Galectin-3 immunoassay

A method for quantitatively determining a level of galectin-3 in a sample from a subject,

• the method comprising the steps of:
• obtaining from the subject at least one sample comprising whole blood, serum, or plasma;
• contacting the at least one sample with a first binding moiety comprising an M3/38 monoclonal antibody immobilized on a solid surface, wherein the M3/38 monoclonal antibody binds to a first epitope located within an N-terminal region of human galectin-3 and captures the human galectin-3 in the at least one sample to form a first complex;
• contacting the first complex with a second binding moiety comprising a 87B5 monoclonal antibody and a detectable label, wherein the 87B5 monoclonal antibody binds a second epitope located within the N-terminal region of human galectin-3 that does not overlap with the first epitope, thereby forming a sandwich complex comprising the detectable label;
• detecting the detectable label of the second complex to generate a signal proportional to the concentration of human galectin-3 in the sample,
• determining the concentration of human galectin-3 in the biological sample by comparing the signal to a calibration curve generated using known concentrations of human galectin-3;
• wherein the method selectively detects human galectin-3 relative to other galectins present in the biological sample;
• and
• determining that the subject has an increased risk of development or progression of heart failure when the level of the human galectin-3 exceeds a threshold of at least 15 ng/ml.