Calibration reagents for semiquanitative binding assays and devices
First Claim
Patent Images
1. A multizone test device for semiquantitatively determining the presence of at least a predetermined minimum concentration of an analyte in a test sample, said device comprising:
- a strip of porous material , said strip comprising a reagent zone and a capture site, said reagent zone being upstream from said capture site,a soluble conjugate comprising a labeled analyte-specific binding member which binds the analyte to form a labeled analyte complex, said soluble conjugate contained in said reagent zone,a capture reagent comprising an unlabeled specific binding member attached to said porous material, wherein said capture reagent binds the labeled analyte complex to form an immobilized labeled analyte complex, anda soluble calibration reagent comprising a n unlabeled specific binding member which blocks the binding of the analyte to said capture reagent, thereby controlling the proportion of the analyte that binds to said capture reagent such that the analyte in the test sample must exceed a minimum concentration before said immobilized labeled complex is formed, said calibration reagent contained in said reagent zone,said capture reagent being immobilized at said capture site wherein said immobilized labeled complex is separated from the test sample, and wherein the presence of label associated with said immobilized labeled complex is detected to determine the presence of at least a predetermined minimum concentration of an analyte in the test sample.
1 Assignment
0 Petitions
Accused Products
Abstract
The novel analytical devices and methods of the present invention involve a semiquantitative specific binding assay method for the detection of the presence of at least a predetermined minimum concentration of an analyte in the test sample. A calibration reagent is present at a concentration sufficient to inhibit the formation of a detectable analyte complex unless a predetermined minimum concentration of analyte is present in the test sample.
78 Citations
9 Claims
-
1. A multizone test device for semiquantitatively determining the presence of at least a predetermined minimum concentration of an analyte in a test sample, said device comprising:
-
a strip of porous material , said strip comprising a reagent zone and a capture site, said reagent zone being upstream from said capture site, a soluble conjugate comprising a labeled analyte-specific binding member which binds the analyte to form a labeled analyte complex, said soluble conjugate contained in said reagent zone, a capture reagent comprising an unlabeled specific binding member attached to said porous material, wherein said capture reagent binds the labeled analyte complex to form an immobilized labeled analyte complex, and a soluble calibration reagent comprising a n unlabeled specific binding member which blocks the binding of the analyte to said capture reagent, thereby controlling the proportion of the analyte that binds to said capture reagent such that the analyte in the test sample must exceed a minimum concentration before said immobilized labeled complex is formed, said calibration reagent contained in said reagent zone, said capture reagent being immobilized at said capture site wherein said immobilized labeled complex is separated from the test sample, and wherein the presence of label associated with said immobilized labeled complex is detected to determine the presence of at least a predetermined minimum concentration of an analyte in the test sample. - View Dependent Claims (2, 3, 4, 5, 6, 7)
-
-
8. A multizone test device for semiquantitatively determining the presence of at least a predetermined minimum concentration of an analyte in a test sample, said device comprising:
-
a strip of porous material, said strip comprising a reagent zone and a capture site, said reagent zone being upstream from said capture site, a soluble conjugate comprising a labeled analyte-specific binding member which binds the analyte to form a labeled analyte complex, said soluble conjugate contained in said reagent zone, a capture reagent comprising a n unlabeled specific binding member attached to said porous material, wherein said capture reagent binds the labeled analyte complex to form an immobilized labeled analyte complex, and a soluble calibration reagent comprising an unlabeled specific binding member which blocks the binding of the analyte to said conjugate, thereby controlling the proportion of said labeled analyte complex that binds to said capture reagent such that the analyte in the test sample must exceed a minimum concentration before said immobilized labeled complex is formed, said calibration reagent contained in said reagent zone, said capture reagent being immobilized at said capture site wherein said immobilized labeled complex is separated from the test sample, and wherein the presence of label associated with said immobilized labeled complex is detected to determine the presence of at least a predetermined minimum concentration of an analyte in the test sample. - View Dependent Claims (9)
-
Specification