Clinical biochemistry最新文献

{"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}

{"title":"HFE related acute porphyria-like attack induced by severe influenza A pneumonia","authors":"Hongmei Yang,&nbsp;Jianxing Guo,&nbsp;Guowei Ye,&nbsp;Dongxia Wang,&nbsp;Yimin Yang","doi":"10.1016/j.clinbiochem.2025.111023","DOIUrl":"10.1016/j.clinbiochem.2025.111023","url":null,"abstract":"<div><div>This case report describes a patient with <em>HFE</em>-related acute porphyria-like attack triggered by severe influenza A pneumonia. The patient was admitted with fever, dyspnea, and abdominal pain and was diagnosed with severe influenza A pneumonia, acute respiratory failure, and septic shock. On the third day of hospitalization, the patient developed profound shock requiring mechanical ventilation and tested positive for influenza A virus. During treatment, significant liver dysfunction was observed, along with clinical manifestations including abdominal pain, loss of consciousness, and bilateral strabismus, suggesting neurological involvement. The diagnosis of acute porphyria-like attack was confirmed by positive urine porphobilinogen testing and genetic detection of a <em>HFE^H63D</em> mutation. This case highlights the importance of maintaining a high index of suspicion for porphyrin metabolism dysfunction in critically ill patients, particularly in the setting of infection or other precipitating factors. Timely diagnosis and management can significantly improve patient outcomes. These findings provide new insights into the clinical recognition of porphyria, especially in critically ill patients, and underscore the importance of multidisciplinary collaboration and meticulous diagnostic evaluation.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111023"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312149","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":"Assessment of structural and functional characteristics of HDL and LDL in lung cancer patients in order to elucidate mechanisms of cholesterol metabolic pathways disorders","authors":"Milica Belic ,&nbsp;Dragana Jovanovic ,&nbsp;Milica Miljkovic Trailovic ,&nbsp;Miron Sopic ,&nbsp;Marina Roksandic-Milenkovic ,&nbsp;Vesna Ceriman Krstic ,&nbsp;Nemanja Dimic ,&nbsp;Jelena Vekic ,&nbsp;Aleksandra Zeljkovic ,&nbsp;Jelena Kotur-Stevuljevic","doi":"10.1016/j.clinbiochem.2025.111012","DOIUrl":"10.1016/j.clinbiochem.2025.111012","url":null,"abstract":"<div><h3>Introduction</h3><div>Cholesterol metabolism dysregulation is recognized as one of the hallmarks of the cancer with highest mortality rate and the second most common malignancy – lung cancer (LC). LDL and HDL particles, the latter being carriers of the antioxidant paraoxonase-1 (PON1), were already proven to be altered in cancer patients. We have tried to investigate in more depth the cholesterol metabolism perturbances in LC, by analzying content of each of the LDL and HDL subclass and (anti)oxidative activity of each of the HDL subclass separately.</div></div><div><h3>Materials and Methods</h3><div>LDL and HDL subclasses from blood samples of 89 LC patients and 84 healthy subjects were separated and HDL subclasses PON1 activity assessed using Rainwater method and Gugliucci’s zymogram method, respectively.</div></div><div><h3>Results</h3><div>LC patients had higher relative proportion of HDL 2 particles, lower proportion of HDL 3 particles, and significantly lower activity of PON1 compared to control group (CG). Relative proportion of PON1 activity was higher on HDL 2b fraction and lower on all HDL 3 fractions of LC patients compared to CG. Relative proportions of LDL I and LDL II particles were increased, while proportions of LDL IV and small dense LDL particles were decreased in LC patients. Relative proportions of HDL and LDL subfractions and PON1 activities on HDL subfractions were found to be dependent on LC type and size, number of comorbidities and sites of progression, and overall response to therapy.</div></div><div><h3>Conclusion</h3><div>PON1 activity and lipoprotein subfractions distribution seem to be indicators of possible metabolic pathways (disorders) in LC.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111012"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145057324","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":"How effective is serum FGL1 measurement in assessing disease activity: A cross-sectional study in rheumatoid arthritis","authors":"Mesut Ates ,&nbsp;Merve Ates ,&nbsp;Mujgan Gurler ,&nbsp;Murat Tasci ,&nbsp;Ozgur Mehmet Yis","doi":"10.1016/j.clinbiochem.2025.111005","DOIUrl":"10.1016/j.clinbiochem.2025.111005","url":null,"abstract":"<div><h3>Introduction</h3><div>In rheumatoid arthritis, which is an autoimmune inflammatory disease with multisystemic involvement, especially the joints, tracking disease activity is quite valuable in order to improve the quality of life of patients and to develop individualized treatment strategies. In this study, we evaluated the role of Fibrinogen-Like Protein 1 (FGL1), which has recently been shown to be associated with various rheumatological and autoimmune diseases, in disease diagnosis and activity in rheumatoid arthritis (RA).</div></div><div><h3>Material and Methods</h3><div>In this prospective study consisting of 108 RA patients divided into two groups as low disease activity-remission group (LDA) and moderate-high disease activity group (MHA) according to the Disease Activity Score 28-C-reactive protein score and 56 controls, serum FGL1 level was measured by Enzyme Linked ImmunoSorbent Assay (ELISA).</div></div><div><h3>Results</h3><div>Serum FGL1 level was found to be statistically significantly higher in RA patients compared to the control group, and in the MHA group compared to the LDA group. The mean FGL1 level was determined as 805.37 ng/ml in the LDA group, 1055.5 ng/ml in the MHA group and 652.31 ng/ml in the control group (p &lt; 0.001). There was a positive correlation between FGL1 level and CRP, Erythrocyte Sedimentation Rate (ESR), CRP/Albumin levels.</div></div><div><h3>Conclusions</h3><div>Increased serum FGL1 levels were found to increase the likelihood of identifying patients with moderate-to-high disease activity RA. FGL1 is also effective in evaluating disease activity when used together with other inflammation markers, especially CRP/Albumin.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111005"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144921991","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":"Assessment of serum sST2 for cardiac involvement in idiopathic inflammatory myopathies","authors":"Liubing Li ,&nbsp;Ying Yuan ,&nbsp;Siting Yi ,&nbsp;Tangdan Ding ,&nbsp;Hongji Zhu ,&nbsp;Qiong Shi ,&nbsp;Hongxia Tan ,&nbsp;Runzhao Li ,&nbsp;Yuheng Liu ,&nbsp;Hongxu Xu ,&nbsp;Min Liu ,&nbsp;Dong Wang ,&nbsp;Ruizhi Wang","doi":"10.1016/j.clinbiochem.2025.111037","DOIUrl":"10.1016/j.clinbiochem.2025.111037","url":null,"abstract":"<div><h3>Objective</h3><div>To assess the diagnostic performance of soluble growth stimulation-expressed gene 2 (sST2) for cardiac involvement in patients with idiopathic inflammatory myopathies (IIMs).</div></div><div><h3>Methods</h3><div>From a cohort of 237 patients with IIMs, 86 were finally included and 18 exhibited cardiac involvement. The comparison of demographic, clinical, and laboratory parameters between IIM patients with and without cardiac involvement was conducted. Additionally, independent predictors for cardiac involvement and the diagnostic performance of sST2 were analyzed.</div></div><div><h3>Results</h3><div>The prevalence of cardiac involvement in IIMs was 20.9 %. The medians (interquartile range, IQR) of sST2 (65.6 [33.7–92.9] <em>vs.</em> 14.5 [7.8–25.4] μg/L) and N-terminal B-type pro-natriuretic peptide (NTproBNP, 120.2 [65.5–324.1] <em>vs.</em> 44.0 [16.8–104.6] ng/L) were significantly elevated in IIM patients with cardiac involvement compared with those without cardiac involvement. Multivariable logistic regression showed elevated levels of sST2 (OR = 3.936, 95 % CI 1.808–8.571, <em>P =</em> 0.001) and NTproBNP (OR = 2.308, 95 % CI 1.302–4.093, <em>P =</em> 0.004) were risk factors for cardiac involvement in IIM patients. The combined receiver operating characteristic (ROC) analysis of sST2 and NTproBNP indicated high diagnostic values in distinguishing IIM patients with cardiac involvement from those without cardiac involvement, with 94.4 % (95 % CI 72.2 %–99.7 %) sensitivity, 87.3 % (95 % CI 76.9 %–93.4 %) specificity, and 0.926 area under the ROC curve (95 % CI 0.840–1.000, <em>P</em> &lt; 0.001).</div></div><div><h3>Conclusion</h3><div>sST2 serves as a valuable biomarker for detecting cardiac involvement in patients with IIMs.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111037"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145430371","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":"Re-evaluating ferritin thresholds to diagnose iron deficiency","authors":"Katie M. Troike,&nbsp;Adam J. McShane","doi":"10.1016/j.clinbiochem.2025.111020","DOIUrl":"10.1016/j.clinbiochem.2025.111020","url":null,"abstract":"<div><h3>Background</h3><div>Iron deficiency (ID) and iron deficiency anemia (IDA) are prevalent and treatable conditions which disproportionately affect women. Serum ferritin is the most sensitive biomarker for ID and IDA, but its utility in clinical decision making is limited by sex-specific reference intervals (RIs) that are frequently lower than evidence-based recommendations. The inclusion of asymptomatic, iron-depleted individuals in RI studies likely accounts for inappropriate ferritin thresholds, and a lower cutoff of 30 µg/L has been proposed by an expert consensus panel to improve sensitivity.<!--> <!-->In this study, we assessed ferritin RIs for diagnosing ID and IDA in our patient population.</div></div><div><h3>Methods</h3><div>Patient data, including age, sex assigned at birth, hemoglobin, and iron markers, were extracted from the laboratory information system (LIS). Patients were stratified into iron replete (IR), ID, or IDA groups based on measurements for iron, transferrin saturation, and hemoglobin. Ferritin values from the IR group were used to generate new reference ranges and receiver operator characteristic (ROC) curves were plotted to define optimal ferritin cutoffs for diagnosis of ID and IDA.</div></div><div><h3>Results</h3><div>Ferritin RIs generated from the IR group had lower limit cutoffs of 16.9 µg/L and 30 µg/L for females and males, respectively. Youden Index analysis of ROC curves identified optimal cutoffs of 45 µg/L and 70 µg/L for ID in females and males, respectively, improving diagnostic sensitivity by 44 % in the female group.</div></div><div><h3>Conclusions</h3><div>These findings are consistent with recommendations for increasing ferritin cutoffs and demonstrate the need for clinical laboratories to re-examine ferritin RIs, particularly for ID diagnosis in the female patient population.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111020"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205646","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":"Diagnosis of patients with IgM monoclonal gammopathy due to analytical interference","authors":"Ricardo Rubio-Sánchez ,&nbsp;Alberto Izquierdo-Martínez ,&nbsp;Sara Martínez-Rodríguez ,&nbsp;Lucia Mezquita Romero ,&nbsp;José Ángel Noval-Padillo ,&nbsp;Daniel Fatela-Cantillo ,&nbsp;Juan M. Guerrero","doi":"10.1016/j.clinbiochem.2025.111033","DOIUrl":"10.1016/j.clinbiochem.2025.111033","url":null,"abstract":"<div><h3>Introduction</h3><div>Blood hyperviscosity is a condition associated, in most cases, with Waldenström’s macroglobulinemia (WM) and other plasma cell dyscrasias, primarily due to the pentameric structure of immunoglobulin (Ig) M. Analytical interference in the determination of alanine aminotransferase with the Abbott Alinity c assay has recently been documented, related to increased blood viscosity as a result of a monoclonal component. The detection of this interference indicates a significant and isolated increase in the concentration of a single immunoglobulin, leading to the diagnosis of a previously unknown monoclonal gammopathy.</div></div><div><h3>Case description</h3><div>Thanks to the described interference and the expansion of analytical testing by the clinical laboratory, 15 patients with a previously unknown IgM monoclonal component were identified over 7 months. IgM levels ranged from 8.37 g/L, with a monoclonal component of 2.4 g/L, to 82.43 g/L, with a monoclonal component of 40.9 g/L. Ten patients were diagnosed with IgM monoclonal gammopathy of undetermined significance, one with asymptomatic biclonal gammopathy, and one with WM who presented with hyperviscosity syndrome, requiring plasmapheresis and treatment with rituximab-bendamustine.</div></div><div><h3>Discussion</h3><div>These cases highlight the importance of investigating laboratory test interferences, as they may be related to subclinical pathologies, such as monoclonal gammopathies. Detecting this interference and expanding laboratory testing can detect the pathology even before the appearance of related symptoms. This early identification allows for patient referral to the Hematology Department for appropriate follow-up, improving the prevention of complications and helping to make more timely therapeutic decisions.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111033"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145430376","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}