Work

EP1374 - ECE_2753 - Analytical performance of an automated LC-MS/MS analyzer for measurements of androgens

Year: 2026

Type: conference-abstract

Abstract: Background & Introduction Hyperandrogenism is a common endocrine disorder in women and female adolescents, and an important diagnostic pillar for polycystic ovary syndrome (PCOS), for example. The diagnosis of PCOS is challenging and requires an accurate quantification of androgens, specifically testosterone, androstenedione, and dehydroepiandrosterone sulfate (DHEA-S). Furthermore, clinical guidelines for PCOS emphasize the necessity of measuring 17-hydroxyprogesterone (17-OHP) to rule out Non-Classic Congenital Adrenal Hyperplasia (NCCAH), a condition that clinically mimics PCOS. Frequently used immunoassays often lack specificity, due to cross-reactivity, and limited sensitivity at lower androgen concentrations. Consequently, liquid chromatography-tandem mass spectrometry (LC-MS/MS) is recommended by international guidelines for accurate steroid measurements. Objective The objective of this study was to evaluate the analytical performance of the selected Ionify® Steroids assays on the Cobas® i 601 analyzer, a fully automated LC-MS/MS analyzer. The evaluation focused on the precision of testosterone, androstenedione, DHEA-S and 17-OHP. Results Testosterone demonstrated lot-to-lot repeatability %CVs ranging from 1.7% to 3.1% and lot-to-lot reproducibility ranging from 1.9% to 3.2%. Androstenedione showed a similar performance, with lot-to-lot repeatability %CVs between 1.6% and 3.2% and reproducibility between 1.9% and 3.2%. For DHEA-S, lot-to-lot repeatability and reproducibility %CVs were below 7% for 89% (8 of 9) of the samples tested. For 17-hydroxyprogesterone, lot-to-lot repeatability and reproducibility %CVs were below 5% for all of the samples. Conclusions The Cobas i 601 analyzer was found to produce accurate, precise, and consistent determinations of testosterone, androstenedione, DHEA-S and 17-OHP. These results support the use of this automated LC-MS/MS system for the reliable quantification of these steroid hormones, facilitating the accurate diagnosis of biochemical hyperandrogenism.

Source: European Journal of Endocrinology

DOI: 10.1093/ejendo/lvag096.1585