Apparatus and method for identifying a hook effect and expanding the dynamic range in point of care immunoassays
First Claim
1. A system for identifying a hook effect in an assay, the system comprising:
- a cartridge comprising;
a sample entry port for receiving a sample;
a conduit in fluidic communication with the sample entry port and configured to receive the sample from the sample entry port;
an array of sensors formed on a substrate that is disposed within the conduit, wherein the array of sensors includes a primary sensor and an attenuated sensor;
a first capture reagent comprising an antigen-binding reagent attached on, or close to the primary sensor, wherein the first capture reagent is configured to generate a first signal based on a presence or absence of a target analyte in the sample;
a second capture reagent comprising an attenuated antigen-binding reagent attached on, or close to the attenuated sensor at a reduced concentration relative to a concentration of the antigen-binding reagent, wherein the second capture reagent is configured to generate a second signal based on the presence or absence of the target analyte in the sample; and
connecting pads formed on the substrate and in electrical connection with the array of sensors; and
an analyzer comprising;
a processor capable of being in electrical connection with the connecting pads, wherein the processor is configured to;
receive the first signal and the second signal via the electrical connection with the connecting pads;
compute relative values of the first signal and the second signal;
determine a degree of incongruence between the relative values of the first signal and the second signal with respect to established dose response curves; and
determine a presence of a hook effect in the assay based on the determined degree of incongruence.
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Accused Products
Abstract
The present invention relates to systems and methods for the rapid in situ determination of the existence of a hook effect and expansion of the dynamic range of a point of care immunoassay. For example, a system for identifying a hook effect and expanding the dynamic range of an immunoassay is provided that may include a primary sensor having first immobilized antibodies that may be configured to generate a first signal based on a presence or absence of a target analyte in a sample. The system may further include an attenuated sensor having second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and that may be configured to generate a second signal based on the presence or absence of the target analyte in the sample. The system may further include a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals and optionally determine the target analyte concentration of the sample.
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Citations
25 Claims
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1. A system for identifying a hook effect in an assay, the system comprising:
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a cartridge comprising; a sample entry port for receiving a sample; a conduit in fluidic communication with the sample entry port and configured to receive the sample from the sample entry port; an array of sensors formed on a substrate that is disposed within the conduit, wherein the array of sensors includes a primary sensor and an attenuated sensor; a first capture reagent comprising an antigen-binding reagent attached on, or close to the primary sensor, wherein the first capture reagent is configured to generate a first signal based on a presence or absence of a target analyte in the sample; a second capture reagent comprising an attenuated antigen-binding reagent attached on, or close to the attenuated sensor at a reduced concentration relative to a concentration of the antigen-binding reagent, wherein the second capture reagent is configured to generate a second signal based on the presence or absence of the target analyte in the sample; and connecting pads formed on the substrate and in electrical connection with the array of sensors; and an analyzer comprising; a processor capable of being in electrical connection with the connecting pads, wherein the processor is configured to; receive the first signal and the second signal via the electrical connection with the connecting pads; compute relative values of the first signal and the second signal; determine a degree of incongruence between the relative values of the first signal and the second signal with respect to established dose response curves; and determine a presence of a hook effect in the assay based on the determined degree of incongruence. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 25)
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15. A system for identifying a hook effect in an immunoassay, the system comprising:
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a conduit configured to receive a sample; an array of sensors formed on a substrate that is disposed within the conduit, wherein the array of sensors includes a primary amperometric electrochemical sensor and an attenuated amperometric electrochemical sensor; a first immobilized antibody on the primary amperometric electrochemical sensor configured to generate a first signal based on a sandwich between the first immobilized antibody, a target analyte within the sample, and a labeled antibody; a second immobilized antibody on the attenuated amperometric electrochemical sensor at a reduced concentration relative to a concentration of the first immobilized antibody and configured to generate a second signal based on a sandwich between the second immobilized antibody, the target analyte, and the labeled antibody; and a processor configured to;
receive the first signal and the second signal, determine a degree of incongruence between relative values of the first signal and the second signal with respect to established dose response curves, and determine a presence of a hook effect in the immunoassay based on the determined degree of incongruence. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24)
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Specification