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Fibroblast growth factor‐19: Development, analytical characterization and clinical evaluation of a new ELISA test

Objective. Since fibroblast growth factor 19 (FGF‐19) is a potent metabolic regulator that influences glucose and lipid homeostasis, our aim was to develop an ELISA assay for measuring FGF‐19 in human serum and to investigate its concentrations in healthy volunteers and patients suffering from metabolic syndrome. Material and methods. A sandwich ELISA method was developed for quantitative determination of human FGF‐19 in serum samples. Blood pressure, waist circumference, FGF‐21 serum levels, serum cholesterol, triacylglycerols, HDL‐cholesterol, LDL‐cholesterol, insulin, glucose, adiponectin, uric acid, creatinine, hs‐CRP and calculated BMI and Quicki insulin sensitivity index were measured in 153 healthy volunteers and 66 persons with metabolic syndrome. Results. Neither sex nor age influenced FGF‐19 serum concentration in the healthy volunteers. Probands with metabolic syndrome had 65 % lower FGF‐19 serum values than the healthy ones (medians 158.6 versus 242.4 ng/L; p<0.01). FGF‐19 correlated with glucose (r = −0.35, p<0.01), HDL (r = 0.24, p = 0.045), triacylglycerols (r = −0.19, p = 0.05) and with a number of other risk facors for metabolic syndrome (r = −0.28, p = 0.01). When adjusted to the concentrations of triacylglycerols, BMI and glucose, and finally to all data pertinent to FGF‐19 (according to correlation analysis), our data indicate that FGF‐19 is an independent marker of metabolic syndrome. Conclusions. The present study demonstrates the analytical properties of the ELISA FGF‐19 assay and its usefulness when studying the metabolic syndrome. Serum concentrations of FGF‐19 could be new key predictors of metabolic syndrome and thereby even a new negative risk factor of atherosclerosis.