Clinical chemistry and laboratory medicine最新文献

{"title":"Value is equal to outcome/costs: how to apply to laboratory medicine.","authors":"Rossella Tomaiuolo, Giuseppe Banfi","doi":"10.1515/cclm-2025-0691","DOIUrl":"https://doi.org/10.1515/cclm-2025-0691","url":null,"abstract":"<p><p>The concept of value, defined as health outcomes achieved per monetary unit spent, has profoundly reshaped modern healthcare delivery. While Value-Based Healthcare models have permeated many clinical disciplines, laboratory medicine has been slow to integrate this paradigm shift. In this opinion paper, we argue for a strategic repositioning of clinical laboratories as core enablers of value in healthcare systems. Laboratory diagnostics, long considered ancillary, should be reframed as pivotal tools that support outcome-based, cost-effective decision-making. We explore how laboratory parameters contribute to clinical value through predictive accuracy, diagnostic specificity, and operational appropriateness - factors that directly influence patient outcomes and resource allocation. Examples such as vitamin D testing, albumin as a biomarker of biological age, and NT-proBNP in heart failure demonstrate the potential and pitfalls of volume-driven laboratory utilization. Beyond technical excellence, we emphasize the importance of interpretive collaboration, health literacy, and ethical stewardship of diagnostic resources. Structural challenges, including commoditization, delocalization via point-of-care testing, and the limited use of patient-reported outcomes in laboratory settings, are critically examined. Finally, we highlight emerging policy frameworks across Europe that align reimbursement models with measurable outcomes, advocating for the integration of laboratories in clinical governance and value-based procurement. In this renewed perspective, laboratories are not merely data providers but agents of personalized, sustainable, and patient-centered care.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074608","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":"Beyond cut-offs: optimizing presepsin for neonatal late-onset sepsis.","authors":"Cinzia Auriti, Domenico Umberto De Rose, Lucilla Ravà, Fiammetta Piersigilli, Maria Paola Ronchetti","doi":"10.1515/cclm-2025-1158","DOIUrl":"https://doi.org/10.1515/cclm-2025-1158","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074586","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":"Impact of renal and hepatic function on dihydropyrimidine dehydrogenase phenotype assessed by enzyme activity in peripheral blood mononuclear cells and uracilemia.","authors":"Sara Contu, Manon Launay, Hélène Bouges Le Royer, Laurence Simon, Audrey Mignot, Eva Seutin, Renaud Schiappa, Philippe Follana, Anne Creisson, Ludovic Evesque, Marie-Christine Etienne-Grimaldi","doi":"10.1515/cclm-2025-0949","DOIUrl":"https://doi.org/10.1515/cclm-2025-0949","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the relationship between uracilemia (U) and dihydropyrimidine dehydrogenase (DPD) activity in peripheral blood mononuclear cells (PBMC) and whether they are influenced by renal or hepatic impairment.</p><p><strong>Methods: </strong>This retrospective study included 176 cancer patients with pre-treatment U (UPLC-MSMS assay) and PBMC-DPD (radioenzymatic assay) analyzed the same day (routine phenotyping). Blood renal (creatinine, BUN) and hepatic (ALT, AST, GGT, ALP, albumin, bilirubin) work-up was performed within 15 days before or up to 4 days after DPD phenotyping. Biochemical markers were categorized according to CTCAEv5.0 grade (G). Glomerular filtration rate (eGFR) was estimated (CKD-EPI and EKFC). Non-parametric statistical tests were used.</p><p><strong>Results: </strong>Prevalence of partial deficiency was 3.4 % based on PBMC-DPD (i.e. ≤100 pmol/min/mg) and 6.3 % based on U (i.e. ≥16 μg/L). No complete deficiency was observed. Fifteen patients out of 176 (8.5 %) exhibited discordant DPD status between PBMC activity and U. The correlation between PBMC-DPD and U was significant but weak (r= -0.309, p<0.001). PBMC-DPD (mean 246, median 235, range 62-926 pmol/min/mg prot) was not influenced by renal or hepatic impairment. U (mean 9.6, median 8.5, range 1.7-57.8 μg/L) was significantly higher in patients with elevated BUN (normal vs. >1-UNL, p=0.009), GGT (G0 vs. G1 vs. G2 vs. G3, p<0.001), AST (G0 vs. G≥1, p=0.015), or with hypoalbuminemia (G0 vs. G ≥ 1, p=0.045). Categorized creatinine or eGFR did not influence U.</p><p><strong>Conclusions: </strong>It remains unclear whether renal and/or hepatic impairment acts as a confounding factor affecting the accuracy of uracilemia testing, or whether truly impacts DPD activity, suggesting caution in U interpretation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074610","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":"Comparison of seven different enzymatic methods for serum glycated albumin in pregnant women: a multicenter study.","authors":"Dandan Sun, Zheng Cao, Mingyuan Jiao, Xiuzhi Guo, Ran Gao, Chaochao Ma, Ying Zhu, Lian Hou, Ying Meng, Meng Wang, Songlin Yu, Yicong Yin, Ling Qiu","doi":"10.1515/cclm-2025-0530","DOIUrl":"https://doi.org/10.1515/cclm-2025-0530","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the consistency of seven enzymatic glycated albumin (GA) assays in pregnant women based on a multicenter study.</p><p><strong>Methods: </strong>Samples were collected from pregnant women at three different gestational stages: 4-13 weeks (n=150), 24-28 weeks (n=300, including 150 GDM subjects), and 29-40 weeks (n=300, including 150 GDM subjects), across three hospitals between July 2022 and December 2023 in China. These samples were analyzed using seven enzymatic GA methods (Lucica, Norudia, BSBE, Maccura, Meikang, Reebio, and Zybio assays). Spearman correlation analysis, Passing-Bablok regression, and Bland-Altman plots were used to evaluate the consistency between the Lucica used in our laboratory and the other selected assays. The effects of albumin concentration and gestational stage on the consistency of GA were evaluated through stratified analyses.</p><p><strong>Results: </strong>The correlation coefficients between Lucica and the other six assays for GA% measurement ranged from 0.741 to 0.906 (p<0.0001), with the mean relative biases ranging from -15.5 to +6.7 %. In trimester-stratified analysis, the highest correlation coefficient was observed in the first trimester for all assays except Maccura, and the bias increased with advancing gestational age for all assays except BSBE. In albumin-stratified analysis (30-45 g/L), the correlation increased with increasing albumin concentration for all assays, while the bias decreased except for BSBE and Maccura assays.</p><p><strong>Conclusions: </strong>Poor analytical consistency was observed in enzymatic GA assays for pregnant women, with discrepancies varying across gestational stages and albumin concentrations. Reference intervals for pregnant women should be established based on trimester-stratified and manufacturer-specific criteria.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074617","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":"16th Congress of the Portuguese Society of Clinical Chemistry, Genetics and Laboratory Medicine.","authors":"","doi":"10.1515/cclm-2025-0675","DOIUrl":"https://doi.org/10.1515/cclm-2025-0675","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074669","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":"Pleural effusion with a thyroid signature: diagnostic utility of pleural fluid thyroglobulin.","authors":"Luca Giovanella, Jessica Barizzi, Petra Petranović Ovčariček, Federica D'Aurizio, Luca Mazzucchelli","doi":"10.1515/cclm-2025-0988","DOIUrl":"https://doi.org/10.1515/cclm-2025-0988","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074677","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":"Critical appraisal of presepsin for diagnosing late-onset sepsis in critically ill neonates.","authors":"XiaoMei Wang, SongQian Yang","doi":"10.1515/cclm-2025-1131","DOIUrl":"https://doi.org/10.1515/cclm-2025-1131","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074589","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":"Measuring neurofilament light in human plasma and cerebrospinal fluid: a comparison of five analytical immunoassays.","authors":"Udit Sheth, Rebecca Harrison, Kyle Ferber, Erin G Rosenbaugh, Amanda Bevis, Rohini Khillan, Michael Benatar, Nicole L Bjorklund, Elena Di Daniel, Glenn A Harris, Olga I Kahn, Yongge Liu, Henrik Zetterberg, Laura L Mitic, Danielle Graham, Tania F Gendron","doi":"10.1515/cclm-2025-0610","DOIUrl":"10.1515/cclm-2025-0610","url":null,"abstract":"<p><strong>Objectives: </strong>Neurofilament light (NfL) is an established biofluid marker of neuroaxonal injury for neurological diseases. Several high-throughput and sensitive immunoassays have been developed to quantify NfL in blood and cerebrospinal fluid (CSF), facilitating the use of NfL as a biomarker in research and clinical practice. However, because of the lack of rigorous comparisons of assays, it has been difficult to determine whether data are comparable and whether assay performance differs. Here, we compared the performance of five NfL immunoassays.</p><p><strong>Methods: </strong>To assess the five NfL immunoassays (Fujirebio, ProteinSimple, Quanterix, Roche and Siemens), we used pooled plasma or pooled CSF, as well as unique samples from 20 healthy controls and 20 individuals with El Escorial defined probable or definite amyotrophic lateral sclerosis (ALS), to evaluate precision, parallelism and/or bias. We also examined correlations between plasma and CSF NfL concentrations within and across assays and evaluated their ability to differentiate healthy controls from individuals with ALS.</p><p><strong>Results: </strong>Four of the five assays demonstrated exemplary performance based on our analyses of precision and parallelism. Across the five assays, NfL concentrations were lower in plasma than in CSF, although they displayed a high degree of correlation. We noted bias across assays; plasma NfL concentrations were lowest for the Roche assay and highest for the ProteinSimple assay. In addition, all assays reliably distinguished healthy controls from individuals with ALS using plasma or CSF NfL.</p><p><strong>Conclusions: </strong>Four NfL assays demonstrated similar analytic performance. Alongside performance, other factors such as costs, accessibility, usability, footprint, and intended use, should be considered.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074650","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":"Analysis of total cholesterol results measured in the initial period of the Croatian screening program for familial hypercholesterolemia: a pilot study.","authors":"Gordana Juričić, Antonija Perović, Jasminka Matica, Kornelija Perković-Radojković, Vesna Horvat, Dario Mandić, Tamara Devčić-Ljubić, Zdravka Doljanin, Irena Užović, Katarina Jedrejčić, Sonja Podolar, Nena Peran, Željka Severinac, Ines Kelava, Ivanka Maldini, Marijan Oršulić, Krešimir Kuleš","doi":"10.1515/cclm-2025-0536","DOIUrl":"https://doi.org/10.1515/cclm-2025-0536","url":null,"abstract":"<p><strong>Objectives: </strong>In 2023, Croatia implemented a screening program for familial hypercholesterolemia (FH) targeting children entering the first grade of primary school. The program is based on total cholesterol (TC) concentration measurements. This pilot study aimed to assess and compare TC results obtained using different analytical platforms during the program's initial phase (2023-2024).</p><p><strong>Methods: </strong>Retrospective data from laboratories across Croatia were analyzed. Results covered the following analyzers: Beckman Coulter AU (BC), Abbott Alinity/Architect c (AA), Roche Cobas c (RC) and Siemens Atellica CH (SA). Statistical analyses included Kruskal-Wallis and chi-square tests using the program's cut-off values. Bland-Altman and Passing-Bablok analyses were used to assess differences in a direct comparison study of 40 samples. To reduce variability, TC values were also expressed as multiples of the median (MoM), calculated separately for each platform.</p><p><strong>Results: </strong>The study included 17,694 children. Median TC values (IQR) differed significantly across platforms: BC (4.3 [3.8-4.7] mmol/L), AA (4.1 [3.7-4.5]), RC (4.1 [3.7-4.5]), and SA (4.0 [3.6-4.4]); p<0.001. BC and SA results differed significantly from all other platforms, while no significant difference was found between RC and AA. The distribution of TC results also varied significantly (p<0.001). In the comparison study, all platforms showed statistically significant differences (p<0.001). In contrast, MoM values showed no statistically significant differences between analyzers (p=0.106) or in distribution when applying various MoM-based cut-offs.</p><p><strong>Conclusions: </strong>Although variations in TC measurements across platforms are small, they are statistically significant and affect FH classification. MoM normalization may support harmonization in future screening protocols.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074600","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":"Proadrenomedullin for prediction of early and mid-term mortality in patients hospitalized for community-acquired pneumonia.","authors":"Amaia Artaraz, Ane Uranga, Ana Jódar, Urko Aguirre, José María Quintana, Carmen Mar, Rosario Menéndez, Javier Aspa, Salvador Bello, Pedro Pablo España, Aitor Ballaz","doi":"10.1515/cclm-2025-0481","DOIUrl":"https://doi.org/10.1515/cclm-2025-0481","url":null,"abstract":"<p><strong>Objectives: </strong>Our study sought to determine the usefulness of biomarkers of systemic inflammation (C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM)) on hospital admission, as compared to the CURB65 score, for predicting 30- and 90-day mortality in patients hospitalized for community acquired pneumonia (CAP).</p><p><strong>Methods: </strong>Observational, prospective study of adults admitted for CAP in four Spanish teaching hospitals. Disease severity was determined within the first 24 h of diagnosis, using the CURB65 score. CRP, PCT and proADM levels were assessed from samples obtained in the Emergency Department (ED). We compared the capacity of the different biomarkers and the CURB65 score to predict pneumonia-related 30- and 90-day mortality.</p><p><strong>Results: </strong>A total of 956 patients hospitalized with CAP were included, 462 in the internal and 494 in the external sample. Of the biomarkers, proADM showed the greatest AUC for predicting 30- and 90-day mortality (0.80 and 0.76 respectively). Mortality at 30 and 90 days increased as proADM levels rose. When proADM was used as a continuous variable, CURB65 showed a similar predictive capacity (AUC 0.80) to both crude and age-adjusted proADM (AUC 0.80 and 0.83 respectively) for 30-day mortality. The same was also true for 90-day mortality. However, proADM used as a categorical variable had a greater predictive capacity for 90-day mortality than the CURB65 score (<0.001).</p><p><strong>Conclusions: </strong>Amongst patients admitted for CAP, the use of proADM obtained in the ED may be useful for identifying patients at greatest risk of mortality, with a similar predictive capacity to the CURB65 score.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145074643","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}