Assay device, composition, and method of optimizing assay sensitivity
First Claim
1. An assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample, the composition comprising:
- a support matrix pervious to optical radiation;
a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample, the support matrix having at least one detection zone for detecting the physical change, the detection zone having a cross-sectional area and a depth profile extending into the support matrix;
an opacifier present in an amount sufficient to increase the resolution of the physically detectable change, the opacifier being distributed uniformly across the cross-sectional area of the detection zone and being distributed through at least a portion of the depth profile of the support matrix within the detection zone, the chemical reagent being substantially immobilized relative to the opacifier when detecting the physical change.
2 Assignments
0 Petitions
Accused Products
Abstract
The present invention provides an assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample. The composition includes a support matrix pervious to optical radiation and a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample. The support matrix has at least one detection zone for detecting the physical change with a cross-sectional area and depth profile. The composition includes an opacifier present in an amount sufficient to increase the resolution of the physically detectable change. The opacifier is distributed uniformly across the cross-sectional area of the detection zone and is distributed through at least a portion of the depth profile of the support matrix within the detection zone. The chemical reagent is substantially immobilized relative to the opacifier when detecting the physical change. The assay composition can be supported on a transport matrix and used in an assay device. The present invention determines the level of a selected analyte in a sample by optimizing a physically detectable change in an assay composition which correlates with the amount of selected analyte when contacted with the sample. The present invention optimizes the assay results of a selected analyte in a sample-exposed assay composition by increasing the reflection of optical radiation detecting a physical change of the sample-exposed assay composition to be within the range of optimal assay resolution.
-
Citations
51 Claims
-
1. An assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample, the composition comprising:
-
a support matrix pervious to optical radiation;
a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample, the support matrix having at least one detection zone for detecting the physical change, the detection zone having a cross-sectional area and a depth profile extending into the support matrix;
an opacifier present in an amount sufficient to increase the resolution of the physically detectable change, the opacifier being distributed uniformly across the cross-sectional area of the detection zone and being distributed through at least a portion of the depth profile of the support matrix within the detection zone, the chemical reagent being substantially immobilized relative to the opacifier when detecting the physical change. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
-
-
14. A transport matrix producing a physically detectable change in a detection zone which correlates with the amount of selected analyte in a sample, the matrix comprising:
-
a detection zone having a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample, the detection zone having a cross-sectional area and a depth profile extending into the matrix;
an opacifier present in an amount sufficient to increase the resolution of detecting the physical change, the opacifier being distributed uniformly across the cross-sectional area of the detection zone and being distributed through at least a portion of the depth profile of the matrix within the detection zone, the opacifier being substantially immobilized relative to the chemical reagent in the detection zone when detecting the physical change. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
-
-
27. A diagnostic device for determining the presence of a selected analyte in a sample, the device comprising:
-
a housing having an exterior surface and sealing an interior area;
a receptor configured to receive the sample containing an analyte selected for determining its presence, the receptor being located on the exterior surface of the housing;
at least one transport matrix for reacting the sample with a chemical reagent to yield a physically detectable change in a detection zone which correlates with the amount of selected analyte in the sample, the detection zone having a cross-sectional area and a depth profile extending into the matrix, an opacifier present in an amount sufficient to increase the resolution of detecting the physical change, the opacifier being distributed uniformly across the cross-sectional area of the detection zone and distributed through at least a portion of the depth profile of the matrix within the detection zone, the opacifier being substantially immobilized relative to the chemical reagent in the detection zone when detecting the physical change. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35)
-
-
36. A method for determining the level of a selected analyte in a sample, the method comprising the step of:
optimizing a physically detectable change in an assay composition which correlates with the amount of selected analyte when contacted with the sample. - View Dependent Claims (37, 38, 39, 40, 41, 42)
-
43. A method of optimizing the assay results of a selected analyte in a sample-exposed assay composition, the method comprises:
increasing the reflection of optical radiation detecting a physical change of the sample-exposed assay composition to be within the range of optimal assay resolution. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51)
Specification