Devices and methods for minimizing hook effect interference in immunoassays
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsChris Zimmerle, Gary Rheinheimer
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Abstract
Methods of minimizing hook effect interference in an immunoassay are disclosed. Also disclosed are reagents, kits, and immunoassay devices that may be utilized in accordance with the method.
Claims19
An immunoassay device for determining the presence and/or concentration of a target analyte in a sample, wherein the target analyte comprises a peptide or protein, the immunoassay device sized and shaped for insertion in an automated analyzer, wherein the immunoassay device comprises:
- a sample application chamber capable of receiving a sample suspected of containing the target analyte;
- at least one compartment capable of being in fluidic communication with the sample application chamber, the at least one compartment comprising:
- at least one dye capable of binding to the target analyte, wherein a spectrophotometric absorption band of the at least one dye shifts upon binding to the target analyte;
- at least one capture antibody capable of specifically binding to the same target analyte as the at least one dye;
- and
- at least one detection antibody that binds to the same target analyte, wherein binding of the at least one capture antibody and the at least one detection antibody to the same target analyte molecule generates a signal;
- and
- wherein the at least one dye, the at least one capture antibody, and the at least one detection antibody are disposed in the same at least one compartment;
- and
- at least one actuator capable of being manually and/or automatically actuated to allow for fluidic communication between the sample application chamber and the at least one compartment.
A method for detecting the presence and/or concentration of a target analyte in a sample using an immunoassay and minimizing hook interference in the immunoassay, wherein the target analyte comprises a peptide or protein, and wherein the method comprises the steps of:
- (a) inserting a sample suspected of containing the target analyte into an immunoassay device sized and shaped for insertion in an automated analyzer, wherein the immunoassay device comprises:
- a sample application chamber capable of receiving a sample suspected of containing the target analyte;
- at least one compartment capable of being in fluidic communication with the sample application chamber, the at least one compartment comprising:
- at least one dye capable of binding to the target analyte, wherein a spectrophotometric absorption band of the at least one dye shifts upon binding to the target analyte;
- at least one capture antibody capable of specifically binding to the same target analyte as the at least one dye;
- and
- at least one detection antibody that binds to the same target analyte, wherein binding of the at least one capture antibody and the at least one detection antibody to the same target analyte molecule generates a signal;
- and
- wherein the at least one dye, the at least one capture antibody, and the at least one detection antibody are disposed in the same at least one compartment;
- and
- at least one actuator capable of being manually and/or automatically actuated to allow for fluidic communication between the sample application chamber and the at least one compartment;
- (b) inserting the immunoassay device into an automated analyzer;
- (c) activating the actuator of the immunoassay device to allow for:
- (i) the binding of the dye to the target analyte present in the sample;
- and
- (ii) the binding of the capture antibody to the target analyte present in the sample and the binding of the detection antibody to the target analyte to form an immunoassay complex containing the target analyte, the capture antibody, and the detection antibody;
- (d) detecting a value based on the absorption band of the dye;
- (e) detecting a value based on the signal generated by the immunoassay complex;
- (f) comparing the value detected in step (e) to the value detected in step (d) to determine if hook interference is observed;
- and
- (g) determining the presence and/or concentration of the target analyte based on the value detected in step (e) if hook interference is not observed in the comparison of step (f).
Dependencies are inferred from the claim text.