An Isotope Dilution-Liquid Chromatography-Tandem Mass Spectrometry-Based Candidate Reference Measurement Procedure for the Quantification of Dehydroepiandrosterone Sulfate in Human Serum and Plasma

The study developed an isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for quantifying dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma, addressing the limitations of current immunoassays. The RMP demonstrated high selectivity, sensitivity, and matrix-independence, with a measurement range of 0.800 to 8,400 ng/mL. The method showed no statistically significant bias, with relative biases ranging from -1.9 to 3.6% across different sample types. Measurement uncertainties were within acceptable limits, expanding to 7.9-11.1% for low ranges and 7.1-8.3% for high ranges at a 95% confidence level. The RMP's high analytical performance and ability to differentiate DHEAS from other androgens make it suitable for routine assay standardization and clinical sample evaluation.