Clinical Chemistry and Laboratory Medicine

Model 1b analytical performance specifications – report on the Prague 2025 workshopAndrea R Horvathon August 17, 2026 at 10:00 am

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Clin Chem Lab Med. 2026 Aug 18. doi: 10.1515/cclm-2026-1024. Online ahead of print. ABSTRACT The main purpose of establishing APS is to ensure that test performance aligns with their specific clinical goals. Analytical performance specifications serve multiple functions: as acceptance criteria to verify that in vitro diagnostic medical devices (IVD MD) meet regulatory and quality … Read more

Evaluating variability in 24-hour urine free cortisol measurements: impact of sample collection errorsÖmer Özcanon August 16, 2026 at 10:00 am

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Clin Chem Lab Med. 2026 Aug 17. doi: 10.1515/cclm-2026-0410. Online ahead of print. ABSTRACT OBJECTIVES: 24 hour urine free cortisol measurement is widely used for screening Cushing’s syndrome, but its reliability is limited by variability due to inherent biological variation and variation introduced by collection errors. This study aimed to determine the proportion of inaccurately … Read more

Lipoprotein X as a source of analytical and interpretative interference in routine laboratory testingShanshan Liangon August 14, 2026 at 10:00 am

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Clin Chem Lab Med. 2026 Aug 17. doi: 10.1515/cclm-2026-0950. Online ahead of print. ABSTRACT Lipoprotein X (LpX) is an abnormal lipoprotein-like particle occurring mainly in cholestasis, lecithin-cholesterol acyltransferase deficiency, post-transplant cholestatic liver dysfunction, hepatic graft-versus-host disease, and selected intravenous lipid emulsion or parenteral nutrition settings. Enrichment in phospholipids and unesterified cholesterol, paucity of cholesteryl esters … Read more

A liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of vancomycin in human serum and plasmaSandra Fleischeron August 11, 2026 at 10:00 am

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Clin Chem Lab Med. 2026 Aug 12. doi: 10.1515/cclm-2026-0509. Online ahead of print. ABSTRACT OBJECTIVES: Vancomycin is a glycopeptide antibiotic used to treat severe Gram-positive infections; its narrow therapeutic window makes therapeutic drug monitoring (TDM) critical. We report the development of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure (RMP) to quantify vancomycin … Read more

Harmonizing M-protein analysis: an international, multi-center reproducibility study of mass spectrometry and evaluation of concordance to electrophoretic methodsKatie Thorenon August 10, 2026 at 10:00 am

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Clin Chem Lab Med. 2026 Aug 11. doi: 10.1515/cclm-2026-0844. Online ahead of print. ABSTRACT OBJECTIVES: Serum M-protein analysis is central to the assessment of monoclonal gammopathies. Quantitation and isotyping are commonly performed by SPE or CZE and IFE or IT, respectively. While these assays are widely used, they are characterized by limited sensitivity and subjective … Read more

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