Integrated assay device and housing
First Claim
Patent Images
1. A laminated analyte assay device, comprising:
- a support strip andan overlamina in contact with the support strip, wherein said overlamina is embossed to form one or more recesses between the support strip and the overlamina, and the support strip and overlamina are bonded together at surfaces other than said recesses;
an assay strip comprising at least one reagent for detecting an analyte present in a sample, the assay strip positioned in one of said one or more recesses, for fluid communication with a sample opening in the overlamina for receiving the sample,wherein the overlamina is embossed to form a well or recess at said sample opening, and further includes a separate viewing opening, for viewing at least a portion of the assay strip, andthe well or recess being sized to hold a preselected volume of a sample, where the preselected volume of sample is sufficient to saturate the assay strip without over-filling the recess that the assay strip is positioned in.
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Abstract
A laminated, integrated, analyte assay device and methods of using the device are described. The assay device is useful as an inexpensive, disposable assay device for detecting the presence and/or amount of a particular analyte in a body fluid or other sample.
94 Citations
16 Claims
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1. A laminated analyte assay device, comprising:
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a support strip and an overlamina in contact with the support strip, wherein said overlamina is embossed to form one or more recesses between the support strip and the overlamina, and the support strip and overlamina are bonded together at surfaces other than said recesses; an assay strip comprising at least one reagent for detecting an analyte present in a sample, the assay strip positioned in one of said one or more recesses, for fluid communication with a sample opening in the overlamina for receiving the sample, wherein the overlamina is embossed to form a well or recess at said sample opening, and further includes a separate viewing opening, for viewing at least a portion of the assay strip, and the well or recess being sized to hold a preselected volume of a sample, where the preselected volume of sample is sufficient to saturate the assay strip without over-filling the recess that the assay strip is positioned in. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for detecting the presence or absence of an analyte in a sample, comprising:
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providing a laminated analyte assay device comprising; (i) a support strip, (ii) an overlamina in contact with the support strip, wherein said overlamina is embossed to form one or more recesses between the support strip and the overlamina, and the support strip and overlamina are bonded together at surfaces other than said recesses; (iii) an assay strip comprising at least one reagent for detecting an analyte present in a sample, the assay strip positioned in one of said one or more recesses, for fluid communication with a sample opening in the overlamina for receiving the sample, (iv) wherein the overlamina is embossed to form a well or recess at said sample opening, and further includes a separate viewing opening, for viewing at least a portion of the assay strip, and (v) the well or recess being sized to hold a preselected volume for receipt of a sample of a preselected volume, where the preselected volume of sample is sufficient to saturate the assay strip without over-filling the recess that the assay strip is positioned in, and introducing a sample to fill the well or recess at the sample opening in the overlamina, whereupon the sample contacts the at least one reagent for detecting an analyte on the assay strip. - View Dependent Claims (16)
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Specification