Clinical biochemistry最新文献

{"title":"Pregnancy or PEG? Polyethylene glycol causes false positive pregnancy test","authors":"Timothy Ming Him Yeung , Elaine Yi Ling Wong , Melody Yee Man Wong , Ching Wan Lam","doi":"10.1016/j.clinbiochem.2025.111019","DOIUrl":"10.1016/j.clinbiochem.2025.111019","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111019"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205668","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":"Measurement uncertainty in derived (calculated) biological quantities: Impact on clinical interpretation","authors":"Raúl Rigo-Bonnin , Virgínia Mas-Bosch","doi":"10.1016/j.clinbiochem.2025.111031","DOIUrl":"10.1016/j.clinbiochem.2025.111031","url":null,"abstract":"<div><h3>Background</h3><div>Measurement uncertainty (MU) is essential for interpreting laboratory results. While MU is often reported for directly measured quantities, it is rarely considered for derived (calculated) ones, despite their widespread clinical use. This study assessed the impact of MU on interpretation of derived quantities by comparing directly measured and calculated results.</div><div><em>Design & Methods:</em> Following ISO/TS 20914:2019 and GUM guidelines, MU was estimated for directly measured and derived biological quantities. Ionized magnesium (iMg) was analyzed as a case, comparing direct measurement with regression-based estimates. The approach was extended to estimated glomerular filtration rate (eGFR), low-density lipoprotein cholesterol (cLDL, direct enzymatic vs. Friedewald), free testosterone (direct vs. Vermeulen calculation), and the anion gap (AG, incorporating calculated bicarbonate). Clinical interpretation was evaluated by comparing coverage intervals with biological reference intervals and clinical decision limits.</div></div><div><h3>Results</h3><div>Direct iMg measurement at 0.520 mmol/L yielded a relative expanded uncertainty (<em>U</em>, <em>k</em> = 2) of 4.1 %. Regression-derived values showed <em>U</em> up to 21.4 %. For eGFR, <em>U</em> ranged from 3.8 % to 5.5 %. At 63 mL/min/1.73 m<sup>2</sup>, coverage intervals overlapped the 60 mL/min/1.73 m<sup>2</sup> decision limit, altering chronic kidney disease staging. Direct cLDL measurement (2.54 mmol/L) had <em>U</em> = 4.8 %, while Friedewald calculation (2.60 mmol/L) showed <em>U</em> = 4.8 %; both overlapped therapeutic decision limits. Free testosterone measurement (0.221 nmol/L) had <em>U</em> = 13.9 %, whereas Vermeulen-derived values (0.210 nmol/L) reached 24.1 %. For AG, an abnormal value (28.2 mmol/L) remained pathological, but values of 20.3 or 14.0 mmol/L overlapped the 18 mmol/L limit, producing indeterminate classification.</div></div><div><h3>Conclusions</h3><div>MU significantly influences the interpretation of derived laboratory quantities, particularly near decision limits. Systematic reporting of MU, in line with international recommendations, would enable more reliable interpretation, improve patient safety, and reduce misclassification in clinical decision-making.</div><div>Abbreviations: MU, measurement uncertainty; eGFR, estimated glomerular filtration rate, cLDL, substance concentration of LDL-cholesterol in serum; fTes, substance concentration of free testosterone in serum; AG, anion gap; iMg, substance concentration of ionized magnesium in serum; tMg, substance concentration of (total) magnesium in serum; Alb, mass concentration of albumin in serum; IP, substance concentration of inorganic phosphate in serum; PaCO<sub>2</sub>, partial pressure of carbon dioxide in arterial blood; BRI, biological reference interval; <em>y</em>, derived quantity; <span><math><mrow><msub><mi>u</mi><mi>c</mi></msub><mrow><mo>(</mo><mi>y</mi><mo>)<","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111031"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145354120","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":"Modified LDL variants in atherosclerosis: molecular pathways, diagnostic potential, and therapeutic perspectives","authors":"Siarhei A. Dabravolski ,&nbsp;Alexander L. Golovyuk ,&nbsp;Olga N. Maltseva ,&nbsp;Aleksandra S. Utkina ,&nbsp;Alikhan Z. Asoyan ,&nbsp;Alexander N. Orekhov","doi":"10.1016/j.clinbiochem.2025.111016","DOIUrl":"10.1016/j.clinbiochem.2025.111016","url":null,"abstract":"<div><div>Modified low-density lipoproteins (LDL) play a pivotal role in the pathogenesis of atherosclerosis, contributing to plaque formation and vascular inflammation. This review explores how a diverse array of forms of modified LDL, including carbamylated LDL, nitrated LDL, and desialylated LDL, along with various enzymatic modifications, contribute to disease progression. We discuss how these alterations promote the formation of a heterogeneous, highly atherogenic pool of particles known as electronegative LDL (LDL(−)). Mechanistic insights highlight pathways involving upregulated scavenger receptors, foam cell formation, and chronic inflammatory responses. The diagnostic and prognostic implications of LDL(−), including its association with autoimmune conditions like rheumatoid arthritis and chronic conditions such as type 2 diabetes, underscore its potential as a biomarker for cardiovascular risk. Emerging therapies targeting LDL(−), such as nanoformulations of single-chain fragment variable antibodies, demonstrate promising efficacy in reducing lesion size and inflammation without adverse systemic effects. Despite these advances, a critical barrier to clinical translation is the lack of standardised, high-throughput assays suitable for routine laboratory use. Future research must therefore prioritise the development and validation of robust clinical assays to quantify these atherogenic particles, a crucial step for establishing their role in advanced risk stratification and for guiding novel therapeutic strategies..</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111016"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145118121","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":"Determining the detection of 216 fentanyl analogs and synthetic opioids and predicting epitopes using four commercial immunoassays","authors":"Carl E. Wolf ,&nbsp;Felix I Medrano ,&nbsp;Justin L. Poklis ,&nbsp;Paul J. Jannetto ,&nbsp;Grace R. Williams","doi":"10.1016/j.clinbiochem.2025.111032","DOIUrl":"10.1016/j.clinbiochem.2025.111032","url":null,"abstract":"<div><h3>Background</h3><div>The United States continues to face a persistent opioid epidemic, now in its fourth wave, characterized primarily by fentanyl analogs. Detecting fentanyl analogs and synthetic opioids is a critical concern to clinical and forensic laboratories.</div></div><div><h3>Objectives</h3><div>Evaluate the ability of each assay to detect the opioids at 1, 10, or 100 ng/mL. 216 opioids from the CDC’s TOM Kits® were evaluated using four commercially available fentanyl immunoassays: ARK™ Fentanyl II, Immunalysis Fentanyl Urine HEIA®, Immunalysis Fentanyl Urine SEFRIA® Drug Screening Kit, and the Lin-Zhi International Fentanyl II Enzyme Immunoassay.</div></div><div><h3>Results</h3><div>The difference in reactivity of the immunoassay’s reagents was evaluated in conjunction with the chemical structure of each opioid. All four immunoassays detected 106 of the 216 opioids at the concentrations tested. Twenty-eight opioids were not detected by any assay and 17 of these were the emerging synthetic opioids. At the lowest concentration tested (1 ng/mL), the ARK™ Fentanyl II assay detected 36 compounds, the Immunalysis SEFRIA® assay detected 74, LZI detected 5, and the Immunalysis HEIA® assay detected 18. The undetected opioids included the surgical anesthetic parent compounds remifentanil and alfentanil, and sufentanil’s metabolite, norsufentanil.</div></div><div><h3>Conclusions</h3><div>The detectability of fentanyl analogs and synthetic opioids varies by assay, and it may be possible to predict the detection or lack thereof for a particular assay based on a pattern elucidated by the analysis of the TOMs Opioid compound set. This data may be used to evaluate the potential false negative or false positive results of commercially available fentanyl and norfentanyl homogeneous immunoassays and to predict the likely target epitope of each assay.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111032"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145516753","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":"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}