Clinical Chemistry and Laboratory Medicine

Expert opinion within the context of the targeted evaluation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices pursuant to Article 111 and Regulation (EU) 2024/1860Michael Vogeseron September 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 1. doi: 10.1515/cclm-2025-0941. Online ahead of print. ABSTRACT EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der … Read more

Requiem for the Passing-Bablok nonparametric regression in assessing the agreement between two measurement methodsBruno Mario Cesanaon September 28, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0581. Online ahead of print. ABSTRACT OBJECTIVES: Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is … Read more

Mass spectrometry based precision diagnostics: on the cusp of selective testingMichelle P van der Helmon September 26, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0461. Online ahead of print. ABSTRACT New technologies and advances in human biology are paving the way for better patient management and outcomes in laboratory medicine. Precision diagnostics, as an essential component of P5 medicine, implies a shift towards selective testing of defined measurands, enabling a higher … Read more

Staining and serological characteristics of the AC-30 pattern in HEp-2 IIFA: a comparative study with AC-2 patternChuiwen Dengon September 25, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-0817. Online ahead of print. ABSTRACT OBJECTIVES: To investigate the staining and serological characteristics of AC-30 pattern. METHODS: A total of 184 participants were recruited from patients who underwent routine antinuclear antibody testing between 2022 and 2023 at Peking Union Medical College Hospital. Cohort 1 (n=47) showed … Read more

Establishing reference intervals for high-sensitivity cardiac troponin T in neonates and infantsYue-Qi Lion September 24, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-0985. Online ahead of print. ABSTRACT OBJECTIVES: High-sensitivity cardiac troponin T (hs-cTnT) is used in pediatric healthcare to diagnose and assess the prognosis of various cardiac diseases, such as acute myocarditis, congenital heart disease, dilated cardiomyopathy, and heart failure. However, the standardized age-related reference intervals, 99th percentile … Read more

Moving to practice with the application of Milan model 1b-based analytical performance specificationsMauro Panteghinion September 24, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-1014. Online ahead of print. ABSTRACT The definition of analytical performance specifications (APS) by the Milan model 1b is based on indirect approaches investigating the impact of analytical performance of the laboratory test on clinical classification and thereby on the probability of patient outcomes. As direct diagnostic … Read more

Supporting trend detection in the cumulative display of electronic laboratory reports from multiple laboratories while preserving measurement provenanceAndreas Bietenbeckon September 24, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-1160. Online ahead of print. ABSTRACT Electronic health records will increasingly aggregate longitudinal laboratory results from multiple providers, but availability alone does not guarantee safe interpretation. We present guidance, developed by laboratory professionals with the DGKL medical informatics division, for cumulative displays that are clinically meaningful. The … Read more

Does patient-based data monitoring allow us to reconsider the relationship between IQC and EQA?Tony Badrickon September 23, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 24. doi: 10.1515/cclm-2025-1133. Online ahead of print. ABSTRACT Currently, there is no accepted standard practice for determining the frequency of EQA challenge. The challenge frequency has evolved based on history and local requirements. However, EQA frequency should be based on identifying patient risks caused by poorly performing laboratories, methods, … Read more

Comparative analysis of ISO 15189:2022 with earlier versions with reference to ethicsSudip K Dattaon September 23, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 24. doi: 10.1515/cclm-2025-0884. Online ahead of print. ABSTRACT OBJECTIVES: The International Organisation for Standardisation (ISO) 15189 standard provides the requirements for quality and competence in medical laboratories. It aims to ensure that laboratories deliver accurate and reliable results for patient care. The first version of the same was published … Read more

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