Evaluation of the Performance of an Adiponectin ELISA-based Test and Establishing Serum Adiponectin Reference Intervals for Korean Population

ABSTRACT

BACKGROUND: Adiponectin is a plasma protein secreted by adipose tissues and low serum adiponectin concentration has been reported to be associated with insulin resistance and metabolic syndrome (MS). We evaluated the performance of an ELISA-based assay for measuring serum adiponectin levels and established reference intervals of adiponectin for Korean population. METHODS: Laboratory performance, including precision and linearity, of the AdipoMark Human Adiponectin ELISA kit (Mesdia Co., Korea) was assessed. Reference intervals of adiponectin concentration were determined after evaluation of 1200 subjects with no history of MS. Adiponectin was also measured in 100 patients with MS. RESULTS: The mean concentrations of serum samples tested for precision evaluation were 6.66, 12.61, and 23.42 microg/mL the ELISA showed total imprecision of 13.6%, 9.3%, and 10.5% CV for the respective concentrations. The assay demonstrated linear responses in the range of 1.8-29.9 microg/mL serum adiponectin levels. The 95% reference intervals for Korean population were 3.6-19.2 microg/mL for men and 4.5-34.2 microg/mL for women. ROC-area under the curve values of adiponectin for the diagnosis of MS were 0.85 for men and 0.83 for women. Low adiponectin level was independently associated with MS in the multivariate analysis. CONCLUSIONS: The adiponectin quantitation assay evaluated in this study showed acceptable laboratory and clinical performances in an ELISA platform. To meet the ever-increasing demand for a reliable assay for measuring adiponectin levels in the study of various metabolic diseases, this assay could be further improved by the automation of the platform.