Assay method using internal calibration to measure the amount of analyte in a sample
First Claim
1. An assay for determining the amount of a test analyte contained in a sample, comprising the following sequential steps:
- (a) providing a mixture of a known volume of said sample and a known amount of a calibrator analyte, wherein said calibrator analyte is foreign to said sample and the behavior of said calibrator analyte is comparable to that of said test analyte under the same assay conditions;
(b) contacting said mixture with a solid support, wherein said solid support comprises a first reagent capable of selectively binding said test analyte bound to a first discrete area of said solid support and a second reagent capable of selectively binding said calibrator analyte bound to a second discrete area of said solid support;
(c) contacting said solid support with a first labelled substance capable of selectively binding said test analyte and a second labelled substance capable of selectively binding said calibrator analyte, wherein said first and second labelled substances use an identical label; and
(d) determining the amount of said test analyte in said sample by comparing the level of said first labelled substance bound to said test analyte and of said second labelled substance bound to said calibrator analyte.
1 Assignment
0 Petitions
Accused Products
Abstract
This invention relates to a method of determining the amount of test analyte in a sample using internal calibration comprising mixing a sample with a predetermined amount of a calibrator analyte foreign to the sample and with a comparable behavior in an assay to that of the test analyte, contacting the mixture with a solid support containing, each in a separate area, a regent for binding the test and calibrator analytes, respectively, contacting the solid support with a mixture of labelled reagents for binding the test and calibrator analytes, respectively, and determining the amount of test analyte in the sample by comparing the levels of labelled reagent bound to the test and calibrator analytes.
67 Citations
55 Claims
-
1. An assay for determining the amount of a test analyte contained in a sample, comprising the following sequential steps:
-
(a) providing a mixture of a known volume of said sample and a known amount of a calibrator analyte, wherein said calibrator analyte is foreign to said sample and the behavior of said calibrator analyte is comparable to that of said test analyte under the same assay conditions; (b) contacting said mixture with a solid support, wherein said solid support comprises a first reagent capable of selectively binding said test analyte bound to a first discrete area of said solid support and a second reagent capable of selectively binding said calibrator analyte bound to a second discrete area of said solid support; (c) contacting said solid support with a first labelled substance capable of selectively binding said test analyte and a second labelled substance capable of selectively binding said calibrator analyte, wherein said first and second labelled substances use an identical label; and (d) determining the amount of said test analyte in said sample by comparing the level of said first labelled substance bound to said test analyte and of said second labelled substance bound to said calibrator analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
-
-
33. A test kit for determining the amount of a test analyte in a sample, comprising
(a) a first container comprising a known amount of a calibrator analyte, wherein said calibrator analyte is foreign to said sample and the behavior of said calibrator analyte is comparable to that of said test analyte under the same assay conditions; -
(b) a solid support comprising a first reagent capable of selectively binding said test analyte bound to a first discrete area of said solid support and a second reagent capable of selectively binding said calibrator analyte bound to a second discrete area of said solid support; (c) a second container comprising a first labelled substance capable of selectively binding the test analyte; and (d) a third container comprising a second labelled substance capable of selectively binding the calibrator analyte;
wherein said first and second labelled substances use an identical label. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
-
Specification