Self-corrected assay device
First Claim
1. An assay device for determining the concentration of an analyte in an aqueous fluid sample containing the analyte and other solutes, comprisinga first reaction zone containing analyte-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the analyte to produce a concentration of H2 O2 which is dependent on the concentration of analyte present in the fluid sample, when the analyte concentration is below a concentration which is saturating with respect to the analyte-specific component,a second reaction zone containing (a) a known quantity of a reference compound which is not present in such aqueous fluid sample, and (b) reference compound-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the reference compound to produce a concentration of H2 O2 which is dependent on the concentration of reference compound present in the second reaction zone,distributing means for delivering such fluid sample to each of the reaction zones, such that substantially the same analyte concentration is present in each reaction zone, when the fluid sample is applied to a single region of the distributing means, andcontained in each of said first and said second reaction zones, a peroxidase enzyme and a dye which can be oxidized in the presence of said enzyme and H2 O2 to a detectable product, at a concentration which is dependent on the concentration of H2 O2 in the associated reaction zone,whereby the analyte-dependent signal generated by additional of sample to the first reaction zone can be corrected for (i) variations in signal level produced by the presence of such other solutes in the reaction zones and (ii) for the kinetics of the peroxidase-catalyzed oxidation of said dye from serum inhibition effects calculated from the second reaction zone.
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Abstract
An assay device and method for determining the concentration of an analyte in a fluid sample. The device includes a porous-matrix reservoir which receives the sample to be assayed, and at least two reaction zones into which sample fluid is drawn from the reservoir. In an embodiment containing two reaction zones, a single-point standard curve which corrects for reduced-signal effects related to loss of reagent activity and linear inhibition effects, is used to determine analyte concentration. In an embodiment containing three reaction zones, a two-point standard curve which corrects for reduced-signal effects related loss of reagent activity and non-linear inhibition effects, is used to determine analyte concentration. Also disclosed is an apparatus which uses the device for automated or semi-automated analyte assay.
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Citations
14 Claims
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1. An assay device for determining the concentration of an analyte in an aqueous fluid sample containing the analyte and other solutes, comprising
a first reaction zone containing analyte-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the analyte to produce a concentration of H2 O2 which is dependent on the concentration of analyte present in the fluid sample, when the analyte concentration is below a concentration which is saturating with respect to the analyte-specific component, a second reaction zone containing (a) a known quantity of a reference compound which is not present in such aqueous fluid sample, and (b) reference compound-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the reference compound to produce a concentration of H2 O2 which is dependent on the concentration of reference compound present in the second reaction zone, distributing means for delivering such fluid sample to each of the reaction zones, such that substantially the same analyte concentration is present in each reaction zone, when the fluid sample is applied to a single region of the distributing means, and contained in each of said first and said second reaction zones, a peroxidase enzyme and a dye which can be oxidized in the presence of said enzyme and H2 O2 to a detectable product, at a concentration which is dependent on the concentration of H2 O2 in the associated reaction zone, whereby the analyte-dependent signal generated by additional of sample to the first reaction zone can be corrected for (i) variations in signal level produced by the presence of such other solutes in the reaction zones and (ii) for the kinetics of the peroxidase-catalyzed oxidation of said dye from serum inhibition effects calculated from the second reaction zone.
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9. An apparatus for determining the amount of an analyte in an aqueous fluid sample containing the analyte and other solutes, comprising
an assay device for determining the concentration of an analyte in an aqueous fluid sample, comprising (a) a first reaction zone containing analyte-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the analyte to produce a concentration of H2 O2 which is dependent on the concentration of analyte present in the fluid sample, when the analyte concentration si below a concentration which is saturating with respect to the analyte-specific component, (b) a second reaction zone containing (i) a known quantity of a reference compound which is not present in such aqueous fluid sample, and (ii) reference compound-specific component means effective, when an analyte-containing fluid sample is added to the zone, to utilize the reference compound to produce a concentration of H2 O2 which is dependent on the concentration of reference compound present in the second reaction zone, (c) distributing means for delivering such fluid sample to each of the reaction zones, such that substantially the same analyte concentration is present in each reaction zone, when the fluid sample is applied to a single region of the distributing means, and (d) contained in each of said first and said second reaction zones, a peroxidase enzyme and a dye which can be oxidized in the presence of said enzyme and H2 O2 to a detectable product, at a concentration which is dependent on the concentration of H2 O2 in the associated reaction zone, whereby an analyte-dependent signal generated by addition of sample to the first reaction zone can be corrected (i) for variations in signal level produced by the presence of such solutes in the reaction zones and for (ii) the kinetics of the peroxidase-catalyzed oxidation of said dye from serum inhibition effects calculated form the second reaction zone; -
a signal detector for measuring such signal value in each of the reaction zones; and processor means for determining form the signal values of the reaction zones (a) the relationship between reference compound concentration and measured signal value, and (b) the concentration of analyte in the first reaction zone, using such determined relationship. - View Dependent Claims (10, 11, 12, 13, 14)
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Specification