Journal of Applied Laboratory Medicine最新文献

{"title":"Performance Evaluation of an Automated Neurofilament Light Chain Immunoassay.","authors":"Sarmistha Ray, Rana Fayyad, Sascha Lange, Charbel Abou-Diwan, Petra Kukkaro, Dieter A Häring, Matthew Gee, JoDell E Wilson, Eddine Merabet","doi":"10.1093/jalm/jfag041","DOIUrl":"https://doi.org/10.1093/jalm/jfag041","url":null,"abstract":"<p><strong>Background: </strong>Increased neurofilament light chain (NfL) in cerebrospinal fluid and blood indicates recent neuroinflammatory damage and is prognostic of disease worsening (JAMA Neurol 2023;80:1317-25). These studies evaluate the analytical performance of the Siemens Healthineers Atellica IM NfL assay, testing serum and plasma, on the Atellica IM analyzer.</p><p><strong>Methods: </strong>Detection capability, linearity, dilution recovery, precision, interfering substance testing, specimen equivalence, method comparison studies, and determination of expected values are all described and performed according to CLSI standards.</p><p><strong>Results: </strong>The limit of blank, detection, and quantitation were 1.5, 2.0, and 3.0 pg/mL, respectively. The analytical measuring interval was 3.0 to 300.0 pg/mL with on-board dilutions extending the reportable range to 3000 pg/mL. Repeatability and within-lab precision ranged from 0.9% to 5.7% CV and 1.5% to 8.6% CV, respectively. No significant interference was detected for biotin or 38 other substances. Serum SST and plasma EDTA samples provided equivalent NfL results. Comparison of the NfL assay across Siemens Healthineers platforms (Atellica IM, ADVIA Centaur XP/XPT systems) showed strong alignment; the Atellica IM NfL assay also strongly aligns to the early phase certified reference material (Clin Chem Lab Med 2023;61:1245-54). Age-specific expected values for healthy adults were provided, with an overall central 95th percentile range of 3.7 to 18.9 pg/mL.</p><p><strong>Conclusion: </strong>The Siemens Healthineers Atellica IM NfL assay demonstrated strong performance in all categories of assay development and verification; importantly, results from both healthy and multiple sclerosis patients fall within the reportable range. The Atellica IM NfL assay is for in vitro diagnostic use in the quantitative measurement of NfL in human serum and plasma (EDTA) using the Atellica IM analyzer.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reference Intervals and Clinical Determinants of Blood Thrombogenicity in Antithrombotic Drug-Naïve Adults Using an Advanced Microchip-Based Device.","authors":"Takeaki Kudo, Yunosuke Matsuura, Michikazu Nakai, Shohei Koyama, Hironao Iwakiri, Yoshisato Shibata, Koichi Kaikita","doi":"10.1093/jalm/jfag042","DOIUrl":"https://doi.org/10.1093/jalm/jfag042","url":null,"abstract":"<p><strong>Background: </strong>The Total Thrombus-formation Analysis System 01 (T-TAS 01) is an advanced microchip-based device that enables quantitative assessment of blood thrombogenicity. However, broader clinical implementation remains limited by the lack of well-established reference intervals (RIs) in healthy, antithrombotic drug-naïve individuals. This study aimed to define RIs and identify clinical determinants of blood thrombogenicity in antithrombotic drug-naïve adults using T-TAS 01.</p><p><strong>Methods: </strong>Blood thrombogenicity was measured using T-TAS 01 in 319 adults without antithrombotic therapy who underwent health checkups at the Miyakonojo Health Service Center. The T-TAS 01 parameters, PL18-AUC10 and AR10-AUC30, were calculated as the areas under the flow-pressure curves of the PL-chip (type I collagen-coated) and the AR-chip (type I collagen and tissue factor-coated), respectively. Their associations with clinical parameters were assessed using multivariate regression analysis.</p><p><strong>Results: </strong>The median age was 46.0 years; 64.3% of participants were female, and 82.1% had no hypertension, dyslipidemia, or diabetes. The median platelet count was 247 × 109/L. The median PL18-AUC10 and AR10-AUC30 values were 392.3 and 1335.9, with RIs of 236.3 to 468.1 and 1010.0 to 1496.2, respectively. PL18-AUC10 was independently associated with white blood cell count (coefficient, 5.15; 95% CI, 0.88-9.41) and platelet count (0.36; 95% CI, 0.25-0.47), whereas AR10-AUC30 was independently associated with body mass index (4.06; 95% CI, 0.06-8.06), platelet count (0.79; 95% CI, 0.52-1.06), and γ-glutamyl transpeptidase (-0.54; 95% CI, -0.90 to -0.18).</p><p><strong>Conclusions: </strong>Our findings provide foundational reference data for the clinical application of T-TAS 01 and support its potential as a point-of-care tool for individualized assessment of thrombogenicity.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147700170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on Unraveling a Clinical Coagulation Paradox: The Laboratory's Investigative Role.","authors":"Joesph R Wiencek","doi":"10.1093/jalm/jfag045","DOIUrl":"https://doi.org/10.1093/jalm/jfag045","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147692838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unraveling a Clinical Coagulation Paradox: The Laboratory's Investigative Role.","authors":"Filomena G R Viola, Elisa Innocenzi, Angelina La Becca, Azzurra Ciammariconi, Sergio Bernardini","doi":"10.1093/jalm/jfag017","DOIUrl":"https://doi.org/10.1093/jalm/jfag017","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147692902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Samples for the Determination of Total 25-Hydroxyvitamin D Levels Were Stable at Ambient Temperature.","authors":"Edmund H Wilkes, Alexander Ross, Emma L Williams","doi":"10.1093/jalm/jfag034","DOIUrl":"https://doi.org/10.1093/jalm/jfag034","url":null,"abstract":"<p><strong>Background: </strong>Vitamin D holds important roles in human physiology, and deficiency of this vitamin is of worldwide clinical significance. Serum levels of 25-hydroxyvitamin D (25-OHD) are currently the most appropriate indicator of vitamin D status in the majority of individuals, and thus its preanalytical stability and accurate measurement in clinical laboratories are of significant interest.</p><p><strong>Methods: </strong>We analyzed previously published data from the Vitamin D Standardization Programme commutability study and 2 further datasets: one retrospective observational study and one prospective experiment exploring additional aspects of 25-OHD stability. We analyzed each dataset through the use of robust Bayesian multilevel linear models using the {brms} package in the R statistical computing environment.</p><p><strong>Results: </strong>Our analyses provided evidence that 25-OHD was stable when shipped at ambient temperature, as the average difference between shipping at frozen vs ambient temperature on total 25-OHD measurements across multiple methods, laboratories, and samples [with assigned values ranging from 12.1 to 41.4 ng/mL (30.2-103.6 nmol/L)] was -0.3 ng/mL [-0.8 nmol/L; 95% credible interval (CI) -3.5-1.7 nmol/L]. Our analyses of orthogonal datasets corroborated these findings, with the estimated difference of storage for 7 days at ambient vs frozen temperature prior to shipping being 0.4 ng/mL (0.9 nmol/L; 95% CI 0.1-1.9 nmol/L).</p><p><strong>Conclusions: </strong>The data and analyses we present here provide substantial evidence to support 25-OHD stability when shipped at ambient temperature and thus support the continuation of this practice as part of the Vitamin D External Quality Assurance Scheme (DEQAS) quality program.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147624113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effective Removal of Calcium Dobesilate Interference in Triglyceride Measurement Using Copper Oxide.","authors":"Meng Zhao, Jiabao Fan, Panpan Lv, Zhengqi Zhu, Zhen Zhao","doi":"10.1093/jalm/jfag011","DOIUrl":"https://doi.org/10.1093/jalm/jfag011","url":null,"abstract":"<p><strong>Background: </strong>Calcium dobesilate (CD), a vasoprotective drug, has been reported to cause substantial negative interference in enzymatic triglyceride (TG) assays, compromising result accuracy. This study aimed to quantify the extent of CD-induced bias in TG measurement and to evaluate whether copper oxide (CuO) pretreatment could effectively eliminate this interference.</p><p><strong>Methods: </strong>Serum samples with TG concentrations of 1.76 and 5.61 mmol/L (156 mg/dL and 497 mg/dL) were spiked with CD at 2-64 μg/mL and analyzed on the Roche cobas c701 system. To assess the corrective capability of CuO, 0.1 g of CuO was added prior to measurement. Percentage biases in TG results, with and without CuO pretreatment, were compared to evaluate interference and correction efficiency.</p><p><strong>Results: </strong>CD markedly reduced TG measurement values, particularly at lower TG concentrations, resulting in biases exceeding the clinically acceptable limit. When the TG concentration was 1.76 mmol/L (156 mg/dL), the addition of 0.1 g CuO decreased CD-induced biases from -0.56% to -0.18%, -2.45% to -0.36%, -5.49% to -0.15%, -8.96% to -1.84%, -16.65% to 0.41%, and -29.79% to -2.27%, respectively, at CD concentrations of 2, 4, 8, 16, 32, and 64 μg/mL. A similar correction was observed at 5.61 mmol/L TG (497 mg/dL), where biases were reduced from -0.93% to -0.45%, -1.98% to 1.00%, -2.97% to -2.13%, -4.71% to -2.18%, -12.16% to -1.79%, and -17.92% to -0.65%, respectively.</p><p><strong>Conclusions: </strong>CuO pretreatment effectively mitigates CD-induced negative interference in enzymatic TG assays, restoring measurement accuracy. This simple, low cost, and clinically practical approach provides a reliable solution for accurate TG monitoring in patients receiving CD therapy.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Diagnostic Odyssey in a Family with Multiple Osteochondromas.","authors":"Yan Xu, Niu Li, Jian Wang, Yanlin Wang, Shuyuan Li","doi":"10.1093/jalm/jfag038","DOIUrl":"https://doi.org/10.1093/jalm/jfag038","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147533491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on A Diagnostic Odyssey in a Family with Multiple Osteochondromas.","authors":"Benjamin E Kang","doi":"10.1093/jalm/jfag046","DOIUrl":"https://doi.org/10.1093/jalm/jfag046","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147533554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay.","authors":"Marko Knoll, Lori B Daniels, Christian Mueller, Nicholas L Mills, Evangelos Giannitsis, Alisa F A Rösser, Dunja Kurtoic, Annika Wahl, Richard Body, Robert H Christenson, Christa Cobbaert, Christopher R deFilippi, Kai M Eggers, Kenji Inoue, Allan S Jaffe, Cian P McCarthy, James McCord, Johannes T Neumann, Torbjørn Omland, Cynthia Papendick, Yader Sandoval, Jack Wei Chieh Tan, Martin P Than, Raphael Twerenbold, W Frank Peacock, Steven J R Meex","doi":"10.1093/jalm/jfag031","DOIUrl":"https://doi.org/10.1093/jalm/jfag031","url":null,"abstract":"<p><strong>Background: </strong>High-sensitivity cardiac troponin (hs-cTn) assays are recommended for the diagnosis of acute myocardial infarction. Here, we characterize the analytical performance of a next-generation hs-cTn assay, Elecsys® Troponin T hs Gen 6 (Roche Diagnostics International).</p><p><strong>Methods: </strong>Surplus lithium-heparin plasma or serum samples from patients or healthy volunteers were run on Cobas® e 801, e 402, and Pro analyzers. Limits of blank (LoB), limits of detection (LoD), and limits of quantitation (LoQ) were determined according to CLSI EP17-A2, with target values of 1.0 and 1.5 ng/L for LoB/LoD and 3.0 ng/L (10% CV) and 1.5 ng/L (20% CV) for LoQ, respectively. Precision was measured, per CLSI EP17-A2, using 3 QC samples (approximately 4, 30, and 220 ng/L), 12 native samples, and 3 reagent lots. Linearity, per CLSI EP06-Ed2, was determined by diluting samples with cardiac troponin T (cTnT) concentration above the measuring range with a low/blank sample. Interference (per Glick) with endogenous and assay components at 5 cTnT concentrations was assessed.</p><p><strong>Results: </strong>Measured values for LoB, LoD, and LoQ at 10% and 20% CV were 0.1 to 0.7 ng/L, 0.3 to 1.4 ng/L, 1.0 to 2.9 ng/L, and 0.4 to 1.2 ng/L, respectively. Repeatability CVs were 1.0 to 5.8% for mean cTnT concentrations of 2.6 to 9230 ng/L in lithium-heparin plasma. High precision was shown across lots, and linearity was observed across the measuring range (1.5 to 9500 ng/L, all Pearson's r = 1.00). No interferences were observed, specified up to ≤1000 mg/dL hemoglobin, ≤50 mg/dL [≤855 µmol/L] icterus/bilirubin, and ≤1200 ng/mL biotin.</p><p><strong>Conclusions: </strong>The analytical performance characterization of the assay demonstrated high sensitivity, high precision at the low end and across the measuring range, and resistance to interference.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potassium Reference Intervals: A Need for Separate Reference Intervals for Serum and Plasma.","authors":"Glen L Hortin, Joseph Leonard, Claude Bassil","doi":"10.1093/jalm/jfag029","DOIUrl":"https://doi.org/10.1093/jalm/jfag029","url":null,"abstract":"<p><strong>Background: </strong>Accurate potassium measurements are clinically important because life-threatening arrhythmias can occur at high or low potassium levels. Even mild dyskalemia is associated with adverse clinical outcomes. However, preanalytical factors and varying specimen types-serum, plasma, and whole blood-pose challenges in accurately measuring potassium, establishing reference intervals (RIs), and interpreting the results.</p><p><strong>Methods: </strong>Adult RIs for potassium were acquired from 60 laboratory directories. The distribution of plasma potassium values at a cancer center and effects of applying different RIs were evaluated.</p><p><strong>Results: </strong>Surveyed laboratories have 14 different RIs for serum potassium and, usually, the same RI for serum and plasma. Only 4 laboratories had different serum and plasma RIs. Applying common serum RIs to plasma measurements markedly affected the proportions of patient results outside the RI.</p><p><strong>Discussion: </strong>Although potassium measurements are relatively well standardized, laboratory RIs for potassium vary considerably. Most laboratories use the same RI for serum and plasma potassium, although serum and plasma measurements usually differ by 0.2-0.4 mmol/L, exceeding acceptable limits for bias. Consequently, serum-derived RIs are suboptimal RIs for plasma. Testing of plasma specimens is common in acute care settings, but most laboratory RIs and clinical guidelines are based on serum measurements. Outcome studies show that there is a narrow optimal range for potassium levels and that outcomes improve with careful management of potassium levels. Separate RIs and clinical guideline values for plasma and serum potassium offer better assessment of potassium levels.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}