field and the first film layer is applied to the non-foil side; wherein when in a wet state the first film layer scatters light less than the second film layer scatters light; wherein the test field is constructed such that erythrocytes present in the sample substantially do not reach the detection side of the test field; and wherein the first film layer and second film layer are formed from (a) a dispersion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous dispersion, or (b) an emulsion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous emulsion, wherein the swelling capability of the swelling agent is at a level which allows the optically detectable change to be measured on the detection side after a maximum of one minute. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A diagnostic test carrier for the determination of an analyte from a whole blood sample, comprising
a test field having a reagent system therein, wherein the test field has a sample application side onto which a whole blood sample is applied, and a detection side which produces an optically detectable signal when the analyte reacts with the reagent system, wherein the test field is constructed such that erythrocytes present in the sample do not reach the detection side of the test field, and wherein the test field comprises a transparent foil, a first film layer applied to the top of the foil and a second film layer applied to the top of the first film layer so that the two film layers are fixedly attached one over the other in direct intimate contact with each other, wherein the first film layer and the second film layer are both formed from (a) a dispersion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous dispersion, or (b) an emulsion of a polymeric film former which contains the polymeric film former and a swelling agent in a homogeneous emulsion, wherein the swelling capability of the swelling agent is at a level which allows the optically detectable change to be measured on the detection side after a maximum of one minute, wherein the transparent foil has a foil side and a non-foil side, and the foil side comprises the detection side of the test field, wherein the first film layer is applied to the non-foil side, and wherein the first film layer scatters light less in a wet state than the second film layer scatters light; -
a supporting layer to which the detection side of the test field is attached; a network which covers the sample application side of the test field, extends beyond the test field, and is attached to the supporting layer beyond the test field by means of spacers; and a cover arranged over the areas of the network which extend beyond the test field and slightly cover the area of the test field on each side in such a way that a sample application site is substantially not covered by the cover in the region of the network that covers the test field; wherein the network defines a capillary gap between the cover and the test field and the cover and the supporting layer, such that capillary liquid transport is possible for the removal of excess sample when the test field is saturated with liquid. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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Specification