BIOMARKER, METHODS, AND COMPOSITIONS THEREOF FOR EVALUATION OR MANAGEMENT OF KIDNEY FUNCTION OR DIAGNOSING OR AID IN DIAGNOSING KIDNEY DYSFUNCTION OR KIDNEY DISEASE
The levels of prouroguanylin (proUGN), or fragments thereof, present in blood are normally low in humans and are proposed to be involved in the physiologic regulation of oral and vascular salt levels in the body. When certain kidney related diseases or kidney dysfunctions occur, the level of proUGN or fragments thereof can rise dramatically and significantly. This rise of proUGN in the serum can be used as a marker to diagnose and, in turn, treat kidney disease, or monitor disease progression of kidney dysfunction, or can be used to predict the outcome of a treatment program for kidney disease and/or dysfunction. The level of proUGN or fragments thereof can be measured by a novel immunological assay, and a positive result above a cut-off value is diagnostic for chronic kidney disease (CKD). The calibration of that immunological assay can be done best by using a full-length appropriately folded and secreted recombinant human protein without any N'- or C' -terminal tags made in a human kidney cell line.
