Clinical biochemistry最新文献

{"title":"Clinical relevance of the Maglumi immunoassay for anti-GAD65 in diabetes and neurological disorders: Analytical challenges and diagnostic insights","authors":"Gonzalo Verdú ,&nbsp;Antonio Jesús Blanco-Carrasco ,&nbsp;Raquel Ruiz-García ,&nbsp;Albert Saiz ,&nbsp;Manuel Morales-Ruiz ,&nbsp;Gregori Casals","doi":"10.1016/j.clinbiochem.2025.111024","DOIUrl":"10.1016/j.clinbiochem.2025.111024","url":null,"abstract":"<div><h3>Introduction</h3><div>Anti-GAD65 is an established diagnostic biomarker for autoimmune diabetes and neurological syndromes associated with GAD antibody-spectrum disorders. Automated chemiluminescence-based immunoassays such as Maglumi are increasingly used, but their behavior at high antibody concentrations remains poorly characterized. We report the analytical concordance between Maglumi and radioimmunoassay (RIA), the cut-off titer that differentiates neurological from diabetic patients, and the hook effect of the immunoassay.</div></div><div><h3>Materials and methods</h3><div>Anti-GAD65 levels were analyzed in samples from 90 patients with suspected autoimmune diabetes or neurological syndromes, using Maglumi 2000® and RIA (Medipan®). Analytical concordance was assessed by Passing–Bablok regression, Bland–Altman plots, and Cohen’s kappa. ROC curve analysis identified diagnostic thresholds, and dilution studies were performed in samples with unexpectedly low values to assess a potential hook effect.</div></div><div><h3>Results</h3><div>Maglumi results were approximately five times higher than RIA results (slope = 5.364; R² = 0.908); agreement was higher in endocrine (R² = 0.998) than in neurological patients (R² = 0.891). A cutoff of 6778 IU/mL discriminated neurological patients from diabetic patients (AUC = 0.96). Sixteen samples showed a hook effect, with direct (undiluted) values ≤273 IU/mL, while the corrected titers after dilution exceeded 20,000 IU/mL. A linear regression confirmed an inverse relationship between direct and true titers (r = –0.79, p &lt; 0.05).</div></div><div><h3>Discussion</h3><div>Maglumi anti-GAD65 immunoassay provides reliable discrimination between endocrine and neurological patients but requires method-specific cutoffs to avoid misclassification. Hook effect was frequent in high-titer neurological samples, potentially leading to misdiagnosis, underscoring the need for routine dilution protocols to improve diagnostic reliability.</div></div><div><h3>Conclusions</h3><div>Standardized dilution protocols and appropriate cutoffs are essential to ensure reliable anti-GAD65 testing with Maglumi chemiluminescent immunoassay, particularly in neurological indications.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111024"},"PeriodicalIF":2.1,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145262378","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":"A rebuttal to: A letter to editor entitled: \"A panel (CA19-9, CEA and PIVKA-II) of serum markers for pancreatic cancer diagnosis\".","authors":"Meifang Wang, Deliang Cao","doi":"10.1016/j.clinbiochem.2025.111026","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.111026","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111026"},"PeriodicalIF":2.1,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273959","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":"Myocardial damage in a 4-year old who ingested bisoprolol and hydrochlorothiazide - Incidental CK-BB highlighted other tissue toxicity.","authors":"Tiziana Zangardi, Sara Altinier, Monica Maria Mion, Michele Cennamo, Ada Aita, Silvia Bressan, Daniela Basso","doi":"10.1016/j.clinbiochem.2025.111028","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.111028","url":null,"abstract":"<p><strong>Introduction: </strong>A 4-year-old girl accidentally ingested an unknown quantity of bisoprolol (2.5 mg)-hydrochlorothiazide (6.25 mg) pills. Initialy asymptomatic, laboratory testing revealed elevated concentrations of cardiac and skeletal muscle injury markers. This case provided insight into potential myocardial toxicity and bone remodeling effects of these antihypertensive medications following acute overdose ingestion.</p><p><strong>Materials and methods: </strong>Upon admission, the patient underwent clinical and laboratory evaluations, which included electrocardiogram (ECG), echocardiography, blood gas analysis, and assessment of biochemical markers for cardiac injury (high sensitivity troponin [hs-TnI], N-terminal pro brain natriuretic peptide [NT-proBNP]) and bone turnover (parathyroid hormone [PTH], vitamin D, bone alkaline phosphatase [bALP], beta cross-laps [CTX]). Bisoprolol was measured in plasma and urine. Creatine kinase (CK) isoenzymes were performed on agarose gel electrophoresis. Activated charcoal was administered; fluids and electrolytes were closely monitored. Clinical and laboratory follow-up continued for two months.</p><p><strong>Results: </strong>The child's vital signs were stable, but a reduced heart rate (75 bpm) developed within 24 h. Elevated hs-TnI and NT-proBNP levels indicated myocardial stress, despite normal ECG and echocardiography findings. The CK-BB isoenzyme increased to 8 % of total CK by day 3. An increase of CTX along with decreased PTH and bALP, suggested thiazide-induced osteoclastic activation. Bisoprolol concentrations quickly decreased over 12 h. The patient was discharged in good condition after 36 h. All biomarkers normalized progressively during follow-up.</p><p><strong>Conclusions: </strong>This case highlights subclinical myocardial toxicity and an unexpected bone remodeling after a pediatric overdose of bisoprolol-hydrochlorothiazide. CK-BB elevation, likely due to osteoclast activity, underscores the importance of monitoring skeletal biomarkers in thiazide exposures. Clinical recovery can occur before biochemical normalization, emphasizing the need for extended follow-up even in asymptomatic cases.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111028"},"PeriodicalIF":2.1,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273981","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":"Optimizing the indeterminate zone for the DiaSorin LIAISON H. Pylori stool antigen test","authors":"Natalia Volodko ,&nbsp;Mathew P. Estey ,&nbsp;Dustin Proctor ,&nbsp;Lily Olayinka ,&nbsp;Michelle L. Parker ,&nbsp;Ashley Newbigging ,&nbsp;Victoria Higgins","doi":"10.1016/j.clinbiochem.2025.111027","DOIUrl":"10.1016/j.clinbiochem.2025.111027","url":null,"abstract":"<div><h3>Introduction</h3><div><em>Helicobacter pylori</em> (<em>H. pylori</em>) colonization increases the risk of upper gastrointestinal disorders and can be detected by various tests, including the stool antigen test (HpSAT). DiaSorin recommends an HpSAT equivocal/indeterminate zone of 0.90-&lt;1.10, but high variability observed in our laboratory prompted clinical implementation of a broader zone (0.60-&lt;1.80). This study aimed to define an optimal HpSAT indeterminate zone using molecular as reference and urea breath test (UBT) for confirmation.</div></div><div><h3>Materials and Methods</h3><div>HpSAT and stool molecular results were available from 379 patients, of which 52 had follow-up UBTs. HpSAT was analyzed by the LIAISON HpSAT assay (DiaSorin), UBT by isotope ratio mass spectrometry, and molecular testing by qPCR targeting <em>H. pylori</em> DNA. Logistic regression modeled HpSAT index values against PCR positivity to define an optimal indeterminate zone, supported by clinical performance and flagging rates analyses.</div></div><div><h3>Results</h3><div>Logistic regression determined an HpSAT index of 0.79 (95 % CI: 0.34–1.14) had 90 % probability of a negative PCR result, and 4.99 (4.09–6.63) had 90 % probability of a positive result, rounded to an indeterminate zone of 0.80-&lt;5.00. Lower thresholds assessed all had ≤ 2 % false negatives, while upper thresholds exhibited decreased false positive rates (22 % to 6 %) as thresholds increased (1.10 to 5.00), with minimal improvement beyond 3.00 (9 %). A modified zone of 0.80–&lt;3.00 offered high accuracy with 12.9 % indeterminate results (DiaSorin’s threshold: 2.8 %; laboratory’s current threshold: 13.1 %).</div></div><div><h3>Conclusions</h3><div>Our findings show that DiaSorin’s HpSAT indeterminate zone is too narrow to reliably distinguish true positive and negative results in clinical practice. A modified broader zone (0.80–&lt;3.00), derived via logistic regression using PCR as reference, improves diagnostic accuracy while minimizing indeterminate results.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111027"},"PeriodicalIF":2.1,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257500","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":"A panel (CA19-9, CEA and PIVKA-II) of serum markers for pancreatic cancer diagnosis","authors":"Guo-Ming Zhang","doi":"10.1016/j.clinbiochem.2025.111025","DOIUrl":"10.1016/j.clinbiochem.2025.111025","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111025"},"PeriodicalIF":2.1,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249966","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":"Plasma lipase and hemolysis on Roche Cobas c503 analysers: No evidence of the need to lower the interference threshold","authors":"Denis Monneret","doi":"10.1016/j.clinbiochem.2025.111022","DOIUrl":"10.1016/j.clinbiochem.2025.111022","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111022"},"PeriodicalIF":2.1,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228484","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":"Rethinking research funding through a sustainability Lens.","authors":"Kevin J Tu, Christina Greever-Wilson","doi":"10.1016/j.clinbiochem.2025.110987","DOIUrl":"10.1016/j.clinbiochem.2025.110987","url":null,"abstract":"<p><p>Research funders can play a transformative role in reducing the environmental footprint of science without compromising its quality or productivity. Scientific research is among the most energy- and resource-intensive sectors globally, with its carbon footprint estimated to rival that of the aviation industry-contributing approximately 2 % of global greenhouse gas emissions. Yet the organizations that fund scientific research, particularly in the United States, structurally disincentivize sustainability, often rewarding waste rather than resource efficiency. We highlight how this is beginning to change across Europe, where major funding agencies are leading a growing movement to embed sustainability into research operations-from including environmental impact assessments in grant proposals to supporting green lab certification programs. These policies are on track to accelerate operational efficiency, reduce costs, and align research practices with climate action goals. Finally, we outline specific policy reforms and practical steps that researchers, institutions, and funders everywhere can adopt to build a more sustainable future for science-one where environmental stewardship is a core expectation of research.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110987"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803720","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":"The biological diagnosis of Alzheimer's disease using blood-based biomarkers: A Canadian prospective.","authors":"Pankaj Kumar, Ali Mousavi, Hans Frykman","doi":"10.1016/j.clinbiochem.2025.110980","DOIUrl":"10.1016/j.clinbiochem.2025.110980","url":null,"abstract":"<p><p>Dementia is the most common type of neurodegenerative diseases, with Alzheimer's Disease (AD) constituting about two-thirds of these cases. In Canada, an estimated 674,000 individuals may have AD by 2031, nearly doubling from 2011. The total annual economic burden of dementia in Canada was about $40 billion in 2020, with an approximate average of $67,200 per person with dementia and if current trends continue, its annual burden could grow by 275 % over 30 years. AD is a double proteinopathy with its fundamental neuropathologic features defined by amyloid-beta (Aβ) plaques and neurofibrillary tangles with aggregated tau proteins. This supports the potential mechanism-based proteomic biomarkers to be detected in biofluids. Pathophysiologic and topographical biomarkers have significantly improved the diagnosis of typical and atypical phenotypes of AD, helping clinicians recognize and differentiate AD phenotypes from other types of dementia and neurodegenerative diseases. The CSF Aβ42/Aβ40 ratio measurement is a robust biomarker in detecting cerebral Aβ pathology and AD diagnosis. A number of very sensitive assays for measuring AD blood biomarkers including p-tau217, front-runner candidate for AD diagnosis, have been developed during last years. In this review we discus the biological configuration and normal function of involved proteomic in AD including amyloid β and tau protein, particularly tau phosphorylation and biochemistry of tau isoforms and their detection feasibility in plasma using novel technologies. Then, we critically review Blood-Based biomarkers' analytical and clinical validations, focusing more on plasma p-tau217 and their availability and prospects in Canada.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110980"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768469","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 \"CA19-9, CEA and PIVKA-II as a novel panel of serum markers for diagnosis of pancreatic cancer\" [Clin. Biochem. 137 (2025) 110902].","authors":"Meifang Wang, Hongying Bu, Weijia Luo, Xi Zeng, Guodong Chen, Yingchun He, Deliang Cao","doi":"10.1016/j.clinbiochem.2025.111017","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.111017","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111017"},"PeriodicalIF":2.1,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205710","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":"The biological diagnosis of Alzheimer's disease using blood-based biomarkers: a Canadian prospective.","authors":"Pankaj Kumar, Ali Mousavi, Hans Frykman","doi":"10.1016/j.clinbiochem.2025.111015","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.111015","url":null,"abstract":"<p><p>Dementia is the most common type of neurodegenerative disease, with Alzheimer's Disease (AD) constituting about two-thirds of these cases. In Canada, an estimated 674,000 individuals may have AD by 2031, nearly doubling from 2011. The total annual economic burden of dementia in Canada was about $40 billion in 2020, with an approximate average of $67,200 per person with dementia and if current trends continue, its annual burden could grow by 275 % over 30 years. AD is a double proteinopathy with its fundamental neuropathologic features defined by amyloid-beta (Aβ) plaques and neurofibrillary tangles with aggregated tau proteins. This supports the potential for mechanism-based proteomic biomarkers to be detected in biofluids. Pathophysiologic and topographical biomarkers have significantly improved the diagnosis of typical and atypical phenotypes of AD, helping clinicians recognize and differentiate AD phenotypes from other types of dementia and neurodegenerative diseases. The cerebrospinal fluid Aβ42/Aβ40 ratio measurement is a robust biomarker in detecting cerebral Aβ pathology and AD diagnosis. A number of very sensitive assays for measuring AD blood biomarkers including p-tau217, front-runner candidate for AD diagnosis, have been developed during last years. In this review we discuss the biological configuration and normal function of involved proteomics in AD including Aβ and tau protein, particularly tau phosphorylation and biochemistry of tau isoforms and their detection feasibility in plasma using novel technologies. Then, we critically review blood-based biomarkers' analytical and clinical validations, focusing more on plasma p-tau217 and their availability and prospects in Canada.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"111015"},"PeriodicalIF":2.1,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198589","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}