Clinical biochemistry最新文献

{"title":"Degrowth in the clinical laboratory: A key step towards integrating planetary health into the healthcare system","authors":"Manal O Elnenaei ,&nbsp;Andrea Thoni ,&nbsp;Andre Mattman","doi":"10.1016/j.clinbiochem.2025.111029","DOIUrl":"10.1016/j.clinbiochem.2025.111029","url":null,"abstract":"<div><div>Healthcare contributes around 5–10% of global carbon emissions, alongside other pollutants, through utilization of over-stretched planetary resources. This creates a paradox in which efforts to protect health also generate risks to population health by contributing to the decline of planetary ecosystems- the foundation for health on which the healthcare system operates. This unsustainable cycle demands an urgent, unified front across all domains of clinical practice. Laboratory medicine, as a key entry point in the patient diagnostic pathway, is well-positioned to lead the required transformative change. While concepts such as sustainability and stewardship have been used interchangeably to rationalize resource use, the time has come to advance toward a model of ‘degrowth’ in the diagnostic laboratory. In healthcare, degrowth aims to minimize environmental harm by deliberately shrinking the consumption of unnecessary resources, particularly those from diagnostic and therapeutic interventions, without compromising patient outcomes. Diagnostic laboratories can support degrowth activities directly by adopting ‘green laboratory’ practices that include consuming less energy, minimizing waste (especially of reagents and non-recyclables) and optimizing test utilization by curbing low-value or unnecessary testing. They can also make an indirect impact by helping shift healthcare culture through shaping clinical guidelines using a degrowth lens, applying an environmental impact assessment whenever a new test is developed and advocating for sustainability declarations in publications that present new diagnostic approaches or technologies. When supported by effective stewardship programs, laboratories can serve as gatekeepers of diagnostic information and play a powerful role in aligning clinical decision-making with environmental responsibility. By embracing principles of degrowth in laboratory medicine, we have a chance, as well as a duty, to influence healthcare practices towards more ethical and environmentally responsible choices.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111029"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307057","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 ,&nbsp;Deliang Cao","doi":"10.1016/j.clinbiochem.2025.111026","DOIUrl":"10.1016/j.clinbiochem.2025.111026","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111026"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","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":"HER2 gene mutations and matrix biomarkers in breast cancer","authors":"Leyla Karimova ,&nbsp;Gulnara Azizova ,&nbsp;Ilaha Shahverdiyeva","doi":"10.1016/j.clinbiochem.2025.111007","DOIUrl":"10.1016/j.clinbiochem.2025.111007","url":null,"abstract":"<div><h3>Objective</h3><div>Breast cancer (BC) remains a leading cause of morbidity and mortality among women globally. This study aims to investigate <em>HER2</em> mutations in HER2-negative BC and evaluate the diagnostic potential of matrix metalloproteinases (MMP-7, MMP-9) and CYR61 as serum biomarkers.</div></div><div><h3>Material and methods</h3><div>The study involved 74 women diagnosed with BC (HER2-positive: n = 33; HER2-negative: n = 33; triple negative: n = 8) and 25 healthy controls. <em>HER2</em> gene mutations were analyzed using the “AmoyDx HER2 Mutation Detection” kit. Serum MMP-7, MMP-9, and CYR61 levels were quantified using Bio-Techne kits (R&amp;D Systems) using the Quantikine ELISA method.</div></div><div><h3>Results</h3><div>The study found no mutations (A775_G776insYVMA, M774_A775insAYVM, G776 &gt; VC, G776R, G776C, P780_Y781insGSP, V777L, L755P) in exons 18 and 20 of the <em>HER2</em> gene in HER2 negative BC patients.</div><div>MMP-9 serum levels were significantly reduced in BC patients compared to the control group (p &lt; 0.001). However, MMP-7 levels showed no significant variation when compared to healthy women (p = 0.464). CYR61 exhibited high diagnostic accuracy (AUC = 0.95), supporting its potential as a reliable biomarker.</div></div><div><h3>Conclusion</h3><div>The reduction in serum MMP-9 levels correlates with ongoing tissue processes, primarily due to increased consumption in the extracellular matrix. CYR61 overexpression is observed across all breast cancer subtypes, independent of HER2 activity, suggesting its significant potential for use in BC diagnosis and treatment.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111007"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144997110","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 “Optimization and validation of the Kairos Amino Acid Kit for plasma amino acid monitoring in inherited metabolic disorder patients” [Clin. Biochem. 138 (2025) 110960]","authors":"Kiara Theron ,&nbsp;Jeannette Gauthier ,&nbsp;Marijn Van Hulle ,&nbsp;Murray Potter","doi":"10.1016/j.clinbiochem.2025.111036","DOIUrl":"10.1016/j.clinbiochem.2025.111036","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111036"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145451140","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":"Elevated level of platelet factor 4 in follicular fluid is associated with polycystic ovary syndrome","authors":"Wenqi Wang ,&nbsp;Guangxi Wang ,&nbsp;Xiaoming Niu ,&nbsp;Zhonglan Li ,&nbsp;Mingfu Zhang ,&nbsp;Zhenchao Xu ,&nbsp;Tou Liu","doi":"10.1016/j.clinbiochem.2025.111009","DOIUrl":"10.1016/j.clinbiochem.2025.111009","url":null,"abstract":"<div><h3>Objective</h3><div>This present study aimed to measure platelet factor 4 (PF4) protein level in follicular fluid of patients with polycystic ovary syndrome (PCOS) and analyzed the correlation between follicular PF4 level with clinical characteristics.</div></div><div><h3>Methods</h3><div>Sixty-seven women (36 PCOS patients vs. 31 non-PCOS women) were enrolled in the study. Follicular fluid PF4 level was analyzed by enzyme-linked immunosorbent assay.</div></div><div><h3>Results</h3><div>The level of PF4 was significantly higher in follicular fluid of patients with PCOS than that of non-PCOS controls (50.5 (95 % CI: 42.8 to 115.86) ng/ml vs. 37.42 (95 % CI: 23.01 to 49.69) ng/ml, <em>p</em> &lt; 0.001). Correlation analysis showed that the level of PF4 was positively related with serum anti-Mullerian hormone (r = 0.3809, <em>p</em> = 0.0015), serum testosterone (r = 0.3629, <em>p</em> = 0.0025), antral follicle count (r = 0.5544, <em>p</em> &lt; 0.0001), and number of oocytes retrieved (r = 0.3799, <em>p</em> = 0.0018) in all patients. The area under the curve of PF4 level in follicular fluid to predict PCOS was 0.723 (95 % CI: 0.600 to 0.847).</div></div><div><h3>Conclusions</h3><div>Our study demonstrated that the PF4 level was higher in the follicular fluid of patients with PCOS and was associated with key features of PCOS, suggesting that PF4 may play a role in the pathogenesis of PCOS.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111009"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144997109","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 “The biological diagnosis of Alzheimer’s disease using blood-based biomarkers: A Canadian prospective” [Clin. Biochem. 139 (2025); pages 1–17 /110980]","authors":"Pankaj Kumar,&nbsp;Ali Mousavi,&nbsp;Hans Frykman","doi":"10.1016/j.clinbiochem.2025.111014","DOIUrl":"10.1016/j.clinbiochem.2025.111014","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111014"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145516769","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":"Minimizing high sensitivity troponin T delta variation at low concentration using BD Barricor blood collection tube","authors":"Albert K.Y. Tsui ,&nbsp;Jialin Qiu ,&nbsp;Isolde Seiden-Long ,&nbsp;George Cembrowski","doi":"10.1016/j.clinbiochem.2025.111003","DOIUrl":"10.1016/j.clinbiochem.2025.111003","url":null,"abstract":"<div><h3>Objective</h3><div>Reproducible low troponin concentrations from high-sensitivity troponin (hs-cTn) assays are paramount to accurate risk determination in the accelerated diagnostic pathway. Total variation consists of pre-analytical, analytical and biological components. While analytical and biological variations cannot be readily modifiable, minimizing pre-analytical variation is desirable and potentially attainable. The BD Barricor collection tube has previously been demonstrated to reduce pre-analytical variation in test results. The goal of the study is to determine whether BD Barricor tubes provide more reproducible hs-cTnT results compared to plasma separator tubes (PST) at concentrations ≤ 20 ng/L.</div></div><div><h3>Methods</h3><div>Paired intra-patient hs-cTnT results collected less than 1 h apart in the emergency department were retrospectively analyzed from nine urban hospitals which primarily use either PST (n = 336 pairs) or Barricor (n = 327 pairs) collection tubes for troponin. Total variation of the replicated measurements was calculated for hs-cTnT ≤ 20 ng/L. The numbers of paired intra-patient samples were grouped based on decisive absolute delta thresholds as indicated by the European Society of Cardiology 0/1 h algorithm; delta &lt; 3 ng/L, 3–4 ng/L, ≥5 ng/L.</div></div><div><h3>Results</h3><div>The total testing variation for hs-cTnT collected in PST is 14.8 % while Barricor is 8.6 % for hs-cTnT ≤ 20 ng/L. The proportion of delta values &lt; 3 ng/L between the intra-patient replicates is 80.4 % (95 % CI: 75.7–84.5 %) in PST compared to 95.4 % (95 % CI: 92.5–97.4 %) in Barricor (p &lt; 0.001). Median time for serial sampling in PST is 41 min (IQR:18–53) and Barricor is 45 min (IQR 23–54).</div></div><div><h3>Conclusion</h3><div>The use of Barricor tubes demonstrated reproducible and less variable hs-cTnT replicates at concentration ≤ 20 ng/L when compared to a hospital that does not use Barricor tubes.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111003"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144916977","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":"Comparison of capillary dried blood spot and capillary microtubes with venous immunoglobulin G levels for routine diagnostics","authors":"S.L. Boland ,&nbsp;M.J.H. Doeleman ,&nbsp;L.G.E. Hofstee ,&nbsp;L. Soels ,&nbsp;T.S.Q. Visser ,&nbsp;S. de Roock ,&nbsp;D. Hamann ,&nbsp;J.M. van Montfrans ,&nbsp;W.M. Tiel Groenestege","doi":"10.1016/j.clinbiochem.2025.110996","DOIUrl":"10.1016/j.clinbiochem.2025.110996","url":null,"abstract":"<div><h3>Background and aims</h3><div>Patients with primary antibody deficiencies receiving immunoglobulin replacement therapy require frequent monitoring of immunoglobulin G (IgG) levels. Capillary IgG measurements from dried blood spots (DBS) or microtubes offer several advantages over samples obtained by venipuncture, including facilitating remote self-sampling. However, the validity of this alternative method is still unknown. We evaluated the comparability of IgG levels measured in venous samples with capillary blood samples collected on DBS cards and in microtubes.</div></div><div><h3>Methods</h3><div>Paired venous and capillary finger-stick DBS and microtube samples were collected from 100 patients. IgG was extracted from DBS with phosphate buffered saline and measured with a Siemens Atellica CH. For method comparison we performed Deming regression analysis. Absolute mean bias and limits of agreement were calculated with Bland-Altman analysis. The method comparison followed the Clinical Laboratory Improvement Amendments’ (CLIA) recommended approach, but stricter limits proposed by the EFLM were applied. Relative mean differences were compared to a 10.9 % total allowable error (TEa).</div></div><div><h3>Results</h3><div>Method comparison of venous versus capillary DBS samples resulted in an R of 0.77. Mean bias was 0.23 g/L with limits of agreement of −4.06 g/L to 4.53 g/L. Method comparison of venous versus capillary microtube samples resulted in an R of 1.00. Mean bias was −0.11 g/L with −0.67 g/L to 0.46 g/L limits of agreement. Relative mean differences were 2.2 % for DBS sampling and −0.6 % for capillary sampling, both fall within 10.9 % TEa and CLIA criteria.</div></div><div><h3>Conclusion</h3><div>IgG measurements from DBS demonstrated insufficient correlation and excessively broad limits of agreement, making it unsuitable for accurately determining IgG levels. This result hampers implementation of DBS in routine diagnostics. Conversely, capillary microtube samples demonstrated a strong correlation and narrow limits of agreement, which makes them a viable alternative to venipuncture.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 110996"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144902503","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":"Circulating free PSA in breast cancer patients: is it a reliable biomarker?","authors":"Vanessa Susini ,&nbsp;Maria Franzini ,&nbsp;Silvia Ursino ,&nbsp;Maria Ghilardi ,&nbsp;Riccardo Morganti ,&nbsp;Cristian Scatena ,&nbsp;Irene Bianco ,&nbsp;Alessandro Mazzoni ,&nbsp;Matteo Ghilli","doi":"10.1016/j.clinbiochem.2025.111006","DOIUrl":"10.1016/j.clinbiochem.2025.111006","url":null,"abstract":"<div><h3>Introduction</h3><div>Prostate-specific antigen (PSA), a serine protease primarily expressed in the prostate, has also been detected in hormonally regulated female tissues, including the breast. Some studies suggest a correlation between increased levels of circulating free PSA (fPSA) and breast cancer, but its role remains debated. This study aimed to evaluate this association while minimizing hormonal confounding factors.</div></div><div><h3>Methods</h3><div>A total of 82 breast cancer patients (aged 35–86 years) and 31 healthy premenopausal women (aged 18–58 years) were enrolled. Patients had a primary breast cancer diagnosis with no other malignancies and had not undergone preoperative chemotherapy or radiotherapy. Participants with hormonal conditions affecting PSA expression were excluded. fPSA levels were measured using an improved VIDAS® fPSA immunoassay with enhanced analytical sensitivity.</div></div><div><h3>Results</h3><div>Despite the increased sensitivity of the modified assay, fPSA was undetectable in all plasma samples. This may be due to the exclusion of participants with hormonal imbalances who might exhibit higher PSA expression.</div></div><div><h3>Conclusions</h3><div>The absence of androgen receptor (AR)-positive triple-negative breast cancer (TNBC) patients in this cohort further supports the role of androgens in PSA regulation. These findings suggest that fPSA may not be a reliable circulating biomarker for breast cancer. However, a key limitation is the lack of fPSA assessment within breast cancer tissue. Future studies should investigate its expression in tumors, particularly in AR-positive TNBC, and evaluate circulating fPSA and testosterone levels as potential biomarkers of tumor androgenic activity.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111006"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144989191","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":"Method choice for investigation of macrotroponin interference with the Siemens Atellica high sensitivity troponin I assay","authors":"Amir Karin,&nbsp;Catherine Cheng","doi":"10.1016/j.clinbiochem.2025.111004","DOIUrl":"10.1016/j.clinbiochem.2025.111004","url":null,"abstract":"<div><h3>Objectives</h3><div>Macrotroponin refers to circulating immunoglobulin-bound cardiac troponin species that may elevate troponin results in patients with or without myocardial injury, causing diagnostic confusion. Clinical laboratories have been recommended to provide a service for troponin interference investigation. We evaluated the applicability of a Protein A/G IgG-depletion procedure as well as polyethylene glycol (PEG) precipitation for detecting macrotroponin interference with the Siemens Atellica troponin I (TnIH) assay.</div></div><div><h3>Methods</h3><div>Troponin I, IgG, and albumin (internal standard) were measured (Atellica) on the neat and treated plasma to calculate recovery. Reference samples with TnIH ranging from &lt; 1x to &gt; 1000x times the 99th percentile were selected to verify expected recovery. To minimize likelihood of macrotroponin in the reference group, samples with elevated results were only included if recent acute changes in TnIH was documented. 40 samples were used for the IgG-depletion method and 20 for PEG precipitation. 25 samples from patients with unexplained elevation in TnIH were assessed by IgG-depletion.</div></div><div><h3>Results</h3><div>38 of 40 reference group recoveries exceeded 70 % (median 91 %, IQR 15 %, max 129 %) in the IgG-depletion group consistent with literature on other assays. Specimens from patients with incongruent clinical picture had IgG-depletion recovery median of 11 % (IQR 14 %, max 37 %). PEG-precipitation showed large variation (median 103 %, IQR 89 %, max 227 %).</div></div><div><h3>Conclusions</h3><div>IgG depletion using Protein A/G can reliably establish IgG-mediated interference with Atellica TnIH. PEG precipitation results are difficult to interpret likely due to matrix effects, especially at values closer to the 99th percentile.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111004"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999884","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}