{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T08:29:58Z","timestamp":1786696198871,"version":"build-2736575974"},"reference-count":40,"publisher":"Walter de Gruyter GmbH","issue":"6","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-0179_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Dehydroepiandrosterone sulfate (DHEAS), the sulfate ester of dehydroepiandrosterone, is one of the most common steroid hormones in the human body and the precursor of several other androgens. It is primarily used as a diagnostic or prognostic indicator in adrenal and reproductive disorders. Present immunoassays for DHEAS lack sensitivity and specificity, being vulnerable to cross-reactivity with endogenous interferences. Therefore, an isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS\/MS)-based candidate reference measurement procedure (RMP) was developed to quantify DHEAS in human serum\/plasma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0179_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We ensured traceability to the International System of Units by using quantitative nuclear magnetic resonance to characterize a commercially available DHEAS reference material used for assay calibration. To mitigate matrix effects and prevent interference co-elution, a two-dimensional heart-cut LC method was employed for LC-MS\/MS, in combination with a solid phase extraction sample preparation protocol. Selectivity was determined by spiking the prepared internal standard with the interferences testosterone, epi-testosterone, dehydroepiandrosterone, 5\u03b1-dihydrotestosterone, and estrone, in analyte free matrix. A post-column infusion experiment and comparison of standard line slopes were performed to evaluate matrix effects. Precision and accuracy were assessed via a multi-day validation experiment, and variability components estimated using analysis of variance-based variance-components analysis. Measurement uncertainty (MU) was evaluated in compliance with current guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0179_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This RMP was suitable for analyzing DHEAS within the 0.800 to 8,400\u202fng\/mL (2.17\u201322,800\u202fnmol\/L) range, demonstrating selectivity, sensitivity, and matrix-independence. Trueness and accuracy assessment revealed a relative bias (n=6) between\u00a0\u22121.9 and 0.3\u202f% for surrogate matrix samples (except for 5.9\u202f% at the lowest level),\u00a0\u22122.3 to 3.6\u202f% for Li-heparin plasma samples and sample dilutions, and an overall bias between 0.7 and 1.8\u202f% (n=60), indicating no statistically significant bias. The measurement process resulted in standard measurement uncertainties (MUs) ranging from 4.0 to 5.6\u202f% for the low range and 3.5\u20134.2\u202f% for the high range. At a 95\u202f% confidence level (k=2), these uncertainties expanded to 7.9\u201311.1\u202f% and 7.1\u20138.3\u202f%, respectively. Reference values, determined from six measurements over multiple days (n=6), had standard MUs between 1.6 and 2.1\u202f% for the low range and 0.9\u20131.7\u202f% for the high range, with expanded MUs of 3.2\u20134.3\u202f% and 1.9\u20133.5\u202f%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0179_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This RMP exhibited high analytical performance for DHEAS quantification and met requirements for measurement uncertainty. Additionally, it enabled differentiation between the DHEAS and other androgens. Consequently, this RMP is suitable for routine assay standardization and clinical sample evaluation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-0179","type":"journal-article","created":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T07:57:49Z","timestamp":1764403069000},"page":"1267-1282","source":"Crossref","is-referenced-by-count":1,"title":["An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of dehydroepiandrosterone sulfate in human serum and plasma"],"prefix":"10.1515","volume":"64","author":[{"given":"Sara Cheikh","family":"Ibrahim","sequence":"first","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeraj","family":"Singh","sequence":"additional","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrin","family":"Gradl","sequence":"additional","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friederike","family":"Bauland","sequence":"additional","affiliation":[{"name":"Chrestos Concept GmbH & Co. KG , Essen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"K\u00f6ppl","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Adolescent Medicine , University Hospital Erlangen , Erlangen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7197-3868","authenticated-orcid":false,"given":"Alexander","family":"Gaudl","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics , University of Leipzig Medical Center , Leipzig , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Geistanger","sequence":"additional","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uta","family":"Ceglarek","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics , University of Leipzig Medical Center , Leipzig , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred","family":"Rauh","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Adolescent Medicine , University Hospital Erlangen , Erlangen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Geletneky","sequence":"additional","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Taibon","sequence":"additional","affiliation":[{"name":"111618 Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2025,12,1]]},"reference":[{"key":"2026081408005194750_j_cclm-2025-0179_ref_001","doi-asserted-by":"crossref","unstructured":"Maninger, N, Wolkowitz, OM, Reus, VI, Epel, ES, Mellon, SH. 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