Diagnostic assay requiring a small sample of biological fluid
First Claim
1. An article for determining the presence or amount of analyte in a biological sample, said article comprising a multiple-layer element comprising:
- (a) a base layer having two major surfaces, said base layer further having an opening, a flow channel, and an optical reading chamber, one end of which flow channel communicates with said opening in said base layer and the other end of which flow channel communicates with said optical reading chamber; and
(b) a cover layer in face-to-face contact with the major surface of said base layer containing said opening, said cover layer having an opening therein to vent said element.
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Reexamination
Accused Products
Abstract
An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a preferred embodiment, the element comprises:
(a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of the two major surfaces to a second opening in the other of the two major surfaces, the core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber;
(b) a base layer in face-to-face contact with one major surface of the core layer; and
(c) a cover layer in face-to-face contact with the other major surface of the core layer, the cover layer having an opening therein to vent the element.
In another aspect, the invention involves a method comprising the steps of:
(a) obtaining a sample of biological fluid, e.g., interstitial fluid, from the body of a patient;
(b) introducing the sample to an article comprising a multiple-layer element having an optical reading chamber;
(c) allowing reagents to react with an analyte of interest in the sample; and
(d) measuring the concentration of analyte in the sample by means of an optical instrument.
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Citations
34 Claims
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1. An article for determining the presence or amount of analyte in a biological sample, said article comprising a multiple-layer element comprising:
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(a) a base layer having two major surfaces, said base layer further having an opening, a flow channel, and an optical reading chamber, one end of which flow channel communicates with said opening in said base layer and the other end of which flow channel communicates with said optical reading chamber; and (b) a cover layer in face-to-face contact with the major surface of said base layer containing said opening, said cover layer having an opening therein to vent said element. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 25, 26, 27, 28, 29)
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13. An article for determining the presence or amount of analyte in a biological sample, said article comprising a multiple-layer element comprising;
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(a) a core layer having two major surfaces, said core layer further having an opening, a flow channel, and an optical reading chamber, one end of which flow channel communicates with said opening in said core layer and the other end of which flow channel communicates with said optical reading chamber; and (b) a base layer in face-to-face contact with one major surface of said core layer; and (c) a cover layer in face-to-face contact with the other major surface of said core layer, said cover layer having an opening therein to vent said element. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 30, 31, 32, 33, 34)
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Specification