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Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword

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Title: Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword
Authors: Fanelli F., Peitzsch M., Bruce S., Cantu M., Temchenko A., Mezzullo M., Lindner J. M., Hawley J. M., Ackermans M. T., Van Den Ouweland J., Koeppl D., Nardi E., Mackenzie F., Binz P. -A., Rauh M., Keevil B. G., Vogeser M., Eisenhofer G., Heijboer A. C., Pagotto U.
Source: Clinical chemistry and laboratory medicine, vol. 62, no. 6, pp. 1080-1091
Publisher Information: Walter de Gruyter GmbH, 2024.
Publication Year: 2024
Subject Terms: Male, Dehydroepiandrosterone Sulfate, androstenedione, dehydroepiandrosterone-sulfate, harmonization, inter-laboratory performance, liquid chromatography-tandem mass spectrometry, testosterone, Liquid Chromatography-Mass Spectrometry, Medizin, Androstenedione, Naturwissenschaften, Middle Aged, Androstenedione/blood, Androstenedione/analysis, Testosterone/blood, Testosterone/analysis, Testosterone/standards, Humans, Tandem Mass Spectrometry/standards, Tandem Mass Spectrometry/methods, Calibration, Female, Chromatography, Liquid/standards, Chromatography, Liquid/methods, Dehydroepiandrosterone Sulfate/blood, Dehydroepiandrosterone Sulfate/analysis, Dehydroepiandrosterone Sulfate/standards, dehydroepiandrosterone sulfate, 3. Good health, Sonstiges, Tandem Mass Spectrometry, Testosterone
Description: Objectives Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for dehydroepiandrosterone sulfate (DHEAS). We assessed the agreement of androstenedione, DHEAS and testosterone LC-MS/MS measurements among nine European centers and explored benefits of calibration system unification. Methods Androgens were measured twice by laboratory-specific procedures in 78 patient samples and in EQA materials. Results were obtained by in-house and external calibration. Intra- and inter-laboratory performances were valued. Results Intra-laboratory CVs ranged between 4.2–13.2 % for androstenedione, 1.6–10.8 % for DHEAS, and 4.3–8.7 % and 2.6–7.1 % for female and male testosterone, respectively. Bias and trueness in EQA materials were within ±20 %. Median inter-laboratory CV with in-house vs. external calibration were 12.0 vs. 9.6 % for androstenedione (pin-house and external calibration were −13.3 to 20.5 % and −4.9 to 18.7 % for androstenedione, −10.9 to 4.8 % and −3.4 to 3.5 % for DHEAS, −2.7 to 6.5 % and −11.3 to 6.6 % for testosterone in females, and −7.0 to 8.5 % and −7.5 to 11.8 % for testosterone in males, respectively. Conclusions Methods showed high intra-laboratory precision but variable bias and trueness. Inter-laboratory agreement was remarkably good. Calibration system unification improved agreement in androstenedione and DHEAS, but not in testosterone measurements. Multiple components, such as commutability of calibrators and EQA materials and internal standard choices, likely contribute to inter-laboratory variability.
Document Type: Article
File Description: application/pdf; image/jpeg
Language: English
ISSN: 1437-4331
1434-6621
DOI: 10.1515/cclm-2023-1138
Access URL: https://pubmed.ncbi.nlm.nih.gov/38205643
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http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_D833027271511
Rights: CC BY
Accession Number: edsair.doi.dedup.....5a10a95e53833a9bb7208f857d7ffde7
Database: OpenAIRE
Description
Abstract:Objectives Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for dehydroepiandrosterone sulfate (DHEAS). We assessed the agreement of androstenedione, DHEAS and testosterone LC-MS/MS measurements among nine European centers and explored benefits of calibration system unification. Methods Androgens were measured twice by laboratory-specific procedures in 78 patient samples and in EQA materials. Results were obtained by in-house and external calibration. Intra- and inter-laboratory performances were valued. Results Intra-laboratory CVs ranged between 4.2–13.2 % for androstenedione, 1.6–10.8 % for DHEAS, and 4.3–8.7 % and 2.6–7.1 % for female and male testosterone, respectively. Bias and trueness in EQA materials were within ±20 %. Median inter-laboratory CV with in-house vs. external calibration were 12.0 vs. 9.6 % for androstenedione (pin-house and external calibration were −13.3 to 20.5 % and −4.9 to 18.7 % for androstenedione, −10.9 to 4.8 % and −3.4 to 3.5 % for DHEAS, −2.7 to 6.5 % and −11.3 to 6.6 % for testosterone in females, and −7.0 to 8.5 % and −7.5 to 11.8 % for testosterone in males, respectively. Conclusions Methods showed high intra-laboratory precision but variable bias and trueness. Inter-laboratory agreement was remarkably good. Calibration system unification improved agreement in androstenedione and DHEAS, but not in testosterone measurements. Multiple components, such as commutability of calibrators and EQA materials and internal standard choices, likely contribute to inter-laboratory variability.
ISSN:14374331
14346621
DOI:10.1515/cclm-2023-1138