Clinical biochemistry最新文献

{"title":"Lipoprotein(a) repeat testing patterns and clinical significance of changes between repeat measurements: a real-world reference change value-based retrospective analysis.","authors":"Beyazıt Semih Yeşil, Meltem Boz, Begüm Dokuzağaç, Şeyma Yeşil","doi":"10.1016/j.clinbiochem.2026.111190","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111190","url":null,"abstract":"<p><strong>Introduction: </strong>We evaluated lipoprotein(a) [Lp(a)] repeat testing patterns, inter-measurement intervals, department-specific repeat testing rates, and the clinical significance of changes between repeat measurements using asymmetric reference change values (RCV) and risk-category reclassification.</p><p><strong>Materials and methods: </strong>All Lp(a) results from 1 April 2024 to 1 April 2026 at a tertiary hospital laboratory in Istanbul, Türkiye, were retrospectively extracted. Results were classified as low (<0.3 g/L), intermediate (0.3-0.5 g/L), or high (>0.5 g/L). The asymmetric RCV, calculated using an individual biological variation coefficient of 10.2% (EFLM Biological Variation Database) and analytical variation coefficient of 3.6% (internal quality control), were + 34.9% and - 25.9%. Pearson chi-square tests and Wilson 95% confidence intervals were applied.</p><p><strong>Results: </strong>Among 1623 patients with 1730 results, 96 (5.9%) underwent repeat testing, generating 107 consecutive pairs. Median inter-measurement interval was 156 days (IQR 71-234). Repeat testing rates did not differ by initial category (low 5.7%, intermediate 8.1%, high 5.3%; χ² = 1.693, p = 0.429). RCV exceedance occurred in 23.4% (95% CI 16.4-32.2%), clinical reclassification in 11.2% (95% CI 6.5-18.6%), and both in 5.6% (95% CI 2.6-11.7%). RCV exceedance by baseline category was 20.8%, 33.3%, and 25.0% in low, intermediate, and high pairs, respectively. RCV exceedance did not differ between <90-day and ≥ 90-day intervals (17.6% vs. 26.0%, p = 0.340).</p><p><strong>Conclusions: </strong>Most repeat measurements remained within the RCV, and clinical reclassification was uncommon. Initial Lp(a) category did not predict repeat testing behaviour, suggesting requesting decisions reflect clinical context rather than the biochemical result. These findings support selective, indication-driven repeat testing rather than routine serial monitoring.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111190"},"PeriodicalIF":2.3,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148891043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From selective testing to actionable prevention: The VALOR-ED pathway.","authors":"Deen Dayal, Rajesh Prasad Jayaswal, Kundan Kumar Chaubey, Ashwani Kumar Sanghi, Maajid Mohi Ud Din Malik, Ashish Vyas","doi":"10.1016/j.clinbiochem.2026.111184","DOIUrl":"10.1016/j.clinbiochem.2026.111184","url":null,"abstract":"<p><p>Broul and colleagues provide a timely high-value approach to laboratory testing in erectile dysfunction and suspected hypogonadism. We extend their analysis by proposing VALOR-ED, a five-component pathway that links phenotype verification, analytical fitness, cardiometabolic risk, selective reflex testing, and actionable reporting. The framework addresses assay variability, borderline biochemical results, diagnostic inequity, and the frequent disconnect between laboratory testing and preventive care. Multicentre validation across diverse laboratory platforms and health systems could establish an internationally applicable benchmark for clinically actionable and equitable testing.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111184"},"PeriodicalIF":2.3,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing high-value testing: response to the VALOR-ED pathway.","authors":"Marek Broul, Petr Kelbich, Adéla Jizerová, Dagmar Partlová, Aneta Hujová, Michaela Liegertová","doi":"10.1016/j.clinbiochem.2026.111185","DOIUrl":"10.1016/j.clinbiochem.2026.111185","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111185"},"PeriodicalIF":2.3,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primer part 3 - evaluating, disseminating and sustaining a laboratory quality improvement project.","authors":"Mary Kathryn Bohn, Roy Augustin, Lucas B Chartier, Luke Devine, Samik Doshi, Leanne Ginty, Elliot Lass, Felix Leung, William Mundle, Graeme Nimmo, Alyson Sandy, Kelly Shillington, Amanda Simon, Amanda Steiman, Ahmed Taher, Cindy Tang Friesner, Cristina Zanchetta, Jennifer Taher","doi":"10.1016/j.clinbiochem.2026.111186","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111186","url":null,"abstract":"<p><p>There is a lack of resources on how to prepare, execute, and sustain quality improvement (QI) initiatives in laboratory medicine. The project goal was to bridge this gap with the creation of a novel primer series. In this third and final primer, we discuss fundamental concepts related to project evaluation, dissemination, and sustainability. We also introduce useful tools to successfully assess and monitor QI project success over time, including run charts and statistical process control charts as well as a well established sustainability model. These concepts are illustrated by following through on the final results from our real-world clinical vignette related to serum protein electrophoresis (SPEP) utilization. The impact of interventions discussed in earlier articles of the primer series was evaluated over a one-year period. Data analysis showed there was a >99% reduction in repeat SPEP testing in less than 75 days. The secondary aim to reduce testing in patients <50 years was not met. By piecing together the central aspects of QI methodology and challenges encountered from project initiation to dissemination through a laboratory lens, this series aims to support engagement of clinical laboratory leaders in QI initiatives. This is essential to build a strong culture of QI within the clinical laboratory and beyond.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111186"},"PeriodicalIF":2.3,"publicationDate":"2026-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148860251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of individual false-low total bilirubin results in neonates and young infants using the bilirubin-to-icteric index ratio.","authors":"Chinelo Nwoke, Rachel L Griffiths, Steve Harris, Tejas Kalaria","doi":"10.1016/j.clinbiochem.2026.111183","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111183","url":null,"abstract":"<p><strong>Objective: </strong>Individual analytical errors in neonatal and infant bilirubin testing may pose serious clinical risk, for example, when very small samples are incompletely aspirated without triggering analyser error flags, causing falsely low results which may mask dangerous levels. Because the routinely measured icteric index (ICT) correlates with bilirubin, we evaluated whether a total bilirubin-to-icteric index ratio (TBIL/ICT) could identify discrepantly low TBIL results.</p><p><strong>Methods: </strong>The study comprised two phases. In the threshold-derivation phase, routinely reported TBIL results were reviewed for infants aged ≤90 days with ICT >26 from Abbott Alinity platforms across three laboratories between June 2023 and May 2024. Visual outliers in the TBIL-ICT relationship were used to derive a TBIL/ICT threshold. The derived threshold was implemented, and triggered cases were reviewed over 19 months from June 2024 to December 2025 in the post-implementation assessment phase.</p><p><strong>Results: </strong>In the derivation cohort of 12,057 qualifying samples, TBIL correlated strongly with ICT (Pearson r = 0.918, p < 0.001; Passing-Bablok regression TBIL = 0.708 × ICT + 13.361). Forty-nine samples (0.41%) were classified as visual outliers. A TBIL/ICT threshold <0.54 detected all visual outliers, with 99.9% specificity and 84.5% positive predictive value (PPV) against visual outlier classification. During the post-implementation assessment, 69 (0.19%) of 35,820 eligible samples triggered the TBIL/ICT <0.54 threshold. Of these, 55 (79.7%) were classified as individual false-low TBIL errors, seven (10.1%) as genuine results, and seven were unclassifiable. PPV was 79.7% for all flagged samples, and 88.7% when excluding unclassifiable samples.</p><p><strong>Conclusion: </strong>A TBIL/ICT ratio < 0.54 demonstrated a good PPV in detecting false-low TBIL results in infants on the Abbott Alinity system and provided a feasible, low-burden safeguard. Platform-specific validation is required before the adoption of TBIL/ICT on other systems.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111183"},"PeriodicalIF":2.3,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-steroidal anti-inflammatory drugs and CYP2C9 - Impacts of genetics and phenoconversion on the risk of adverse effects.","authors":"M Cameron, M A Katzman, C Lalonde, N Tetreault","doi":"10.1016/j.clinbiochem.2026.111180","DOIUrl":"10.1016/j.clinbiochem.2026.111180","url":null,"abstract":"<p><p>Chronic pain affects over a quarter of Canadians and remains a leading cause of outpatient visits. It is prevalent in both adults and children, often persisting into adulthood, and imposes a significant economic burden exceeding $40 billion annually. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management as a safer alternative to opioids. However, the safety and efficacy of NSAIDs are influenced by genetic factors, particularly cytochrome P450 (CYP) polymorphisms, which affect drug metabolism. The CYP2C9 enzyme metabolizes several NSAIDs, and genetic variations can lead to altered drug clearance, increasing the risk of adverse effects such as gastrointestinal bleeding. Pharmacogenomic (PGx) testing, including CYP2C9 genotyping, provides insights into individual drug response, aiding personalized pain management. Guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC) recommend NSAID dose adjustments based on CYP2C9 genotype. Additionally, drug-gene interactions, drug-drug interactions, and phenoconversion further complicate the metabolism of NSAIDs. Phenoconversion, wherein drug-induced or disease-related changes alter an individual's metabolic phenotype independent of their genotype, can significantly impact the metabolism of NSAIDs and therapeutic outcomes, highlighting the need for dynamic clinical assessments. Integrating PGx testing into clinical practice can enhance the safety and efficacy of NSAIDs, reducing adverse effects and optimizing pain treatment. Further research is needed to explore additional genetic and environmental factors, including phenoconversion mechanisms, which influence responses to NSAIDs, paving the way for precision medicine in pain management.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111180"},"PeriodicalIF":2.3,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148711656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to \"Detecting Siemens macrotroponin by a point of care high sensitivity troponin I assay: A first look\" [Clin. Biochem. 143 (2026) 111119].","authors":"Amir Karin","doi":"10.1016/j.clinbiochem.2026.111174","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111174","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111174"},"PeriodicalIF":2.3,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148583554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"Rapid and highly sensitive detection of MYD88/CXCR4 mutations in Waldenström macroglobulinemia by MAS-qPCR: A pilot study\" [Clin. Biochem. 144 (2026) 111141].","authors":"Yuki Kunimune, Mitsuaki Nishioka, Haruka Namba, Kimika Todaka, Tomohiro Fujii, Nayu Kiso, Yukiko Nakahara, Kanae Shinkawa, Yumiko Kumano, Masaki Kodama, Tomoya Ebisui, Ryoga Nishimoto, Naoko Okayama, Yutaka Suehiro, Takahiro Yamasaki, Toshiaki Yujiri","doi":"10.1016/j.clinbiochem.2026.111173","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111173","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111173"},"PeriodicalIF":2.3,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148577382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"Elevated level of platelet factor 4 in follicular fluid is associated with polycystic ovary syndrome\" [Clin. Biochem. 140 (2025) 111009].","authors":"Wenqi Wang, Guangxi Wang, Xiaoming Niu, Zhonglan Li, Mingfu Zhang, Zhenchao Xu, Tao Liu","doi":"10.1016/j.clinbiochem.2026.111160","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111160","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111160"},"PeriodicalIF":2.3,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148444742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multiple myeloma revealed by a pulmonary embolism, with more anodal migration of λ IgG in the β₂ region on serum protein electrophoresis.","authors":"Chaymae Benmoussa, Ayoub Baroudi, Oumayma Abdesselami, Kaoutar Ghomari, Dounia El Moujtahide, El Houcine Sebbar, Mohammed Choukri","doi":"10.1016/j.clinbiochem.2026.111128","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2026.111128","url":null,"abstract":"<p><strong>Introduction: </strong>Serum protein electrophoresis (SPE) is widely used to detect monoclonal gammopathies and other hematologic or inflammatory disorders. IgG monoclonal proteins typically migrate in the gamma region, while IgA frequently migrates in the beta region. However, IgG migration in the β₂ region is an exceptionally rare occurrence that can pose significant diagnostic challenges.</p><p><strong>Case presentation: </strong>We present the case of a 76-year-old woman who was initially diagnosed with acute bilateral pulmonary embolism and deep vein thrombosis as the first clinical manifestation of multiple myeloma. Laboratory findings revealed hypercalcemia, mild anemia, and a monoclonal IgG lambda peak in the β₂ region, which was confirmed by immunofixation. Echocardiography revealed left ventricular dilation with preserved right-sided heart structures. Ten days later, the patient developed cauda equina syndrome due to spinal involvement, requiring urgent surgical decompression.</p><p><strong>Discussion: </strong>This case highlights three exceptionally rare and clinically significant features: (1) IgG monoclonal protein migration in the β₂ region, (2) pulmonary embolism as the first manifestation of multiple myeloma, and (3) severe skeletal complications after minimal trauma. Clinicians should consider underlying monoclonal gammopathy in unexplained thromboembolic events and exercise caution when interpreting atypical SPE patterns, which may be crucial for early diagnosis. The unusual combination of these findings underscores the importance of a comprehensive approach to diagnosing plasma cell disorders.</p><p><strong>Conclusion: </strong>Recognition of more anodal IgG migration and awareness of thromboembolic presentation are crucial to ensure early diagnosis and appropriate management of multiple myeloma.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111128"},"PeriodicalIF":2.1,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147811658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}