Evaluation of five multisteroid LC-MS/MS methods used for routine clinical analysis: Comparable performance was obtained for nine analytes

Braun V, Ceglarek U, Gaudl A, Gawinecka J, Müller D, Rauh M, Weber M, Seger C (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Clinical Chemistry and Laboratory Medicine Walter de Gruyter

DOI: 10.1515/cclm-2023-0847

Abstract

A mass spectrometry (LC-MS/MS)-based interlaboratory comparison study was performed for nine steroid analytes with five participating laboratories. The sample set contained 40 pooled samples of human serum generated from preanalyzed leftovers. To obtain a well-balanced distribution across reference intervals of each steroid, the leftovers first underwent a targeted mixing step. All participants measured a sample set once using their own multianalyte protocols and calibrators. Four participants used in-house developed measurement platforms, including IVD-CE certified calibrators, which were used by three participants; the 5th lab used the whole LC-MS kit from an IVD manufacturer. All labs reported results for 17-hydroxyprogesterone, androstenedione, cortisol, and testosterone, and four labs reported results for 11-deoxycortisol, corticosterone, cortisone, dehydroepiandrosterone sulfate (DHEAS), and progesterone. Good or acceptable overall comparability was found in Bland-Altmann and Passing-Bablok analyses. Mean bias against the overall mean remained less than ±10 » % except for DHEAS, androstenedione, and progesterone at one site and for cortisol and corticosterone at two sites (max. -18.9 » % for androstenedione). The main analytical problems unraveled by this study included a bias not previously identified in proficiency testing, operator errors, non-supported matrix types and higher inaccuracy and imprecision at lower ends of measuring intervals. This study shows that intermethod comparison is essential for monitoring the validity of an assay and should serve as an example of how external quality assessment could work in addition to organized proficiency testing schemes.

Authors with CRIS profile

Manfred Rauh Department of Paediatrics and Adolescent Medicine

Involved external institutions

Bioscientia MVZ Labor Karlsruhe GmbH DE Germany (DE) Leopold-Franzens-Universität Innsbruck / University of Innsbruck AT Austria (AT) Universität Leipzig DE Germany (DE) Universitätsspital Zürich (USZ) CH Switzerland (CH)

How to cite

APA:

Braun, V., Ceglarek, U., Gaudl, A., Gawinecka, J., Müller, D., Rauh, M.,... Seger, C. (2023). Evaluation of five multisteroid LC-MS/MS methods used for routine clinical analysis: Comparable performance was obtained for nine analytes. Clinical Chemistry and Laboratory Medicine. https://doi.org/10.1515/cclm-2023-0847

MLA:

Braun, Valentin, et al. "Evaluation of five multisteroid LC-MS/MS methods used for routine clinical analysis: Comparable performance was obtained for nine analytes." Clinical Chemistry and Laboratory Medicine (2023).

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