Laminated assay device
AssigneeChemtrak, Inc.
InventorMichael P. Allen
Life of this patent
Estimating the term…
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.
Claims20
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.
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 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.
An assay device for performing an assay to determine cholesterol in a blood 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 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.
A method for forming an assay device comprising the steps of:
- 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.
Dependencies are inferred from the claim text.