One-Step Sample Extraction Cassette And Method For Point-Of-Care Molecular Testing
US-2024207853-A1 · Jun 27, 2024 · US
US9586204B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9586204-B2 |
| Application number | US-201514799832-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jul 15, 2015 |
| Priority date | Jun 23, 2014 |
| Publication date | Mar 7, 2017 |
| Grant date | Mar 7, 2017 |
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The present disclosure proposes a design of a biomedical paper sensor which can determine the concentration of biological materials in fluids such as blood, urine, and saliva. The sensor contains a plurality of axially radiating test zones, each test zone separated from other test zones by wax ink barriers formed by a process that produces thin walls. Each test zone can contain a unique test reagent, or a unique concentration of a test reagent, and can also be identified by printed text. The region of the device outside of the test zone area is printed with a uniform reference color. Benefits of the invention include increased accuracy in the measurement of the concentration of biological materials due to the larger test zone area. Benefits also include the integration of the reference or calibration color which simplifies the calibration needed for quantification of the concentration.
Opening claim text (preview).
What is claimed is: 1. A biomedical paper sensor for determining a concentration of biological materials in fluids comprising: a plurality of axial symmetric test zones; wherein the test zones radiate outward from a central point; each of the axial symmetric test zones divided by wax ink barrier walls; each of the axial symmetric test zones contain a unique test reagent therein; a reference region surrounding the plurality of axial test zones; and, wherein the reference region includes a plurality of calibration color sub-areas including a distinct predeterminable color for each sub-area to compare to each one of the associated plurality of the axial test zones. 2. The paper sensor of claim 1 , wherein the plurality of test zones is at least two. 3. The paper sensor of claim 1 , further comprising: a total device area including the combined areas of a reference region area and the axial test zones area; and, wherein the axial test zones area is at least 37.5% of the total device area. 4. The paper sensor of claim 3 , wherein the reference region area further includes a substrate region separating the axial test zones area and the calibration color area. 5. The paper sensor of claim 1 , wherein an area of each of the axial symmetric test zones is at least 5 mm 2 . 6. The paper sensor of claim 1 , wherein the wax ink barrier walls include a thickness of about 100 μm. 7. The paper sensor of claim 1 , further comprising: a plasma separation membrane layer. 8. The paper sensor of claim 7 , wherein said plasma separation layer includes a series of pores on a top surface and a bottom surface; and, said series of pores have a pore size gradient between said top surface and said bottom surface. 9. The paper sensor of claim 8 , wherein said pore size on said top surface is greater than said pore size on said bottom surface. 10. A biomedical paper sensor for determining a concentration of biological materials in fluids comprising: a plurality of axially radiating test zones; each of the axially radiating test zones divided by wax ink barrier walls; each of the axially radiating test zones contain a unique concentration of a test reagent therein; a reference region surrounding the plurality of axially radiating test zones; wherein the reference region includes a calibration color area including a predeterminable color for comparing to each one of the plurality of axially radiating test zones; and, wherein each one of the plurality of axially radiating test zones display a gradient of color change due to the unique concentration of a test reagent therein for a single analyte assay determination. 11. The paper sensor of claim 10 , further comprising: a total device area including the combined areas of a reference region area and the axially radiating test zones area; and, wherein the axially radiating test zones area is at least 37.5% of the total device area. 12. The paper sensor of claim 11 , wherein the reference region area further includes a substrate region separating the axially radiating test zones area and the calibration color area. 13. The paper sensor of claim 10 , wherein an area of each of the axially radiating test zones is at least 5 mm 2 . 14. The paper sensor of claim 10 , wherein the wax ink barrier walls include a thickness of about 100 μm. 15. A biomedical paper sensor for determining a concentration of biological materials in fluids comprising: a plurality of axially radiating test zones; each of the axially radiating test zones divided by wax ink barrier walls; each of the axially radiating test zones contain a unique test reagent therein; a reference region surrounding the plurality of axially radiating test zones; a total device area including the combined areas of a reference region area and the axially radiating test zones area; wherein the axially radiating test zones area is at least 37.5% of the total device area; wherein the reference region area further includes a substrate region separating the axially radiating test zones area and a calibration color area; and, the calibration color area including a predeterminable color for comparing to each one of the plurality of axially radiating test zones. 16. The paper sensor of claim 15 , wherein an area of each of the axially radiating test zones is at least 5 mm 2 . 17. The paper sensor of claim 15 , wherein the wax ink barrier walls include a thickness of about 100 μm.
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