| CPC G01N 33/5306 (2013.01) [B01L 3/502 (2013.01); G01N 21/80 (2013.01); G01N 33/6839 (2013.01); B01L 2200/16 (2013.01); B01L 2300/0861 (2013.01)] | 19 Claims |

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1. 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.
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