Clinical chemistry and laboratory medicine最新文献

{"title":"Rethinking atherogenic risk: is apolipoprotein B a better biomarker?","authors":"Giuseppe Lippi","doi":"10.1515/cclm-2026-0624","DOIUrl":"https://doi.org/10.1515/cclm-2026-0624","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with analytical errors in blood chemistry tests.","authors":"Hyunjung Kim, Soo Jung Lee, Hanwool Cho, Jehoon Lee, Soo-Young Kim, Hae Kyung Lee, Jay Ho Han, HyunYoung Chi, Yeongsic Kim","doi":"10.1515/cclm-2026-0153","DOIUrl":"https://doi.org/10.1515/cclm-2026-0153","url":null,"abstract":"<p><strong>Objectives: </strong>Few studies have systematically evaluated the factors contributing to laboratory errors in the analytical phase. This study analyzed five years of retest data to determine the frequency and characteristics of analytical errors across routine blood chemistry parameters, identify analytes most prone to error, and provide insights for improving test result accuracy.</p><p><strong>Methods: </strong>We retrospectively reviewed retest records for 23 blood chemistry parameters performed between January 2018 and June 2022. Of 18,015,323 total tests, 58,637 (0.31 %) underwent repeat analysis following delta or panic check alerts. Acceptance limits for repeated measurements were established based on CLIA proficiency testing (PT) regulations and the precision of each analyte. Differences in error rates among analytes were assessed using chi-square tests.</p><p><strong>Results: </strong>The overall analytical error rate among retested samples was 1.66 %. Carbon dioxide (19.67 %) and ammonia (16.53 %) demonstrated the highest error rates, whereas alanine aminotransferase (0.04 %), albumin (0.09 %), aspartate aminotransferase (0.11 %), sodium (0.18 %), and chloride (0.24 %) showed very low rates. Electrolytes measured using ion-selective electrodes (sodium, potassium, chloride) exhibited lower error rates than those quantified colorimetrically (calcium, phosphate, magnesium). Analytes prone to evaporation or instability, such as carbon dioxide and ammonia, displayed substantial discrepancies upon retesting.</p><p><strong>Conclusions: </strong>Analytical error rates are influenced by assay complexity, physiological analyte concentration, or specimen stability. Routine retesting may offer limited benefit for high-concentration analytes or methodologically simple assays. In contrast, assays for low-concentration or methodologically complex assays should require more vigilant monitoring. Implementing analyte-specific retesting strategies may enhance laboratory efficiency and improve result accuracy monitoring.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Limitations to the development of Milan model 1b analytical performance specifications.","authors":"Graham Ross Dallas Jones","doi":"10.1515/cclm-2026-0377","DOIUrl":"https://doi.org/10.1515/cclm-2026-0377","url":null,"abstract":"<p><p>A widely accepted approach to setting Analytical Performance Specifications (APS) in laboratory medicine is the Milan models. Milan model 1b is an approach where APS are developed based on patient classification, or clinical decision-making, noting that these factors link to the probability of patient outcomes. This paper describes limitations that should be considered for any APS derived using model 1b, based on any available information from model 2 (biological variation), and model 3 (state of the art). It is also proposed that \"state of the art\", when defined as being tests which are routinely available, influences studies based on clinical surveys as this the background used by doctors to develop their clinical experience, as well as the ability for the APS to be put into routine use. Additionally, when \"state of the art\" is defined as the method used in an outcome study, this becomes a reference where such studies cannot support a smaller assay precision, as the assay performance is only one aspect of the variation in the links between laboratory results and clinical findings. Model 1b studies remain a key approach to assigning clinical meaning to assay performance, however outcomes of these studies need to be taken with awareness of relevant limitations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5.","authors":"Christa Cobbaert, Michael Neumaier, Ettore Capoluongo, Francois Mullier, Matthias Orth, Thomas Streichert, Harjit Pal Bhattoa, Patrick Bossuyt, Lucas Biaggini Barbosa, Mario Plebani, Tomáš Zima","doi":"10.1515/cclm-2026-0580","DOIUrl":"https://doi.org/10.1515/cclm-2026-0580","url":null,"abstract":"<p><p>Regulation (EU) 2017/746 on <i>in vitro</i> diagnostic medical devices (IVDR) was introduced to enhance patient safety and ensure the availability of safe and effective diagnostics across the European Union. However, its implementation has led to substantial unintended consequences, including certification bottlenecks, market withdrawals, diagnostic shortages, and delayed innovation, with disproportionate impact on small and medium enterprises and on healthcare institutions developing in-house <i>in vitro</i> diagnostic devices (IH-IVDs). As a result, thousands of diagnostic tests have been lost during the transition to IVDR. Restrictions imposed by Article 5.5 of the IVDR have proven particularly harmful for IH-IVDs addressing rare diseases, niche indications, and key developments such as precision oncology and precision coagulation, among others. In December 2025, the European Commission published a targeted legislative proposal (2025/0404(COD)) to amend the IVDR. This EFLM position statement critically evaluates the proposed reforms, with a specific focus on the revision of Article 5.5. The proposal introduces a more proportional, risk-based regulatory framework, reduces administrative burden, modernizes clinical evidence requirements, and strengthens predictability and regulatory capacity. Key improvements include removal of the equivalence justification requirement, recognition of existing laboratory quality management systems, increased flexibility in the use and transfer of in-house devices when justified by patient safety or public health, and extension of the in-house exemption to certain clinical trial laboratories. While the proposal represents a significant step forward, remaining challenges include the need for clearer definitions and harmonized guidance to avoid divergent interpretation across Member States. Overall, EFLM strongly supports the adoption of the revised Article 5.5 as proposed in 2025/0404(COD). The reform maintains essential safety and performance safeguards while enabling timely access to innovative, high-quality diagnostics. By reducing unnecessary regulatory barriers and better reflecting laboratory practice, the proposed revision is essential to prevent patient harm, support innovation, and uphold the original objectives of the IVDR in European diagnostic medicine.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pseudovirus reference material and RT-digital PCR reference method for the quantification of human rhinovirus RNA with metrological traceability.","authors":"Huijie Li, Yang Liu, Wenyi Cai, Xiaohua Jin, Wenfeng Huang, Shangjuan Wang, Lingxiang Zhu, Yi Yang, Yu Zhang, Shujun Zhou, Tian Hong, Lulu Zhao, Xun Chen, Haofeng Chen, Yong Guo, Huafang Gao, Meihong Du, Lianhua Dong","doi":"10.1515/cclm-2025-1137","DOIUrl":"https://doi.org/10.1515/cclm-2025-1137","url":null,"abstract":"<p><strong>Objectives: </strong>This study developed a pseudoviral human rhinovirus (HRV) reference material using pseudovirus technology and integrating RT-dPCR with HPLC-IDMS to achieve accurate HRV RNA quantification, aiming to standardize HRV detection across labs and platforms.</p><p><strong>Methods: </strong>We developed an RT-digital PCR (RT-dPCR) reference method for HRV, incorporating reverse transcription efficiency (RTE) correction using HPLC-isotope dilution mass spectrometry (HPLC-IDMS), which enables value assignment of the well-characterized pseudoviral reference material (RM) containing the conserved <i>5'UTR</i> gene.</p><p><strong>Results: </strong>The developed RT-dPCR method demonstrated high analytical sensitivity with a limit of detection (LoD) of eight copies/reaction and a limit of quantification (LoQ) of 11 copies/reaction. RTE was accurately determined as 101.25 % using HPLC-IDMS, enabling metrologically traceable RNA quantification. The pseudoviral RM was characterized using the traceable RT-dPCR method; its reference value and expanded uncertainty were determined to be (3.12 ± 0.69) × 10³ copies/μL (k=2). The RM exhibited sufficient homogeneity and stability for 12 months at -80 °C, and its non-infectious nature coupled with its ability to simulate the entire workflow including nucleic acid extraction offers significant advantages.</p><p><strong>Conclusions: </strong>This study provided essential tools for standardizing HRV detection across different laboratories and platforms. This work enables traceable RNA quantification in SI units and simulates the full analytical process, thereby enhancing the accuracy and comparability of results. Furthermore, this approach serves as a transferable model for developing reference materials and traceable quantification methods for other respiratory pathogens, contributing to advancements in molecular diagnostics and public health.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From research to reality: real-world effectiveness of point-of-care testing in the emergency department.","authors":"Salomón Martin-Pérez, Sandra Fuentes-Cantero, Carmen Navarro-Bustos, José M Garrido, Patricia Fernández-Riejos, Fernando Oltra Hostalet, Isabel Morales Barroso, Herminia Romero, Marta Jiménez-Barragan, Catalina Sánchez-Mora, Antonio Leon-Justel","doi":"10.1515/cclm-2026-0289","DOIUrl":"https://doi.org/10.1515/cclm-2026-0289","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the real-world impact of Point-of-Care Testing on care timeliness and patient flow in the emergency department.</p><p><strong>Methods: </strong>A before-and-after, matched-cohort study was conducted involving 25,291 patients with Emergency Severity Index levels 3-4. A POCT group (n=8,746) was compared against a Central Laboratory Group (n=16,545) to measure length of stay (LOS), time to clinical decision (TCD), and laboratory turnaround time (LTAT).</p><p><strong>Results: </strong>POCT achieved a statistically significant 69.3 % reduction in LTAT. TCD improved by 39.5 % (83.4 min; 127.8 vs. 211.2 min) and overall, LOS decreased by 29.2 % (85.4 min; 207.4 vs. 292.8 min). Subgroup analysis showed the greatest efficiency gains in lab-dependent conditions like fever (34.8 % LOS reduction) and gastroenteritis (37.3 %). The actual device usage rate was 34.58 % in daily clinical practice.</p><p><strong>Conclusions: </strong>Real-world implementation of POCT significantly optimizes ED throughput for high-volume, low-severity patients. These findings validate that the clinical benefits observed in previous controlled trials are reproducible and sustainable in complex, high-pressure clinical settings.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Capillary dried blood microsampling is not suited for dihydropyrimidine dehydrogenase (DPD) phenotyping.","authors":"Kevin Vandenbroucke, Hedwig Stepman, Christophe Stove","doi":"10.1515/cclm-2026-0146","DOIUrl":"https://doi.org/10.1515/cclm-2026-0146","url":null,"abstract":"<p><strong>Objectives: </strong>Dihydropyrimidine dehydrogenase (DPD) phenotyping through uracil and dihydrouracil determination is a well-established approach to identify (partial) DPD deficiencies prior to fluoropyrimidine chemotherapy. However, preanalytical stability has challenged this test for years. This study therefore investigated whether dried blood spots (DBS) can improve preanalytical stability.</p><p><strong>Methods: </strong>Uracil, dihydrouracil, and uridine were determined in 6 mm DBS sub-punch extracts by liquid chromatography-tandem mass spectrometry. Paired venous and capillary DBS were collected from 15 healthy volunteers across three days to evaluate venous-capillary DBS differences. The impact of blood spotting, drying and preanalytical stability for up to two weeks was assessed using venous DBS of the same volunteers.</p><p><strong>Results: </strong>Uracil was elevated in all capillary DBS, with a median of 219 % relative to venous DBS. In addition, the variation between capillary DBS replicates was 29 %, opposed to only 7 % in venous DBS. For dihydrouracil, a small bias of -7 % was observed, while uridine showed no difference, with similar inter-spot variation in venous and capillary DBS. Generation and drying of DBS had statistically significant yet minor effects on all analytes. Venous DBS enhanced preanalytical stability, yielding median uracil levels of 105 % and 107 % after 1 and 2 weeks at room temperature, and no differences for dihydrouracil or uridine relative to overnight dried DBS.</p><p><strong>Conclusions: </strong>Capillary DBS are unsuitable for uracil determination in DPD phenotyping owing to poor agreement with venous DBS and substantial variability. Venous DBS, however, demonstrate superior preanalytical stability over liquid samples and may provide a practical solution for managing preanalytical variables.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Essential laboratory tests in emergencies; on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Committee on Preparation of Laboratories for Emergencies (C-PLE).","authors":"Giuseppe Lippi, Maia Alkhazashvili, Moreno Y Banuls Laetitia, Janne Cadamuro, Elisa Danese, Luis García de Guadiana Romualdo, Hervé Delacour, Emmanuel J Favaloro, Julien Favresse, Brandon M Henry, Snežana Jovičić, Marge Kütt, Tomris Ozben, Katell Peoc'h, Avi Peretz, Antonija Perović, Virginia Quaresima, Jecko Thachil, Dogan Yucel, Mario Plebani","doi":"10.1515/cclm-2026-0577","DOIUrl":"10.1515/cclm-2026-0577","url":null,"abstract":"<p><p>This article aims to define a minimum panel of essential laboratory tests to be used in emergency and disaster settings through expert consensus. A structured survey was distributed to the 24 members of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Committee on Preparation of Laboratories for Emergencies (C-PLE). Participants were asked to rate a predefined list of diagnostic tests using a four-level priority scale (essential, critical, supportive, not recommended), with scores ranging from 1 to 4. Responses were collected over a two-week period, and mean scores with standard deviations were calculated to classify each test into priority categories. Additional test suggestions were also solicited and evaluated. A total of 20/24 members (83.3 %) completed the survey. Tests classified as essential (mean score 1.00-1.49) included complete blood count, electrolytes (sodium, potassium, chloride), blood glucose, lactate, blood gases (including ionized calcium), urinalysis, and ABO/RhD blood typing. Critical tests (mean score 1.50-2.49) comprised urea and/or creatinine, coagulation parameters such as prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (APTT), aminotransferases (especially alanine aminotransferase; ALT), and cardiac troponins. Supportive tests (mean score 2.50-3.49) included C-reactive protein, D-dimer, rapid diagnostic tests for infectious diseases, and procalcitonin. Additional tests, such as urine pregnancy testing, bilirubin, and pancreatic enzymes, were proposed for potential inclusion based on clinical relevance. These findings establish a prioritized, consensus-based diagnostic framework tailored to resource-limited emergency contexts, emphasizing rapid, high-impact testing to support clinical decision-making and patient outcomes.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical agreement and platform-specific decision thresholds for plasma p-tau217 measured on Lumipulse G600II and Cobas e801 in a paired CSF-plasma cohort.","authors":"María Martínez-Bujidos, Alex Menéndez, Jose Arnau Pulido-Gracia, Dolores Vilas, Daniela Samaniego, Lourdes Ispierto, Cristian Morales-Indiano, Pau Pastor","doi":"10.1515/cclm-2026-0395","DOIUrl":"10.1515/cclm-2026-0395","url":null,"abstract":"<p><strong>Objectives: </strong>Plasma phosphorylated tau at threonine 217 (p-tau217) has emerged as a highly accurate blood-based biomarker of Alzheimer's disease (AD) pathology. As disease-modifying anti-amyloid therapies enter clinical practice, scalable biomarkers with robust and clinically interpretable decision thresholds are required. However, evidence on inter-platform comparability and threshold transferability across automated assays remains limited.</p><p><strong>Methods: </strong>We conducted a head-to-head comparison of two automated platforms - Lumipulse^® G600II and Cobas^® e801 - for plasma p-tau217 measurement in 157 consecutive patients undergoing lumbar puncture. Amyloid status was defined by the CSF Aβ42/Aβ40 ratio. Agreement was assessed using intraclass correlation coefficients and Bland-Altman analysis. Diagnostic performance was evaluated using receiver operating characteristic curves. Optimal thresholds were derived using the Youden index. Predefined rule-out (≥95 % sensitivity) and rule-in (≥95 % specificity) thresholds were explored, alongside alternative ≥90 % thresholds.</p><p><strong>Results: </strong>Agreement between platforms was excellent (Spearman ρ=0.922; ICC(3,1)=0.922), although Bland-Altman analysis revealed a small systematic difference in absolute concentrations. Both assays showed comparable diagnostic accuracy for amyloid positivity (AUC=0.923 for both platforms; DeLong p>0.99), but required platform-specific thresholds. Rule-out and rule-in thresholds achieved ≥95 % sensitivity and specificity, with strong likelihood ratios and excellent categorical agreement (weighted κ=0.870). Approximately 30 % of individuals were classified in the grey zone. Using ≥90 % thresholds reduced the grey zone to 9-13 % while maintaining excellent agreement.</p><p><strong>Conclusions: </strong>Plasma p-tau217 demonstrates high analytical concordance and comparable diagnostic performance across automated platforms despite systematic concentration differences. Platform-specific dual-threshold strategies may support structured and clinically interpretable implementation, pending prospective multicenter validation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automated detection of mulberry bodies in urinary sediment for non-invasive Fabry disease screening.","authors":"Hiroshi Yamanaka, Tetsumin So, Naoko Sakamoto, Saki Aoto, Xiao-Kang Li, Yi Wang, Qian Shen, Ohsuke Migita, Motomichi Kosuga, Kohji Okamura","doi":"10.1515/cclm-2026-0345","DOIUrl":"https://doi.org/10.1515/cclm-2026-0345","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147811755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}