Diagnostic test strip for collecting and detecting an analyte a fluid sample and method for using same
First Claim
1. A test strip for use in the determination of an analyte in a fluid sample, the test strip comprising:
- a base having a top and a bottom;
a collection chamber extending between the top and the bottom of the base;
a containing ring disposed on the bottom of the base, the containing ring surrounding the collection chamber;
a capillary channel formed in top of the base, the capillary channel having an inlet fluidly coupled to the collection chamber;
a test element disposed within the capillary channel; and
a lid attached to the top of the base, the lid covering the collection chamber, the test membrane, and at least a portion of the capillary channel.
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Accused Products
Abstract
A test strip for use of the determination of an analyte in a fluid sample according to one embodiment of the present invention is disclosed. The test strip comprises a base having a top and a bottom, a collection chamber that extends between the top and the bottom of the base, a containing ring that is disposed on the bottom of the base and surrounds the collection chamber, and a capillary channel formed in top of the base that has an inlet fluidly coupled to the collection chamber, a test element disposed within the capillary channel. A lid is attached to the top of the base and covers the collection chamber, the test membrane, and at least a portion of the capillary channel.
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Citations
32 Claims
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1. A test strip for use in the determination of an analyte in a fluid sample, the test strip comprising:
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a base having a top and a bottom;
a collection chamber extending between the top and the bottom of the base;
a containing ring disposed on the bottom of the base, the containing ring surrounding the collection chamber;
a capillary channel formed in top of the base, the capillary channel having an inlet fluidly coupled to the collection chamber;
a test element disposed within the capillary channel; and
a lid attached to the top of the base, the lid covering the collection chamber, the test membrane, and at least a portion of the capillary channel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A device for use in the determination of an analyte in a body fluid, the device including a lancing assembly having a lancet for puncturing the skin of a test subject, the lancet being adapted to move between a retracted position and an extended position for puncturing the skin of a test subject, the device comprising:
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an end cap removably attached to the lancing device, the end cap having a rim for contacting the skin of the test subject, the lancet extending beyond the rim of the end cap when in the extended position; and
a test strip disposed within the end cap, the test strip including a collection chamber and a capillary channel fluidly coupled to the collection chamber, the test strip including a test element disposed within the capillary channel, the test element in fluid communication with the collection chamber, the test strip including a lid disposed over the collection chamber and a least a portion of the capillary channel, the lancet puncturing the lid and extending through the collection chamber when moving between the retracted position and the extended position. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method for lancing the skin of a test subject and harvesting a body fluid sample with a lancing and harvesting device, the lancing and harvesting device having a test strip including a collection chamber, a containing ring surrounding the collection area, a capillary channel fluidly coupled to the collection area, and a lid disposed over the collection chamber and a least a portion of the capillary channel, the lancing and harvesting device having a lancet adapted to puncturing the lid and to extended through the collection chamber when moving between the retracted position and the extended position, the method comprising:
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placing the collection ring of the test strip on the skin of the test subject;
lancing an area of the skin of the test subject bounded by the periphery of the containing ring;
maintaining a body fluid sample produced at the lance site within the periphery of the containing ring;
collecting the body fluid sample produced at the lance site with the test strip; and
directing, with the lid, at least a portion of the body fluid from the collection chamber toward an inlet of the capillary channel. - View Dependent Claims (31, 32)
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Specification