Journal of Applied Laboratory Medicine最新文献

{"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}

{"title":"Temporal Evaluation of the Metabolic Vulnerability Index and Its Components in a Heart Failure Clinical Trial Population.","authors":"Rebeka Rafi, Carolina G Downie, Kayode O Kuku, Alan T Remaley, Joseph J Shearer, Véronique L Roger","doi":"10.1093/jalm/jfag010","DOIUrl":"10.1093/jalm/jfag010","url":null,"abstract":"<p><strong>Background: </strong>Heart failure (HF) is a complex syndrome with high mortality. The Metabolic Vulnerability Index (MVX) is a novel multimarker score derived from inflammation and malnutrition markers that has demonstrated prognostic value in patients with HF; however, changes in MVX over time have not been characterized. The purpose of this study was to evaluate change between baseline and 12-month measurements of the MVX and its components in an HF clinical trial population.</p><p><strong>Methods: </strong>Nuclear magnetic resonance spectroscopy (NMR) MetaboProfile analyses (Labcorp) were performed on paired EDTA baseline and 12-month plasma samples collected from 46 HF patients with preserved ejection fraction (HFpEF) enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT) clinical trial to generate non-sex-specific MVX scores and component analytes. Paired t-tests were used to test the null hypothesis that the differences in paired population means between baseline and 12-months for MVX, or its components, were equal to 0. In sensitivity analyses, we evaluated whether differences in MVX or component values differed by drug status.</p><p><strong>Results: </strong>In this sample, the mean (SD) age was 72.5 (9.2) years; 50% were female, and 89% were White. The prevalence of comorbidities was similar to the full TOPCAT population. MVX mean scores were not significantly different between baseline and 12-month measurements (mean difference = 1.52, 95% CI: -0.97 to 4.01, P = 0.225).</p><p><strong>Conclusions: </strong>MVX scores appeared stable in this cohort over one year. Future studies should evaluate changes in serial measurements of MVX in a larger sample size.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"871-877"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13053036/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146214495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","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":"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":"786-797"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","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}