IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0888990
(2010-09-23)
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등록번호 |
US-8142721
(2012-03-27)
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발명자
/ 주소 |
- Burke, David W.
- Marquant, Michael
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출원인 / 주소 |
- Roche Diagnostics Operations, Inc.
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대리인 / 주소 |
Woodard, Emhardt, Moriarty, McNett & Henry LLP
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인용정보 |
피인용 횟수 :
0 인용 특허 :
281 |
초록
▼
A test strip with a covering layer having a novel slot. The slot divides the inventive covering layer into two parts and provides a vent opening that allows air to escape as fluid enters a cavity or sample receiving chamber formed in the test strip. In preferred embodiments, the covering layer is cl
A test strip with a covering layer having a novel slot. The slot divides the inventive covering layer into two parts and provides a vent opening that allows air to escape as fluid enters a cavity or sample receiving chamber formed in the test strip. In preferred embodiments, the covering layer is clear such that the user can see through it and the slot doubles as a “fill line.” The user can thus watch the fluid sample enter the test strip, progress through the capillary cavity, and then stop at the slot or fill-line. This provides positive assurance to the user that the sample size is sufficient and the test strip has been filled properly. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.
대표청구항
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1. A test strip, comprising: a base substrate having electrodes formed thereon;a reagent layer overlying a portion of the base substrate;a spacing layer overlying at least the reagent layer;a chamber cover overlying a first portion of the spacing layer;a body cover overlying a second portion of the
1. A test strip, comprising: a base substrate having electrodes formed thereon;a reagent layer overlying a portion of the base substrate;a spacing layer overlying at least the reagent layer;a chamber cover overlying a first portion of the spacing layer;a body cover overlying a second portion of the spacing layer, the chamber cover and the body cover having a slot therebetween;wherein the spacing layer has a void that defines a sample receiving chamber between the base substrate and the chamber cover, wherein the slot is in communication with the sample receiving chamber, the slot defining a vent opening between the chamber cover and the body cover that allows air to escape as fluid enters the sample receiving chamber; andwherein the reagent layer is disposed in the sample receiving chamber and covering at least one of the electrodes and extends under the spacing layer and is sandwiched between the spacing layer and the base substrate. 2. The test strip of claim 1, wherein the slot is substantially aligned with an interior end of the sample receiving chamber. 3. The test strip of claim 1, wherein one surface of the spacing layer is adhered to the base substrate and an opposite surface of the spacing layer is adhered to the chamber cover. 4. The test strip of claim 1, wherein the chamber cover comprises a hydrophilic surface adjacent the sample receiving chamber. 5. The test strip of claim 1, wherein the reagent layer extends across the width of the test strip. 6. The test strip of claim 1, wherein the reagent layer substantially covers the bottom of the sample receiving chamber. 7. The test strip of claim 1, wherein the slot is positioned over the reagent layer. 8. The test strip of claim 1, wherein the sample receiving chamber is bounded on the top side thereof by the chamber cover and the underside of the chamber cover is hydrophilic, whereby wicking of sample fluid into the sample receiving chamber is promoted. 9. The test strip of claim 1, wherein the slot comprises a gap that extends between the body cover and the chamber cover and separates the body cover from the chamber cover, the body cover and the chamber cover having substantially straight edges proximate the gap. 10. The test strip of claim 9, wherein the gap is oriented substantially perpendicular to a longitudinal axis of the test strip. 11. The test strip of claim 1, wherein the sample receiving chamber communicates with a fluid receiving opening disposed at an edge of the test strip. 12. The test strip of claim 1, wherein the body cover includes a hydrophobic portion adjacent the slot. 13. The test strip of claim 1, wherein the body cover is adhered to the spacing layer with a hydrophobic adhesive. 14. The test strip of claim 1, wherein the body cover and chamber cover are formed from the same material. 15. The test strip of claim 14, wherein the body cover is treated with a hydrophobic substance and the chamber cover is treated with a hydrophilic substance. 16. The test strip of claim 1, further comprising electrode traces extending from the electrodes along the base substrate and terminating in contact pads at a meter insertion end of the test strip, the contact pads being exposed for electrical connection thereto. 17. The test strip of claim 1, wherein the chamber cover overlies substantially the entire length of the sample receiving chamber. 18. The test strip of claim 17, wherein the chamber cover has about the same length as the sample receiving chamber. 19. The test strip of claim 17, wherein the chamber cover is transparent or translucent above the sample receiving chamber, whereby fluid entering the sample receiving chamber is visible through the chamber cover. 20. The test strip of claim 18, wherein a top surface of the spacing layer adjacent the void and the bottom of the sample receiving chamber have contrasting colors and are visible through the chamber cover. 21. The test strip of claim 1, wherein the base substrate, spacing layer and chamber cover are adhered to one another by one of heat welding, laser welding, heat sensitive adhesives, pressure sensitive adhesives and combinations thereof 22. The test strip of claim 1, wherein the electrodes are disposed in the sample receiving chamber. 23. The test strip of claim 1, wherein the body cover and chamber cover are aligned end to end and are disposed in substantially the same horizontal plane.
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