Comparability, compatibility, equivalence and interchangeability: metrological concepts widely misunderstood in laboratory medicineRaúl Rigo-Bonninon January 9, 2026 at 11:00 am

Clin Chem Lab Med. 2026 Jan 12. doi: 10.1515/cclm-2025-1644. Online ahead of print. ABSTRACT BACKGROUND: Method-comparison studies in laboratory medicine are routinely interpreted using regression-based or Bland-Altman analyses. Although useful descriptively, these statistical procedures are frequently misapplied to infer “agreement”, “equivalence”, or “interchangeability”. Such interpretations overlook essential metrological conditions – including the definition of the … Read more

Six-Color Multiplex Digital PCR Assays for Comprehensive Screening and Identification of Multiple Driver Mutations Associated with Pancreatic Carcinogenesis

Clin Chem. 2026 Jan 9:hvaf181. doi: 10.1093/clinchem/hvaf181. Online ahead of print. ABSTRACT BACKGROUND: Digital polymerase chain reaction (dPCR) is widely recognized for its high sensitivity in detecting low-frequency variants; however, conventional 2-color systems have limited multiplex capacity. Expanding this capability is essential for simultaneous detection of multiple driver mutations in cancer-related genes. KRAS and GNAS … Read more

Multi-analytical identification of the synthetic opioids cychlorphine and methiodone (IC-26) in drug seizures: first detection in EuropePaméla Dugueson January 8, 2026 at 11:00 am

Clin Chem Lab Med. 2026 Jan 12. doi: 10.1515/cclm-2025-1428. Online ahead of print. ABSTRACT OBJECTIVES: The rapid emergence of highly potent synthetic opioids represents a growing challenge for forensic and clinical laboratories. METHODS: We report the first identification in Europe of methiodone (IC-26) and the first detection in France of cychlorphine in drug samples collected … Read more

Establishment of allowable total error for semen analysis based on the state of the art in ChinaYan Zhengon January 8, 2026 at 11:00 am

Clin Chem Lab Med. 2026 Jan 9. doi: 10.1515/cclm-2025-1222. Online ahead of print. ABSTRACT OBJECTIVES: To establish evidence-based analytical performance specifications (APS), specifically allowable total error (TEa), for five fundamental semen analysis parameters (sperm concentration, progressive motility, total motility, morphology, and vitality) in China utilizing the state-of-the-art model, and to compare these specifications with existing … Read more

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