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 immunoassay, the system comprising:
- a primary sensor comprising first immobilized antibodies and configured to generate a first signal based on a presence or absence of a target analyte in a sample;
an attenuated sensor comprising second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and configured to generate a second signal based on the presence or absence of the target analyte in the sample; and
a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals.
1 Assignment
0 Petitions
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.
22 Citations
36 Claims
-
1. A system for identifying a hook effect in an immunoassay, the system comprising:
-
a primary sensor comprising first immobilized antibodies and configured to generate a first signal based on a presence or absence of a target analyte in a sample; an attenuated sensor comprising second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and configured to generate a second signal based on the presence or absence of the target analyte in the sample; and a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
-
-
16. An immunosensor system for identifying a hook effect in an immunoassay, the immunosensor system comprising:
-
a primary immunosensor comprising a first immobilized antibody and configured to generate a first signal based on a sandwich between the first immobilized antibody, a target analyte, and a labeled antibody; an attenuated immunosensor comprising a second immobilized antibody 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 determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
-
-
31. An immunosensor system comprising:
-
a plurality of immunosensors, wherein each immunosensor of the plurality of immunosensors comprises a different concentration of an immobilized antibody specific to an analyte of interest, and each immunosensor is configured to generate a signal based on a sandwich between the immobilized antibody, the analyte of interest, and a labeled antibody; and a processor configured to determine a presence of a hook effect in an immunoassay based on relative values of each generated signal. - View Dependent Claims (32)
-
-
33. A method for identifying a hook effect in an immunoassay, the method comprising:
-
providing a sample to a primary sensor comprising first immobilized antibodies; generating a first signal from the primary sensor based on a presence or absence of a target analyte in the sample; providing the sample to an attenuated sensor comprising second immobilized antibodies provided at a reduced concentration relative to a concentration of the first immobilized antibodies; generating a second signal from the attenuated sensor based on the presence or absence of the target analyte in the sample; determining a ratio of the first and the second signals based on relative values of the first and second signals; and determining a presence or absence of a hook effect in the immunoassay based on the determined ratio. - View Dependent Claims (34, 35)
-
-
36. A method of using an attenuated immunosensor for identifying a hook effect in an immunoassay for a target analyte, the method comprising:
-
applying a sample to a primary immunosensor comprising a first immobilized antibody; generating a first signal from the primary immunosensor based on a sandwich between the first immobilized antibody, the target analyte, and a labeled antibody; applying the sample to the attenuated immunosensor comprising a second immobilized antibody provided at a reduced concentration relative to a concentration of the first immobilized antibody; generating a second signal from the attenuated immunosensor based on a sandwich between the second immobilized antibody, the target analyte, and the labeled antibody; computing relative values of the first and second signals; determining a ratio of the first and second signals based on the relative values of the first and second signals; and determining a presence or absence of a hook effect in the immunoassay based on the determined ratio.
-
Specification