Journal of Applied Laboratory Medicine最新文献

{"title":"Development, Validation, and Clinical Application of an HPLC-Based Method for Determining Adenosine Deaminase Activity in Adenosine Deaminase Deficiency-Severe Combined Immunodeficiency.","authors":"Maria Petrik, Evgeny Litvin, Andrey Osipyants, Aleksandra Filkova, Yulia Rodina, Dmitrii Blinov, Nikolay Grachev, Anna Shcherbina","doi":"10.1093/jalm/jfag037","DOIUrl":"10.1093/jalm/jfag037","url":null,"abstract":"<p><strong>Background: </strong>Adenosine deaminase (ADA) deficiency is a rare genetic condition leading to severe combined immunodeficiency. Timely and accurate quantification of ADA activity is crucial for both diagnosis and treatment monitoring. This study describes the development and analytical validation of a high-performance liquid chromatography (HPLC)-based method for measuring ADA activity in dried blood spot (DBS) samples.</p><p><strong>Methods: </strong>ADA activity was quantified by measuring the enzymatic conversion of adenosine to inosine and hypoxanthine, followed by chromatographic separation and detection. Method validation was conducted according to current bioanalytical guidelines and included assessment of selectivity, linearity, sensitivity, precision, trueness, extraction recovery, and stability. The study involved 3 groups of samples taken from healthy pediatric donors (n = 116), carriers of pathogenic mutations (n = 13), and patients with genetically confirmed ADA deficiency (n = 11).</p><p><strong>Results: </strong>The assay demonstrated high selectivity and linearity over the tested concentration ranges (coefficient of determination > 0.99 for both analytes). The lower limit of quantification was 0.312 μg/mL (2.29 μmol/L) for hypoxanthine and 0.5 μg/mL (1.86 μmol/L) for inosine. A reference interval for ADA activity in DBS was established at 14.94 to 43.28 nmol/h/mg. The mean ADA activity was 25.06 nmol/h/mg of protein in the control group, 14.08 nmol/h/mg in mutation carriers, and 2.18 nmol/h/mg in patients with ADA deficiency.</p><p><strong>Conclusions: </strong>The developed method allows precise and reliable determination of ADA activity in DBS. It can be applied for the diagnosis and monitoring of patients with ADA deficiency, as well as in scientific studies related to purine metabolism.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"758-769"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729927","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":"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":"798-805"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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":"The Harmonization Hurdle-A Case for Pyridoxal-5'-Phosphate.","authors":"Davor Brinc, Terence A Agbor, Anselmo Fabros, Pow Lee Cheng, Vathany Kulasingam, Rajeevan Selvaratnam","doi":"10.1093/jalm/jfag018","DOIUrl":"10.1093/jalm/jfag018","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"982-985"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147345253","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":"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":"857-862"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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}

{"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":"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":"844-856"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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":"Analytical and Clinical Performance Evaluation of a Novel NT-proBNP Assay with De Novo Antibodies across Different Population Groups.","authors":"Anne Marie Dupuy, Etienne Mondesert, Louis Margueritte, Dana Charif, Marion Morena, Anne Sophie Bargnoux, François Roubille, Jean Paul Cristol","doi":"10.1093/jalm/jfag049","DOIUrl":"10.1093/jalm/jfag049","url":null,"abstract":"<p><strong>Background: </strong>A new N-terminal pro-B-type natriuretic peptide (NT-proBNP) immunoassay using de novo antibodies was developed on a DxI9000© analyzer from Beckman. The aim of this study was to assess its analytical performance, and a comparison with the Elecsys-proBNPII assay from Roche was also performed. NT-proBNP values in healthy adults based on sex and age were established, and clinical performance in the diagnosis of chronic heart failure (CHF), acute heart failure (AHF), aging, and chronic kidney disease (CKD) populations was evaluated.</p><p><strong>Methods: </strong>Analytical performance of the Access NT-proBNP assay was evaluated. A method comparison was performed using 200 fresh plasma samples as well as with all the patient samples included in the study (n = 531). The distribution of Access NT-proBNP levels in healthy subjects, patients with CHF or AHF, and patients with CKD was reported.</p><p><strong>Results: </strong>The total imprecision for NT-proBNP controls was 3.17% and 4.73%, and 3.70% and 10.45% in a plasma pool. The limit of blank and limit of detection were lower than those reported by the manufacturer. Correlation studies showed a good correlation between NT-proBNP measurements using the Access NT-proBNP assay and Roche analyzer.In a healthy population, the NT-proBNP concentrations increased across the age groups and significantly varied in healthy adult men and women throughout the years. In the different pathological situations studied, our results clearly demonstrated that the new NT-proBNP assay from Beckman meets European Society of Cardiology requirements for diagnostic approaches and monitoring of patients suspected of having chronic heart failure.</p><p><strong>Conclusion: </strong>The Access NT-proBNP assay showed acceptable analytical and diagnostic performance in heart failure. In cases of renal failure, our study encourages cautious interpretation of results.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"709-722"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785132","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":"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":"723-734"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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":"10.1093/jalm/jfag045","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"975-976"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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":"Improved Precision of Point-of-Care Analyzers with Automation of Sample Processing.","authors":"Alan H B Wu, Chui Mei Ong, Melissa Alamillo, Ashraf Hanna","doi":"10.1093/jalm/jfag057","DOIUrl":"10.1093/jalm/jfag057","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"990-992"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147989426","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":"Meeting the Operational Needs of Clinical Laboratories around the World.","authors":"Octavia M Peck Palmer, Kamisha L Johnson-Davis, He Sarina Yang, Christina C Pierre","doi":"10.1093/jalm/jfag069","DOIUrl":"10.1093/jalm/jfag069","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"691-695"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147976335","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}