Laminated assay device
First Claim
1. An assay device for performing an assay to determine an analyte in a sample, said device comprising:
- upper and lower inert supporting films fastened at their edges, said upper film having a sample port and an air vent;
positioned between said supporting films at least one bibulous sheet having a width extending substantially the full width of said films;
said bibulous sheet comprising an assay strip comprising an application zone for receiving said sample and a separation zone for seperating cells from blood, a reagent zone comprising reagents of a signal producing system for producing a colored product; and
a measurement zone comprising reagents of said signal producing system for producing a boundary whose distance along said assay strip is related to the amount of analyte in said sample, wherein at least said measurement zone extends at least a major portion of the length of said bibulous sheet and is defined by liquid impervious barriers and is of substantially narrower width than said bibulous sheet;
wherein the absorption capacity of said assay strip determines the amount of sample which is analysed.
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Accused Products
Abstract
A laminated assay device for use in determining the presence or amount of an analyte in a sample involving a bibulous assay strip having a sample application zone, a reagent zone and a pair of liquid impervious barriers defining a measurement zone extending from and in fluid communication with the application zone. The measurement zone has a volume measuring the amount of sample required for the assay. A substantially nonabsorbent first supporting film extends across and is laminated to the front surface of the assay strip, while a substantially nonabsorbent second supporting film extends across and is laminated to the back surface of the assay strip. The assay strip is impregnated with the members of a signal producing system which, upon reaction with a component in the sample, produce a detectable signal.
228 Citations
20 Claims
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1. An assay device for performing an assay to determine an analyte in a sample, said device comprising:
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upper and lower inert supporting films fastened at their edges, said upper film having a sample port and an air vent;
positioned between said supporting films at least one bibulous sheet having a width extending substantially the full width of said films;said bibulous sheet comprising an assay strip comprising an application zone for receiving said sample and a separation zone for seperating cells from blood, a reagent zone comprising reagents of a signal producing system for producing a colored product; and
a measurement zone comprising reagents of said signal producing system for producing a boundary whose distance along said assay strip is related to the amount of analyte in said sample, wherein at least said measurement zone extends at least a major portion of the length of said bibulous sheet and is defined by liquid impervious barriers and is of substantially narrower width than said bibulous sheet;wherein the absorption capacity of said assay strip determines the amount of sample which is analysed. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. An assay device for performing an assay to determine an analyte in a sample, said device comprising:
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upper and lower inert supporting films fastened at their edges, said upper film having a sample port and an air vent; positioned between said supporting films at least one bibulous sheet having a width extending substantially the full width of said films and comprising a first sample assay strip and second control assay strip; said assay strips comprising a sample application zone for receiving sample, a separation zone for separating cells from blood, a reagent zone comprising reagents of a signal producing system for producing a colored product, and a measurement zone extending at least a major portion of the length of said bibulous sheet defined by liquid impervious barriers and of a substantially narrower width than said bibulous sheet and comprising reagents of said signal producing system for producing a boundary whose distance along said assay strip is related to the amount of analyte in said sample, wherein the absorption capacity of said assay strips determines the amount of sample which is analysed and said control assay strip comprises an analyte inactivating agent and a known amount of an analyte or a substitute reagent system for producing said colored product. - View Dependent Claims (9, 10)
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11. An assay device for performing an assay to determine cholesterol in a blood sample, said device comprising:
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upper and lower inert supporting films fastened at their edges, said upper film having a sample port and an air vent; positioned between said supporting films at least one bibulous sheet having a width extending substantially the full width of said films and comprising an assay strip; said assay strip comprising a sample application zone for receiving said sample, a separation zone for separating cells from said blood, a reagent zone comprising cholesterol oxidase and cholesterol esterase, members of a signal producing system for producing a colored product, and a measurement zone extending at least a major portion of the length of said bibulous sheet defined by liquid impervious barriers and of a substantially narrower width than said bibulous sheet and comprising reagents of said signal producing system for producing a boundary whose distance along said assay strip is related to the amount of analyte in said sample, said signal producing system comprising horseradish peroxidase, an oxidizable dye coupling component and a dye coupling component non-diffusibly distributed in said measurement zone; wherein the absorption capacity of said assay strip determines the amount of sample which is analysed.
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12. A method for forming an assay device comprising the steps of:
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laminating a bibulous material to a substantially nonabsorbent first support, said bibulous material comprising a sample flow pathway having a sample application zone and a reagent zone; forming first and second liquid impervious barriers extending from said reagent zone to a distal end of said bibulous material to define a measurement zone between said liquid impervious barriers and in fluid communication with said reagent zone; and laminating a substantially absorbent second support to said bibulous material, said first support, said bibulous material and said second support comprising a laminated assembly. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20)
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Specification