Clinical biochemistry最新文献

{"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":"https://doi.org/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":"2025-07-31","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":"Waste management and environmental health impact: sustainable laboratory medicine as mitigating response.","authors":"Nnenna Linda Nwobi, Gloria Oiyahumen Anetor, Joseph Chigbogu Nwobi, Godwin Osaretin Igharo, Anuoluwapo Victor Adeyemi, Tony Badrick, John Ibhagbemien Anetor","doi":"10.1016/j.clinbiochem.2025.110985","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110985","url":null,"abstract":"<p><p>Unregulated and unsustainable human, industrial, and scientific activities generate various forms of waste which contribute immensely to the current rising global, multifaceted environmental health challenges. Laboratory medicine practices continue to be a key contributor to this menace with continuous generation of waste ranging from hazardous chemicals and toxic heavy metals to pathogenic biological waste, all of which pose significant risks to environmental and public health. While the wider scientific community has made significant attempts to adopt sustainable practices aligned with the United Nations Sustainable Development Goals, the laboratory medicine sector has lagged behind in implementing effective waste management strategies, particularly in developing countries, highlighting the need for targeted sustainable laboratory medicine practices. This review analysed relevant existing literature on the impact of laboratory waste on environmental health and explored sustainable laboratory medicine as a potential mitigating approach. The findings revealed that inefficient waste management significantly contributes to environmental degradation. Implementing sustainable laboratory (also known as green laboratory) practices such as use of eco-friendly materials, energy-efficient protocols, resource conservation, innovative waste minimisation, and treatment technologies appears to be a crucial framework that will mitigate the threat posed by laboratory-derived waste on environmental health. The review emphasised the need for a paradigm shift towards sustainable laboratory practices, advocating for comprehensive training, institutional commitment, and regulatory support to mitigate the environmental health impacts of laboratory-generated waste. This will ensure that laboratory medicine continues to advance without compromising public health or the planet.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110985"},"PeriodicalIF":2.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768487","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":"Monitoring free plasma hemoglobin in ECMO patients: a two-center comparative study of second-derivative spectrophotometry and hemolysis indexes.","authors":"Théo Sharaiha, Nolan Pellecuier, Sandrine Dabernat, Fouzi Mestari, Brigitte Colombiès, Emmanuel Richard, Rana Alkouri, Dominique Bonnefont-Rousselot, Benoit Rucheton, Marie-Lise Bats","doi":"10.1016/j.clinbiochem.2025.110983","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110983","url":null,"abstract":"<p><strong>Background and aims: </strong>Extracorporeal membrane oxygenation (ECMO) can induce massive intravascular hemolysis, commonly quantified by plasma free hemoglobin (fHb) measurement. While manual spectrophotometry using second derivative spectrophotometry (sDS) is the reference method, a recent assessment tool based on the hemolysis index (HI) was developed for fHb determination on different automated systems. This study compares the performance of two HI methods-on Roche Cobas c502 and Abbott Architect c16000-versus sDS in 83 ECMO patients.</p><p><strong>Materials and methods: </strong>Method validation was performed on both automated HI systems, including determination of linearity, precision, and analytical interference from lipemia and icterus. Plasma fHb measurements in 83 ECMO patients from two hospital centers were compared between the two HI-derived methods and two manual sDS methods (at 415 nm and 578 nm).</p><p><strong>Results: </strong>Both HI-automated methods showed excellent linearity (0.04-20 g/L) and reproducibility (CVs between 2.3 % and 6.3 %). However, they exhibited sensitivity to interference by high lipemic index, leading to underestimation of fHb for Abbott Architect and overestimation for Roche Cobas. In non-lipemic ECMO samples with fHb levels >0.10 g/L, a very good correlation was found between HI and sDS, especially at 578 nm. However, discrepancies were observed in lipemic samples, leading to clinically relevant biases for fHb values >0.50 g/L.</p><p><strong>Conclusion: </strong>The Roche Cobas and Abbott Architect HI methods are reliable tools for monitoring fHb in ECMO patients, with good reproducibility and linearity. However, in the presence of significant lipemia, confirmation by sDS is recommended to ensure accurate assessment of hemolysis. This approach facilitates an efficient and automated monitoring of fHb, essential for daily managing ECMO-related complications and improving patient outcomes.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110983"},"PeriodicalIF":2.1,"publicationDate":"2025-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741351","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":"Low vacuum (3 mL) rapid serum tubes offer better protection from hemolysis than plasma separator tubes collected in the emergency department","authors":"Emily Shang ,&nbsp;Taylor Takasugi ,&nbsp;Pedro Prellwitz ,&nbsp;Cristina Figueroa Villalba ,&nbsp;Rohit B. Sangal ,&nbsp;Arjun K. Venkatesh ,&nbsp;Lisa Maciejak ,&nbsp;Erica Oberle ,&nbsp;Joe M. El-Khoury","doi":"10.1016/j.clinbiochem.2025.110984","DOIUrl":"10.1016/j.clinbiochem.2025.110984","url":null,"abstract":"<div><h3>Introduction</h3><div>Hemolysis is a major source of interference with laboratory testing, especially for the emergency department (ED), leading to longer turnaround times for test results, repeated blood draws, delay in care delivery, and increased hospital costs. Rapid serum tubes (RST) can reduce transport-induced hemolysis, especially for samples sent via the pneumatic tube system, as compared with plasma separator tubes (PST). Previously, studies testing the efficacy of RST used larger volume 5 mL tubes to compare to 4.5 mL PST tubes. In this study, a lower vacuum RST (3 mL) is compared to PST (3.5 mL) for hemolysis reduction.</div></div><div><h3>Methods</h3><div>Paired PST and RST blood samples from 47 ED patients were included in this study. RST and PST samples were sent via the pneumatic tube system and inspected for degree of clotting prior to centrifugation. All samples were tested within the hour for high-sensitivity troponin (hs-cTnT), hemolysis, lactate dehydrogenase, and potassium.</div></div><div><h3>Results</h3><div>Degree of hemolysis was significantly lower in fully clotted RSTs compared to PSTs (p = 0.0005). In RSTs that only partially clotted and PSTs, differences in hemolysis rates were non-significant (p = 0.273). The hs-cTnT levels in RST and PST are concordant with a slope of 0.96, an intercept of 1.01 ng/L and an R-squared value of 0.9318.</div></div><div><h3>Conclusion</h3><div>Fully clotted low-vacuum RSTs provide improved protection from transport-induced hemolysis compared to low-vacuum PSTs or partially clotted RSTs. Low-vacuum RSTs also provided more hemolysis protection than larger volume RSTs previously studied. Clot formation prior to transport is key to the protective mechanism of RST. Blood device manufacturers are encouraged to develop low vacuum RST for use by the ED and other areas with high hemolysis rates.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110984"},"PeriodicalIF":2.1,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728290","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":"Metabolic score for insulin resistance (METS-IR) as a predictor of gestational diabetes: Findings from a prospective Iranian cohort study","authors":"Safoura Rouholamin ,&nbsp;Maryam Razavi ,&nbsp;Reihaneh Pirjani ,&nbsp;Mahroo Rezaeinejad","doi":"10.1016/j.clinbiochem.2025.110982","DOIUrl":"10.1016/j.clinbiochem.2025.110982","url":null,"abstract":"<div><h3>Background</h3><div>Gestational diabetes mellitus (GDM) represents a significant metabolic challenge in pregnancy, with relevance for Middle Eastern populations showing high prevalence rates. The metabolic score for insulin resistance (METS-IR) has emerged as a potential early predictor, though its performance in Iranian populations remains underexplored.</div></div><div><h3>Methods</h3><div>In this prospective cohort study conducted at Arash Women’s Hospital, Tehran (2020–2023), we enrolled 1,845 pregnant women during their first trimester (&lt;12 weeks gestation). Participants underwent comprehensive metabolic evaluation including calculation of METS-IR. GDM diagnosis was established at 24–28 weeks using 75-g oral glucose tolerance test per American Diabetes Association criteria. We employed modified Poisson regression with robust variance estimation to assess associations, adjusting for key confounders identified through directed acyclic graphs.</div></div><div><h3>Results</h3><div>The study population demonstrated a GDM incidence of 19.78 % (365/1845). METS-IR showed strong predictive capacity with area under the ROC curve (AUC) of 0.82 (95 % CI: 0.79, 0.83). At the optimal cutoff of 2.36 (95 % CI: 2.30–2.41), sensitivity reached 72 % (95 % CI: 67, 76 %) and specificity 76 % (95 % CI: 74, 78 %). Adjusted risk ratios revealed a striking dose–response relationship across quartiles: Q2 = 4.21 (2.16, 8.23), Q3 = 8.85 (4.66, 16.78), and Q4 = 18.94 (10.16, 35.29) compared to the reference quartile.</div></div><div><h3>Conclusion</h3><div>This study establishes METS-IR as a robust early predictor of GDM in Iranian women, demonstrating superior performance to conventional metabolic markers. The simple calculation and strong predictive validity suggest its potential for first-trimester risk stratification in clinical practice, particularly valuable in high-prevalence populations.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110982"},"PeriodicalIF":2.1,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728291","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":"LRG and NGAL are potential diagnosis and disease activity biomarkers for inflammatory bowel disease","authors":"Dongdan Zhang ,&nbsp;Yue Meng ,&nbsp;Dan Li ,&nbsp;Shaomei Zhu","doi":"10.1016/j.clinbiochem.2025.110981","DOIUrl":"10.1016/j.clinbiochem.2025.110981","url":null,"abstract":"<div><h3>Background</h3><div>Neutrophil gelatinase-associated lipocalin (NGAL) and serum leucine-rich α-2 glycoprotein (LRG) are reported as potential biomarkers in inflammatory bowel disease (IBD), but the difference in diagnostic efficacy has not been reported. We aimed to investigate the clinical value of NGAL and LRG in IBD diagnosis and disease assessment.</div></div><div><h3>Methods</h3><div>One hundred IBD patients, including 75 Crohn’s disease (CD) and 25 ulcerative colitis, and 100 healthy controls were enrolled. The serum NGAL and LRG concentrations were quantified by enzyme linked immunosorbent assay. Receiver operating characteristic (ROC) curve analysis was used to evaluate their diagnostic performance.</div></div><div><h3>Results</h3><div>The serum concentrations of NGAL and LRG were significantly higher in IBD patients than in healthy controls (<em>P</em> &lt; 0.001). Serum NGAL is significantly correlated with LRG (r = 0.574, <em>P</em> &lt; 0.001). Serum LRG showed a better capacity to identify IBD with an area under the ROC curve (AUC) of 0.90 (sensitivity 89 %, specificity 78 %), compared to NGAL with an AUC of 0.84 (sensitivity 85 %, specificity 71 %). Additionally, serum NGAL and LRG were highly correlated with disease activity in CD patients (r = 0.865 and 0.878, <em>P</em> &lt; 0.001), and gradually increased with disease activity severity (<em>P</em> &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>Serum NGAL and LRG are potential diagnostic and disease activity biomarkers for IBD, which have good clinical application value.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110981"},"PeriodicalIF":2.5,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706544","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":"Navigating an unexpected creatinine result during a pre-intravenous contrast renal function workup","authors":"Madhusudhanan Narasimhan,&nbsp;Kibibi Smith,&nbsp;Alagarraju Muthukumar","doi":"10.1016/j.clinbiochem.2025.110979","DOIUrl":"10.1016/j.clinbiochem.2025.110979","url":null,"abstract":"<div><h3>Background</h3><div>Increasing chronic disease incidence drives intravenous (IV) contrast-based diagnostic imaging. While IV procedure is largely safe, contrast-induced neuropathy risk in patients with predisposing factors demand pre-IV renal assessment. Although common, point-of-care creatinine (POC) tests are prone to generating ambiguous results. This frequently result in time-consuming retests, rescheduled appointments, patient distress, and healthcare burdens.</div></div><div><h3>Case Presentation</h3><div>A diabetic, hypertensive, and chronic kidney diseased Caucasian male, aged 61, presented for a scheduled intravenous contrast-enhanced computed tomography scan. His initial POC-based creatinine result of 1.20 mg/dL (106.1 μmol/L) narrowly exceeded the reference interval (0.67–––1.17 mg/dL [59.2 – 103.5 μmol/L]). Given the patient’s pre-existing conditions, laboratory-based creatinine test was performed to reassure his renal function. The new result was found to be 0.95 mg/dL (84 μmol/L), which fell within the normal reference interval. This substantial disparity of 0.25 mg/dL (22.1 μmol/L; 20.8 %) between creatinine tests while delaying the intravenous procedure prompted the clinicians to request an in-depth laboratory investigation.</div></div><div><h3>Conclusion</h3><div>Comprehensive analysis using patient-centered metrics such as index of individuality, reference change value, and subject-based reference interval alleviated the concerns on his renal health and disparity in assay results (&lt;0.3 mg/dL≡ &lt;26.5 μmol/L) total allowable error limit), thus allowing intravenous contrast imaging.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110979"},"PeriodicalIF":2.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674004","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":"DNA methylation levels are independently associated with prevalence of atherosclerotic cardiovascular disease in multifactorial chylomicronemia syndrome","authors":"Simon-Pierre Guay ,&nbsp;Martine Paquette ,&nbsp;Amélie Taschereau ,&nbsp;Véronique Desgagné ,&nbsp;Luigi Bouchard ,&nbsp;Sophie Bernard ,&nbsp;Alexis Baass","doi":"10.1016/j.clinbiochem.2025.110978","DOIUrl":"10.1016/j.clinbiochem.2025.110978","url":null,"abstract":"<div><h3>Background</h3><div>Multifactorial chylomicronemia syndrome (MCS) is a form of severe hypertriglyceridemia (sHTG) associated with increased risk of acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD). We recently reported suggestive evidence that DNA methylation (DNAm) contribute to the sHTG phenotype in MCS. While few predictors of acute pancreatitis were previously identified in MCS, predictors of ASCVD in MCS remain mostly unknown.</div></div><div><h3>Objective</h3><div>To study the factors associated with previous history of ASCVD in MCS patients.</div></div><div><h3>Methods</h3><div>A total of 114 patients with MCS were included in this retrospective study. Prevalence of ASCVD was determined at the baseline visit and defined as any atherosclerotic event: angina, myocardial infarction, coronary angioplasty, coronary bypass surgery, claudication, peripheral angioplasty, peripheral arterial surgery, transient ischemic attack, stroke, carotid endarterectomy, and artery stenosis (&gt;50 %). DNAm level at <em>ABCG1</em> (cg06500161), <em>CPT1A</em> (cg00574958), and <em>SREBF1</em> (cg11024682) candidate gene loci was quantified using pyrosequencing of bisulfite-treated DNA.</div></div><div><h3>Results</h3><div>Univariate analysis showed that age, <em>ABCG1</em> and <em>SREBF1</em> DNAm level, and the presence of obesity, hypertension, diabetes, and maximal TG level &gt; 40 mmol/L were associated with previous history of ASCVD. Multivariate analysis showed that age (OR 1.11 [1.04–1.18], p = 0.0006), <em>SREBF1</em> DNAm levels (OR 1.12 [1.03–1.24], p = 0.01), the presence of a maximal TG level &gt; 40 mmol/L (OR 0.13 [0.02–0.90], p = 0.04), and obesity (OR 3.32 [1.00–11.19, p = 0.05] were independently associated with history of ASCVD and explained 44.8 % of the variability in the prevalence of ASCVD (<em>p</em> &lt; 0.0001).</div></div><div><h3>Conclusion</h3><div>This study shows that <em>SREBF1</em> DNAm levels are independently associated with prevalence of ASCVD in MCS patients. It suggests that further studies of epivariations may contribute to better understand the clinical heterogeneity seen in MCS patients.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110978"},"PeriodicalIF":2.5,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144632509","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":"Low serum thyroglobulin level in A 15-year-old girl with papillary thyroid cancer and multiple neck lymph nodes: a case report","authors":"Nawroz Barwari,&nbsp;Alina-Gabriela Sofronescu","doi":"10.1016/j.clinbiochem.2025.110977","DOIUrl":"10.1016/j.clinbiochem.2025.110977","url":null,"abstract":"<div><h3>Background</h3><div>Papillary thyroid carcinoma (PTC) is the most common form of differentiated thyroid cancer. Serum thyroglobulin (Tg) is a key biomarker used in postoperative surveillance. However, discrepancies between Tg levels and disease burden may occur, complicating clinical assessment. The report herein proposes to discuss such a case.</div></div><div><h3>Case presentation</h3><div>We present a case of a 15-year-old girl with a history of total thyroidectomy for PTC (age 13) who developed a new vascular neck mass. Sonographic and cytologic evidence confirmed metastasis. Serum Tg levels (evaluated using concurrent immunoassays and liquid chromatography – tandem mass spectrometry) were detectable, but not proportional to the extent of disease burden, while the fine-needle aspirate (FNA) Tg levels were markedly elevated, consistent with metastatic disease.</div></div><div><h3>Discussion</h3><div>This case illustrates a phenomenon in which the degree of Tg elevation in serum is not proportional to the extent of metastatic disease. We discuss the analytical and biological factors that can contribute to this discordance and highlight the importance of multimodal monitoring strategies.</div></div><div><h3>Conclusion</h3><div>Clinicians should be aware that any detectable serum Tg in athyreotic patients indicates residual thyroid tissue or disease. However, this might not necessarily correlate well with the degree of metastatic disease. The integration of imaging, FNA cytology, and aspirate Tg measurement is essential for accurate disease assessment, particularly in cases with discordant laboratory findings.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110977"},"PeriodicalIF":2.5,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144641925","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":"Concentration dependent impact of hemolysis on lipase result: Does it clinically matter?","authors":"Janet R. Zhou ,&nbsp;Andrea Kunst ,&nbsp;Joshua E. Raizman ,&nbsp;Miranda Brun ,&nbsp;Yury Butorin ,&nbsp;Fahed A. Elian ,&nbsp;Lawrence de Koning ,&nbsp;Samantha Logan ,&nbsp;Isolde Seiden-Long ,&nbsp;Heather Paul ,&nbsp;Allison A. Venner ,&nbsp;Albert K.Y. Tsui","doi":"10.1016/j.clinbiochem.2025.110968","DOIUrl":"10.1016/j.clinbiochem.2025.110968","url":null,"abstract":"<div><h3>Background</h3><div>The hemolysis index (HI) interference threshold for the Roche lipase assay was recently decreased in the package insert from 1000 (10 g/L hemoglobin) to 100 (1 g/L hemoglobin), but limited data was provided to support the change. A decrease in the threshold could increase re-collection rates, disrupt laboratory workflow and change result interpretation. We performed interference studies to verify the new manufacturer HI claim at clinically relevant lipase concentrations.</div></div><div><h3>Methods</h3><div>Five lipase concentrations in lithium heparin plasma (36–227 U/L; n = 3–5) were spiked with hemolysates of varying hemoglobin concentrations (0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12 g/L). Lipase concentrations and HI were measured on the Roche Cobas c503 analyzer in triplicate and singleton, respectively, and means and standard deviations of replicates were calculated. Interference was quantified as the absolute and percent differences from the 0 g/L control, then compared against several published total allowable error (TEa) thresholds.</div></div><div><h3>Results</h3><div>At 1 g/L hemoglobin, the HI was 95 ± 4 and yielded a 0.4–1.0 % difference from baseline across all lipase concentrations. Depending on the TEa criteria used, the lowest lipase concentration group (38 ± 2 U/L) either exhibited significantly (p &lt; 0.05) elevated results starting at 3 g/L hemoglobin (HI = 289 ± 18) or no difference up to 12 g/L hemoglobin (HI = 1171 ± 22). All observed differences were within TEa limits for other lipase concentrations.</div></div><div><h3>Conclusion</h3><div>Hemolysis affected lipase results in a concentration-dependent manner with an analytically significant impact only at lipase concentrations &lt;40 U/L. This study stresses the importance of verifying new manufacturer claims and the value of assessing clinical change impact.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110968"},"PeriodicalIF":2.5,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571934","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}