Clinical biochemistry最新文献

{"title":"Defining a clinically relevant thyroglobulin antibody interference threshold for high-sensitivity thyroglobulin immunoassays: a single institution case study","authors":"Simmi Patel ,&nbsp;Octavia M. Peck Palmer ,&nbsp;Chanda B. Lay ,&nbsp;Kathleen Mulvey ,&nbsp;Michael R. Shurin ,&nbsp;Sarah E. Wheeler","doi":"10.1016/j.clinbiochem.2025.110995","DOIUrl":"10.1016/j.clinbiochem.2025.110995","url":null,"abstract":"<div><h3>Background</h3><div>The interpretation of serum thyroglobulin (Tg) levels in differentiated thyroid cancer is complicated by interference from thyroglobulin antibodies (TgAb) and there is no standardized threshold to determine interference. Following implementation of a new instrument, we observed increased TgAb-positive samples which reflex to alternate send-out Tg methods with reduced analytic sensitivity but which are more robust to TgAb interference. This resulted in fewer patients having detectable Tg for monitoring, longer turnaround times, and higher costs. We hypothesized that the TgAb assay limit of detection (LOD) was lower than the clinically meaningful interference threshold.</div></div><div><h3>Methods</h3><div>We analyzed 119 serum specimens with an electrochemiluminescent TgAb immunoassay (ECLIA-TgAb) ≥ 10 IU/mL, comparing TgAb measurements by radioimmunoassay (RIA-TgAb) and Tg levels measured via immunometric assay (IMA-Tg) and RIA (RIA-Tg; reference method), and clinical adjudication of discrepant samples.</div></div><div><h3>Results</h3><div>Of ECLIA-TgAb specimens above the LOD (10 IU/mL), 30 % were positive by RIA-TgAb. Increasing the ECLIA-TgAb threshold to 20 IU/mL improved concordance to 90 %. A 20 IU/mL threshold optimized qualitative agreement between IMA-Tg and RIA-Tg (95 %). Retrospective chart review of patient diagnosis and treatment indicated that there would be no change in patient management with the revised threshold.</div></div><div><h3>Conclusions</h3><div>We found that an ECLIA-TgAb threshold of 20 IU/mL allowed more patients to be followed by the high sensitivity IMA-Tg method with no change to clinical decision-making, reducing send-out testing by 66 %. This approach offers an accessible and practical strategy for individual laboratories to define clinically appropriate TgAb thresholds to maximize the samples eligible for highly sensitive Tg measurement.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110995"},"PeriodicalIF":2.1,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144888763","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":"Analytical performance and clinical evaluation of CL AIA-PACK® hs-E2, a high-sensitivity estradiol sandwich immunoassay using an anti-immunocomplex antibody","authors":"Satoshi Fujimura ,&nbsp;Yoko Usami ,&nbsp;Akari Yamamoto ,&nbsp;Nau Ishimine","doi":"10.1016/j.clinbiochem.2025.110993","DOIUrl":"10.1016/j.clinbiochem.2025.110993","url":null,"abstract":"<div><h3>Introduction</h3><div>The CL AIA-PACK® hs-E2 (hs-E2) is a high-sensitivity estradiol (E2) sandwich immunoassay employing an anti-immunocomplex antibody. This study aimed to evaluate its analytical performance and clinical utility at low concentration ranges relevant to aromatase inhibitor therapy and pediatric endocrinology, where accurate E2 measurement is clinically important.</div></div><div><h3>Methods</h3><div>The hs-E2 assay was evaluated for its precision, linearity, sensitivity, and interference. Its performance was compared with a conventional competitive immunoassay (Elecsys® E2) and liquid chromatography–tandem mass spectrometry (LC-MS/MS). Estradiol levels were measured in patients with estrogen receptor-positive breast cancer receiving selective estrogen receptor modulator or aromatase inhibitor therapy to assess clinical applicability.</div></div><div><h3>Results</h3><div>The assay showed excellent precision (CVs &lt; 6.4 %) and linearity across a broad concentration range. The limit of detection and limit of quantification were 4.84 and 7.11 pmol/L (10 % CV), respectively. Conjugated bilirubin induced a mild concentration-dependent decrease in measured E2 values. The hs-E2 assay showed a strong correlation with LC-MS/MS, even at low concentration ranges (r = 0.998), while Elecsys showed a weaker correlation below 147 pmol/L. In breast cancer patients, hs-E2 revealed significant differences in E2 levels across treatment groups, which were not detectable by the Elecsys assay.</div></div><div><h3>Conclusions</h3><div>The hs-E2 immunoassay using an anti-immunocomplex antibody exhibited superior analytical sensitivity and precision at low concentration ranges to conventional methods. Its strong agreement with LC-MS/MS and enhanced clinical discrimination support its utility in monitoring E2 levels in hormone-treated breast cancer patients and other low-E2 clinical conditions.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110993"},"PeriodicalIF":2.1,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144864118","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":"Gaps in guideline adherence: evaluating HLA-B*57:01 screening for abacavir sensitivity and the implementation of evidence-based HIV care","authors":"Lisa V. Kalman ,&nbsp;Yang Xia ,&nbsp;Ya-Lin A. Huang ,&nbsp;Kate Buchacz ,&nbsp;Rex Astles ,&nbsp;Jesse O’Shea","doi":"10.1016/j.clinbiochem.2025.110992","DOIUrl":"10.1016/j.clinbiochem.2025.110992","url":null,"abstract":"<div><h3>Objective</h3><div>Approximately 5–8 % of the population carries the <em>HLA-B*57:01</em> allele, which increases the risk of severe hypersensitivity reactions to abacavir. Current guidelines and an FDA black box warning recommend <em>HLA-B*57:01</em> screening for all patients before starting abacavir. We assessed the proportion of patients who undergo screening before initiating abacavir to evaluate adherence to guidelines.</div></div><div><h3>Design</h3><div>A retrospective cohort study using national IQVIA® PharMetrics Plus reimbursement data.</div></div><div><h3>Methods</h3><div>Data from the 2014-2022 IQVIA® PharMetrics Plus March 2023 dataset were analyzed. We identified patients aged ≥ 18 years who were newly prescribed abacavir, with ≥ 12 months of continuous enrollment before their first abacavir prescription. We examined the proportion of individuals who received <em>HLA-B*57:01</em> screening any time before their initial abacavir prescription and conducted a multivariable logistic regression analysis on the receipt of <em>HLA-B*57:01</em> screening adjusting for sex, age, year, and region.</div></div><div><h3>Results</h3><div>We identified 7,391 patients newly prescribed abacavir between 2014 and 2022. Approximately 46 % received an <em>HLA-B*57:01</em> screen before initiation of abacavir. Annual screening rates ranged from 44 % to 50 % between 2015 and 2018 and dropped to 17 % by 2022. Screening was less likely to occur after 2018, compared to earlier in the study period, and more likely for younger as well as male patients.</div></div><div><h3>Conclusions</h3><div>These findings highlight broader challenges in HIV guideline adherence, emphasizing the need for ongoing evaluation and systematic interventions to improve implementation and patient safety.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110992"},"PeriodicalIF":2.1,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882221","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":"Ionized magnesium—the forgotten strong ion in pediatric critical care","authors":"Guido Filler","doi":"10.1016/j.clinbiochem.2025.110991","DOIUrl":"10.1016/j.clinbiochem.2025.110991","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110991"},"PeriodicalIF":2.1,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871654","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":"Capillary electrophoresis mis-anchoring in a case of Hb Hope with HbE","authors":"Victoria Higgins ,&nbsp;Natalia Volodko ,&nbsp;Michelle L. Parker ,&nbsp;Mathew P. Estey ,&nbsp;Dustin Proctor ,&nbsp;Lily Olayinka ,&nbsp;Ashley Newbigging ,&nbsp;Pierre Bordeleau ,&nbsp;Maggie Powell","doi":"10.1016/j.clinbiochem.2025.110990","DOIUrl":"10.1016/j.clinbiochem.2025.110990","url":null,"abstract":"<div><h3>Background</h3><div>Capillary electrophoresis is a widely used method for hemoglobin (Hb) fraction separation and relative quantitation, where pre-defined Hb peaks (typically HbA and HbA2) act as reference points to “anchor” the electropherogram and define migration zones. In cases lacking HbA or involving variants with migration patterns similar to HbA or HbA2, mis-anchoring can occur–leading to incorrect zoning of Hb variants. This presents a diagnostic challenge, where follow-up investigations, often including molecular testing, are required to establish an accurate diagnosis.</div></div><div><h3>Case Report</h3><div>We report a case of a 43-year-old Thai female who underwent hemoglobinopathy investigation for microcytic anemia. Capillary electrophoresis showed peaks in the HbA (70.8%), HbA2 (24.4%), and HbC (2.9%) zones, as well as two small peaks in the Z11 (0.9%) and HbD (1.0%) zones. Gel electrophoresis at acid pH showed a band in the HbA position and one slightly anodal to the HbF position and at alkaline pH showed a band in the HbC/E position and another slightly anodal to the HbA position. HBB sequencing identified heterozygosity for the pathogenic HbE and clinically benign Hb Hope variants. HBA PCR detected a single alpha globin gene deletion (αα/α-3.7), consistent with alpha thalassemia silent carrier. Reinterpretation of the electropherogram showed that Hb Hope and HbE mis-anchored as HbA and HbA2, respectively, due to their similar migration deltas.</div></div><div><h3>Conclusion</h3><div>This is the first documented case of compound heterozygosity for Hb Hope and HbE characterized by capillary electrophoresis. It highlights how beta chain variants with similar migration spacing to HbA and HbA2 can mis-anchor, emphasizing the need for molecular testing when results are unclear. Definitive testing helps avoid diagnostic misclassification and ensure accurate interpretation in complex hemoglobinopathy cases.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110990"},"PeriodicalIF":2.1,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144852625","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":"Critical role of laboratory and multidisciplinary strategies in the early diagnosis of acquired haemophilia a for life-saving management","authors":"R. Belardi ,&nbsp;M. Emili ,&nbsp;F.G. Viola ,&nbsp;S. Velocci ,&nbsp;M. Baldetti ,&nbsp;M. Minieri ,&nbsp;M. Pieri ,&nbsp;E. Picchi ,&nbsp;D. Morosetti ,&nbsp;S. Bernardini ,&nbsp;A. Terrinoni","doi":"10.1016/j.clinbiochem.2025.110988","DOIUrl":"10.1016/j.clinbiochem.2025.110988","url":null,"abstract":"<div><h3>Background</h3><div>Acquired haemophilia A (AHA) is a rare but potentially life-threatening autoimmune disorder characterized by the development of autoantibodies against coagulation factor VIII (FVIII). It manifests with spontaneous, severe bleeding in patients without a personal or family history of bleeding disorders. Early recognition and rapid treatment are crucial to reduce morbidity and mortality.</div></div><div><h3>Case presentation</h3><div>Here we describe two cases of AHA in elderly female patients with no prior history of coagulopathy. The first case involved an 81-year-old woman presenting with extensive spontaneous haematomas and severe anaemia. Laboratory findings revealed an isolated prolonged activated partial thromboplastin time (aPTT), undetectable FVIII activity, and the presence of a low-titre FVIII inhibitor (2.24 BU/mL). Treatment with recombinant activated factor VII (rFVIIa) and corticosteroids led to clinical improvement and inhibitor reduction. The second case concerned an 85-year-old woman who developed severe haemorrhagic manifestations following ureteric stenting. Coagulation studies showed markedly prolonged aPTT and a high-titre FVIII inhibitor (165 BU/mL). Despite initiation of immunosuppressive therapy the patient experienced fatal complications due to uncontrolled bleeding and multi-organ failure.</div></div><div><h3>Conclusions</h3><div>These cases underscore the importance of considering a possible AHA in patients with isolated aPTT prolongation and unexplained bleeding. Punctual laboratory diagnosis, including mixing studies and FVIII inhibitor assays, is essential for early life-saving interventions. Multi-disciplinary management and rapid initiation of haemostatic and immunosuppressive therapies are key to improving outcomes in this challenging condition.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110988"},"PeriodicalIF":2.1,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144862160","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":"Diagnostic value of serum TSI levels in Graves’ disease and direct comparison of diagnostic performance with TRAb: A systematic review and meta-analysis","authors":"Ziyue Jiang ,&nbsp;Shouxia Li ,&nbsp;Li Yang ,&nbsp;Xuedong Song ,&nbsp;Xiaofang Zhang ,&nbsp;Lili Guo ,&nbsp;Jia Guo ,&nbsp;Haili Zhang ,&nbsp;Dingli Chen","doi":"10.1016/j.clinbiochem.2025.110989","DOIUrl":"10.1016/j.clinbiochem.2025.110989","url":null,"abstract":"<div><div>This study aimed to systematically assess the diagnostic value of thyroid-stimulating immunoglobulin on the Siemens Immulite platform (the TSI assay) and to conduct a direct comparison with thyrotropin receptor antibodies on the Roche cobas platform (the TRAb assay) for the diagnosis of Graves’ disease (GD). We performed systematic literature searches across multiple databases. Following strict screening, we identified 20 eligible clinical studies that evaluated the diagnostic value of the TSI assay, either alone or in comparison with the TRAb assay. Using random-effects models, we calculated pooled estimates of sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR). Diagnostic accuracy was further evaluated through summary receiver operating characteristic curve analysis. The findings revealed that the TSI assay demonstrated excellent diagnostic accuracy, with pooled SEN of 0.933 (95 % CI: 0.924 − 0.941), SPE of 0.961 (95 % CI: 0.956 − 0.964), PLR of 24.078 (95 % CI: 16.727 − 34.659), NLR of 0.036 (95 % CI: 0.020 − 0.066), and DOR of 778.29 (95 % CI: 343.45 − 1763.67), supported by an area under the curve (AUC) of 0.9919. In direct comparison to the TRAb assay, the TSI assay showed slightly better SEN (0.967 vs. 0.889), DOR (1310.03 vs. 692.73), and NLR (0.023 vs. 0.046), comparable SPE (0.964 vs. 0.959) and PLR (29.954 vs. 30.066), and higher AUC (0.9963 vs. 0.9899). These results conclusively demonstrate that the TSI assay shows high sensitivity and specificity in the diagnosis of GD, exceeding or at least comparable to TRAb, making it a valuable tool for clinical diagnosis.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110989"},"PeriodicalIF":2.1,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810234","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":"Best practice guidelines on reference interval harmonization in Canada: Evidence-based recommendations from the CSCC working group on reference interval harmonization (CSCC WG-hRI)","authors":"Mary Kathryn Bohn ,&nbsp;Dana Nyholt ,&nbsp;Cynthia Balion ,&nbsp;George Cembrowski ,&nbsp;Christine Collier ,&nbsp;Vincent De Guire ,&nbsp;Victoria Higgins ,&nbsp;Benjamin Jung ,&nbsp;Olivia Landon ,&nbsp;Zahraa Mohammed-Ali ,&nbsp;David Seccombe ,&nbsp;Jennifer Taher ,&nbsp;Albert K.Y. Tsui ,&nbsp;Allison A. Venner ,&nbsp;Nicole White Al-Habeeb ,&nbsp;Khosrow Adeli","doi":"10.1016/j.clinbiochem.2025.110986","DOIUrl":"10.1016/j.clinbiochem.2025.110986","url":null,"abstract":"<div><div>Unnecessary variation in reference intervals across clinical laboratories increases the risk of inconsistent or misinformed clinical decision-making. Development of harmonized or common reference intervals for assays that demonstrate minimal bias across measurement procedures and laboratories is an important step towards standardized quality healthcare. The aim of this document is to recommend evidence-based harmonized reference intervals for routine clinical laboratory tests that can be implemented in hospital and community settings across Canada. The approach that was taken for these recommendations included several important steps. Candidate analytes for harmonization were selected based on documented traceability and external quality assessment performance. Two years of patient test result data for 16 routine clinical chemistry analytes were extracted from four provincial community laboratories across Canada. A robust indirect statistical algorithm was applied to assess the feasibility of harmonization and harmonized reference intervals were established for appropriate analytes. Derived harmonized reference intervals were compared to existing data from healthy individuals from Canadian and international studies. All recommended harmonized reference intervals were verified across nine Canadian laboratories that included all main manufacturers using serum and plasma samples collected from 60 healthy volunteers. Based on our findings, evidence-based harmonized reference intervals are recommended for 13 analytes, including: albumin (bromocresol green method only), alanine aminotransferase (ALT) with and without pyridoxal 5′-phosphate, alkaline phosphatase (ALP), calcium, carbon dioxide (total), chloride, creatinine, lactate dehydrogenase (LDH), phosphate, potassium (serum only), magnesium, total protein, and thyroid stimulating hormone (TSH). These recommendations will support national harmonization of laboratory reference intervals with the goal of improving and standardizing clinical decision-making and patient care across Canada.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110986"},"PeriodicalIF":2.1,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788387","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 ,&nbsp;Gloria Oiyahumen Anetor ,&nbsp;Joseph Chigbogu Nwobi ,&nbsp;Godwin Osaretin Igharo ,&nbsp;Anuoluwapo Victor Adeyemi ,&nbsp;Tony Badrick ,&nbsp;John Ibhagbemien Anetor","doi":"10.1016/j.clinbiochem.2025.110985","DOIUrl":"10.1016/j.clinbiochem.2025.110985","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110985"},"PeriodicalIF":2.1,"publicationDate":"2025-08-04","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 ,&nbsp;Nolan Pellecuier ,&nbsp;Sandrine Dabernat ,&nbsp;Fouzi Mestari ,&nbsp;Brigitte Colombiès ,&nbsp;Emmanuel Richard ,&nbsp;Rana Alkouri ,&nbsp;Dominique Bonnefont-Rousselot ,&nbsp;Benoit Rucheton ,&nbsp;Marie-Lise Bats","doi":"10.1016/j.clinbiochem.2025.110983","DOIUrl":"10.1016/j.clinbiochem.2025.110983","url":null,"abstract":"<div><h3>Background and aims</h3><div>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.</div></div><div><h3>Materials and methods</h3><div>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).</div></div><div><h3>Results</h3><div>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 &gt;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 &gt;0.50 g/L.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 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}