IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
UP-0871673
(2004-06-18)
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등록번호 |
US-7727467
(2010-06-22)
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발명자
/ 주소 |
- Burke, David W.
- Marquant, Michael
- Zapf, Udo
- Fritz, Michael
- Mosoiu, Dan
- Wilsey, Chris
|
출원인 / 주소 |
- Roche Diagnostics Operations, Inc.
- Roche Operations, Ltd.
|
대리인 / 주소 |
Woodard, Emhardt, Moriarty, McNett & Henry LLP
|
인용정보 |
피인용 횟수 :
36 인용 특허 :
278 |
초록
▼
A test strip having a small sample-receiving chamber on the order of less than 1 microliter. The inventive test strip includes a reagent layer that extends across the width of the test strip and also extends to the sample-receiving end, such that the edges of the reagent layer are aligned with the s
A test strip having a small sample-receiving chamber on the order of less than 1 microliter. The inventive test strip includes a reagent layer that extends across the width of the test strip and also extends to the sample-receiving end, such that the edges of the reagent layer are aligned with the side and dose receiving edges of the test strip. The hydrophilic reagent extending to the dosing edge of the strip promotes wicking of the sample into the test strip. The end and side edges of the reagent layer are preferably formed as part of a cutting process that forms individual test strips from a larger web, which results in a smooth and thin reagent layer with a uniform thickness, substantially covering the entire floor of the sample-receiving chamber. The inventive mass production process helps improve the reproducibility of the quantity, location, thickness and other properties of the reagent layer, which in turn improves the accuracy of the test result.
대표청구항
▼
What is claimed is: 1. A test strip, comprising: a base substrate having a working electrode and a counter electrode formed thereon and having two opposite side edges and an end edge; a spacing layer overlying the base substrate and having a void that at least partially defines a sample-receiving c
What is claimed is: 1. A test strip, comprising: a base substrate having a working electrode and a counter electrode formed thereon and having two opposite side edges and an end edge; a spacing layer overlying the base substrate and having a void that at least partially defines a sample-receiving chamber; a covering layer overlying the spacing layer; and a reagent layer disposed in the sample-receiving chamber and covering a portion of the base substrate and at least one of the electrodes, the reagent layer extending under the spacing layer to the two side edges of the base substrate and being sandwiched between the spacing layer and the base substrate. 2. The test strip of claim 1, wherein the reagent layer extends to the end edge of the base substrate. 3. The test strip of claim 2, wherein the reagent layer defines a reagent layer end edge that is aligned with the end edge of the base substrate. 4. The test strip of claim 2, wherein a sample-receiving opening of the sample-receiving chamber is disposed at the end edge of the base substrate. 5. The test strip of claim 1, wherein the reagent layer defines two reagent layer side edges that are aligned with the side edges of the test strip. 6. The test strip of claim 1, wherein the spacing layer comprises a unitary spacing layer. 7. The test strip of claim 1, wherein the spacing layer comprises an adhesive material. 8. The test strip of claim 1, further comprising an adhesive layer disposed between the spacing layer and the base substrate. 9. The test strip of claim 8, wherein the adhesive layer is sandwiched between the spacing layer and the base substrate, the adhesive layer having an edge profile that is aligned with a peripheral edge of the sample-receiving chamber. 10. The test strip of claim 9, wherein the adhesive layer forms a seal around the periphery of the sample-receiving chamber. 11. The test strip of claim 1, wherein the test strip defines a central longitudinal axis and the sample-receiving chamber forms a channel oriented substantially parallel to the central longitudinal axis. 12. The test strip of claim 11, wherein the covering layer comprises a vent opening in communication with the sample-receiving chamber, the vent opening being positioned over a downstream portion of the sample-receiving chamber. 13. The test strip of claim 12, wherein the reagent layer extends to the downstream portion of the sample-receiving chamber over which the vent opening is positioned. 14. The test strip of claim 13, wherein the reagent layer extends beyond the downstream portion of the sample-receiving chamber over which the vent opening is positioned. 15. The test strip of claim 1, wherein the reagent layer has a thickness of between about 1 and 20 microns. 16. The test strip, of claim 15, wherein the reagent layer has a thickness of between about 2 and 6 microns. 17. The test strip of claim 1, wherein the sample-receiving chamber has a height from about 50 μm to about 200 μm. 18. The test strip of claim 17, wherein the sample-receiving chamber has a height from about 120 μm to about 180 μm. 19. The test strip of claim 1, wherein the sample-receiving chamber has a volume of less than 1.0 μl. 20. The test strip of claim 1, wherein the sample-receiving chamber has a volume of less than 0.5 μl. 21. The test strip of claim 1, wherein the sample-receiving chamber has a volume from about 0.15 μl to about 1.4 μl. 22. The test strip of claim 21, wherein the sample-receiving chamber has a volume from about 0.4 μl to about 0.7 μl. 23. The test strip of claim 1, wherein the reagent layer has a uniform thickness, substantially devoid of a meniscus. 24. The test strip of claim 1, wherein the reagent layer includes one or more thickeners, viscosity modulators, film formers, stabilizers, buffers, detergents, gelling agents, fillers, film opening agents, coloring agents, and thixotropic agents. 25. The test strip of claim 1, wherein the reagent layer includes silica. 26. A test strip, comprising: a test strip body having meter-insertion and sample-receiving ends, first and second side edges, and a central longitudinal axis disposed substantially parallel to the two opposite side edges, the test strip body defining a downstream direction from the sample-receiving end to the meter-insertion end; a base substrate defining the bottom of the test strip body and having an electrode formed thereon, the base substrate having edges aligned with the sample-receiving end and the first and second side edges of the test strip body; a spacing layer overlying the base substrate and having a void that at least partially defines a sample-receiving chamber; and a reagent layer disposed in the sample-receiving chamber and covering a portion of the base substrate and the electrode, the reagent layer being sandwiched between the spacing layer and the base substrate and extending to the first and second side edges of the base substrate and the sample-receiving end of the test strip body; and a covering layer overlying the spacing layer, the covering layer comprising a vent opening in communication with the sample-receiving chamber, the vent opening aligned with the sample-receiving chamber at a location downstream of the sample-receiving opening. 27. The test strip of claim 26, wherein the sample-receiving chamber defines a channel aligned with the longitudinal axis, the channel terminating at a sample-receiving opening disposed at the sample-receiving end, whereby the reagent layer extends to the sample-receiving opening. 28. The test strip of claim 26, wherein the vent opening comprises a slot formed in the covering layer. 29. The test strip of claim 26, wherein the reagent layer extends in the downstream direction to the vent opening. 30. The test strip of claim 29, wherein the reagent layer extends in the downstream direction beyond the vent opening. 31. The test strip of claim 29, wherein the reagent layer extends in the downstream direction beyond the electrode. 32. The test strip of claim 31, wherein the electrode comprises a counter electrode and a working electrode. 33. The test strip of claim 26, wherein the spacing layer comprises a unitary spacing layer. 34. The test strip of claim 26, further comprising an adhesive layer disposed between the spacing layer and the base substrate. 35. The test strip of claim 34, wherein the adhesive layer is sandwiched between the spacing layer and the base substrate, the adhesive layer having an edge profile that is aligned with a peripheral edge of the sample-receiving chamber. 36. The test strip of claim 35, wherein the adhesive layer forms a seal around the periphery of the sample-receiving chamber. 37. The test strip of claim 26, wherein the reagent layer has a thickness of between about 1 and 20 microns. 38. The test strip of claim 37, wherein the reagent layer has a thickness of between about 2 and 6 microns. 39. The test strip of claim 26, wherein the reagent layer includes silica.
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