Test carrier for determining an analyte in a blood sample, process for making the carrier and use thereof
First Claim
1. Test carrier for determination of an analyte in a whole blood sample comprising a two sided erythrocyte separation means, a first side of said erythrocyte separation means being in fluid communication with a means for the application of blood and a second side of said erythrocyte separation means being in fluid communication with an evaluation means, said erythrocyte separation means comprising an integral composite structure having a first zone, a second zone and a transition region between said first and second zones, said first zone containing a polymeric film former, kieselguhr and a pigment, said first zone having applied thereon said second zone containing a liquid coated polymeric film former thereby forming said transition region of said integral composite structure between said first and second zones, said first zone of said erythrocyte separation means facing said first side and said second zone of said erythrocyte separation means facing said second side.
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Abstract
The present invention provides a test carrier for the determination of an analyte from whole blood with the help of reagents contained in the test carrier, said test carrier having a blood application side to which blood is applied, an evaluation side on which, as a result of the reaction of the reagents with the analyte, an optically detectable change takes place, and an erythrocyte separation means between the blood application side and the evaluation side, wherein the erythrocyte separation means includes an integral composite having a first zone, which contains a polymeric film former, kieselguhr and a pigment, and thereupon, with formation of a transition region, a second zone containing a polymeric film-former, formed by liquid coating the first zone facing the blood application side and the second zone facing the evaluation side of the integral composite. The present invention also provides a process for the production of this test carrier and a method for analyzing blood samples using it.
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Citations
16 Claims
- 1. Test carrier for determination of an analyte in a whole blood sample comprising a two sided erythrocyte separation means, a first side of said erythrocyte separation means being in fluid communication with a means for the application of blood and a second side of said erythrocyte separation means being in fluid communication with an evaluation means, said erythrocyte separation means comprising an integral composite structure having a first zone, a second zone and a transition region between said first and second zones, said first zone containing a polymeric film former, kieselguhr and a pigment, said first zone having applied thereon said second zone containing a liquid coated polymeric film former thereby forming said transition region of said integral composite structure between said first and second zones, said first zone of said erythrocyte separation means facing said first side and said second zone of said erythrocyte separation means facing said second side.
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10. Process for producing a test carrier for determining an analyte in a sample of whole blood, comprising:
forming a first zone of an integral composite structure by applying a first flowable coating mass to a substrate base, said first coating mass containing a solution or dispersion of a polymeric film former in a carrier liquid, kieselguhr, a pigment and an adjuvant and drying said first coating mass to form a first zone on said substrate base, applying a second coating mass containing a solution or dispersion of a polymeric film former to said film to form a second zone, said first zone and second zone forming an integral composite structure with a transition region formed therebetween, and positioning said laminated composite structure in a test carrier such that the first zone is in fluid communication with a blood application means of said carrier and the second zone is in fluid communication with an evaluation means of said test carrier. - View Dependent Claims (11, 12, 13, 14, 15)
Specification