Journal of Applied Laboratory Medicine最新文献

{"title":"Outside the Laboratory-A New Section in JALM.","authors":"Ian S Young","doi":"10.1093/jalm/jfag036","DOIUrl":"https://doi.org/10.1093/jalm/jfag036","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 3","pages":"679"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844218","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":"Health Literacy/Numeracy-Related Factors Affecting Interpretation of Medical Laboratory Values.","authors":"Rachel L Childs","doi":"10.1093/jalm/jfaf192","DOIUrl":"10.1093/jalm/jfaf192","url":null,"abstract":"<p><strong>Background: </strong>Health literacy and numeracy are broad terms that relate to a patient's understanding of their health information. While there is a substantial amount of research on this topic in a general sense as well as in relation to how deficiencies in these skills impact patients' understanding of laboratory results, little is known regarding the extent to which underlying factors, which are impacted by health literacy/numeracy, affect how patients interpret their results. This literature review attempts to shed light on the current literature on this more focused and narrow issue, including recommendations to address these barriers.</p><p><strong>Content: </strong>To perform this review, the key terms \"health literacy AND numeracy,\" \"health literacy AND laboratory results,\" and \"patient understanding of laboratory test results\" were searched in the PubMed Central, Health Source: Nursing/Academic Edition, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. After reviewing articles for inclusion and exclusion criteria, a total of 16 articles were included. Major themes from the articles utilized were (a) the impact of the laboratory, (b) factors that affect health literacy and numeracy of laboratory data, and (c) recommendations to improve patient understanding and comprehension of their test results.</p><p><strong>Summary: </strong>Many factors affect patients' comprehension of laboratory data, such as access to this information, data presentation, and holistic influences. Recommendations for improving patient health numeracy of laboratory information are to improve how data is presented to patients and to increase access to supplemental resources via patient portals.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"620-631"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145946629","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":"Hemolysis, Icterus, and Lipemia Interference Limits for Serum β-hydroxybutyrate Testing.","authors":"Mark A Cervinski, Macey J Smith, Gracie Forgues, Lynn A Brunelle","doi":"10.1093/jalm/jfag001","DOIUrl":"10.1093/jalm/jfag001","url":null,"abstract":"<p><strong>Background: </strong>Measurement of β-hydroxybutyrate (BOHB) is a valuable tool for the assessment of metabolic acidoses. In this study we evaluated hemolysis, icterus, and lipemia interference thresholds for a commonly used BOHB assay, the Stanbio β-Hydroxybutyrate LiquiColor reagent, on 3 different Roche cobas analyzers.</p><p><strong>Methods: </strong>Remnant patient samples were combined to generate pools with target BOHB concentrations of approximately 0.20, 3.00, and 7.00 mmol/L into which increasing amounts of hemolysate, bilirubin, or Intralipid® were added. Samples were measured in triplicate for both interferences and BOHB concentration on Roche cobas c502, c501, and c311 analyzers.</p><p><strong>Results: </strong>We determined that the Stanbio β-Hydroxybutyrate LiquiColor reagent will tolerate hemolysis to a hemolysis index of 400 (approximately 400 mg/dL hemoglobin) for BOHB concentrations ≤1.00 mmol/L, or 1010 for BOHB concentrations of >1.00 mmol/L. For icterus, the assay was unaffected by bilirubin to an icterus index of 25 [approximately 25 mg/dL bilirubin (427 μmol/L)] for all concentrations tested. Using the most conservative data from our study, the lipemia index limit was set at 800.</p><p><strong>Conclusions: </strong>Our studies across 3 laboratories running 3 different cobas modules allowed our health system to better define permissible limits of sample quality and these updated values will reduce the number of unnecessary cancelations as compared to the limits defined by the manufacturer. Our data also demonstrated heterogeneity of interference between analyzer models, which is an important consideration for those seeking to adopt the limits determined on analyzers other than those in their own laboratories.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"493-503"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146120452","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":"https://doi.org/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":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-29","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":"Application of Six Sigma, Quality Goal Index, Method Decision Chart, and Operating Specification Metrics as Stringent Quality Control Tools for Assessing the Analytical Performance of BUN, Creatinine, and Glucose in an ISO 15189:2022-Accredited Laboratory.","authors":"Maisoon Amarni, Kamal Dumaidi, Sara Abbadi, Nataly Fakhouri, Amer Al-Jawabreh","doi":"10.1093/jalm/jfag043","DOIUrl":"https://doi.org/10.1093/jalm/jfag043","url":null,"abstract":"<p><strong>Background: </strong>Reliable analytical performance is vital for accurate diagnosis in clinical chemistry laboratories. Quality control (QC) strategies must be customized to assess performance, meet regulatory standards, and optimize resource use. This study evaluated the analytical performance of 3 routine analytes, blood-urea nitrogen (BUN), creatinine, and glucose using Sigma metrics, visualized through the Method Decision Chart (MDC), Quality Goal Index (QGI), and Operating Specifications (OPSpecs) charts, to recommend appropriate internal quality control (IQC) procedures at 3 levels (L1, L2, L3).</p><p><strong>Methods: </strong>A 6-month retrospective analysis (June-November 2024) was performed in an ISO 15189:2022 accredited primary health care laboratory in Jenin District, Palestine. Internal QC and External Quality Assessment Scheme data were used to calculate the coefficient of variation (%CV), %bias, and Sigma values across all IQC levels, applying CLIA total allowable error limits. For analytes with Sigma <4, QGI ratios differentiated between imprecision, inaccuracy, or combined error sources. MDC and OPSpecs charts guided the selection of Westgard QC rules.</p><p><strong>Results: </strong>Glucose demonstrated excellent performance (σ > 6), allowing a simplified IQC protocol (1-3.5s, N3, R1). Creatinine showed moderate performance (σ = 3.1-13.6) requiring multirule application (2 of 3-2s, R4s) at Level 2. BUN displayed poor Sigma values (σ < 4), with QGI analysis indicating alternating imprecision and inaccuracy; OPSpecs recommended full multirule implementation and root-cause investigation.</p><p><strong>Conclusion: </strong>The combined use of Sigma metrics, QGI, MDC, and OPSpecs charts offers an effective, risk-based QC framework enabling early detection, continuous monitoring, and timely correction of analytical errors in ISO 15189-certified laboratories.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785074","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":"Benefits and Costs of Multi-Cancer Early Detection.","authors":"Miyo K Chatanaka, Eleftherios P Diamandis","doi":"10.1093/jalm/jfag053","DOIUrl":"https://doi.org/10.1093/jalm/jfag053","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785077","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":"High-Sensitivity Cardiac Troponin I and Clinical Outcomes of Major Acute Cardiac Events.","authors":"Michelle N Steiner, Niti B Vyas, Juan U Rojo, Muneeza Esani","doi":"10.1093/jalm/jfag035","DOIUrl":"https://doi.org/10.1093/jalm/jfag035","url":null,"abstract":"<p><strong>Background: </strong>The long-term benefit of sex-specific 99th percentile upper reference limits (URLs) in conjunction with high-sensitivity cardiac troponin assays for suspected acute coronary syndrome (ACS) are emerging. We evaluated the long-term outcomes of patients reclassified by this approach using the Beckman Coulter Access high-sensitivity troponin I (hs-cTnI) assay.</p><p><strong>Methods: </strong>A retrospective observational study evaluated 1486 emergency department (ED) patients with hs-cTnI results for 3 years and 80 days. Patients whose values exceeded the sex-specific URL but remained below the conventional URL were identified and compared with non-reclassified controls.</p><p><strong>Results: </strong>Reclassification occurred 30% more frequently in women (7.6%, 68/893) compared to men (5.7%, 34/593) and demonstrated higher rates of major adverse cardiac events (MACEs), coronary artery disease, and cerebrovascular disease. Among reclassified men, myocardial infarction (MI) was more often followed by death. Among women, reclassification was associated with MI or death, but rarely both. Time to first post-ED MACE was significantly longer in reclassified patients. In a Cox regression model, reclassification independently predicted a 52.5% lower hazard of MACE over time (P = 0.016). The regression model also described Class 1 obesity as protective, with a 68.2% hazard reduction vs normal weight (P < 0.001).</p><p><strong>Conclusions: </strong>Integration of sex-specific URLs and a hs-cTnI assay identified patients at increased cardiovascular risk, yet was associated with improved long-term outcomes, suggesting potential clinical value. Findings also reinforce the obesity paradox, with Class 1 obesity linked to reduced MACE risk.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785139","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":"Correlates of Serum Concentrations of Biomarkers Relevant to Ovarian Cancer Screening.","authors":"Maxwell Akonde, Whitney Spannuth Graybill, Alyssa Clay-Gilmour, Jiajia Zhang, Anthony J Alberg","doi":"10.1093/jalm/jfag044","DOIUrl":"https://doi.org/10.1093/jalm/jfag044","url":null,"abstract":"<p><strong>Background: </strong>Many biomarkers have been evaluated as potential early detection markers for ovarian cancer. Better understanding of factors associated with inter-individual variation in circulating concentrations of these biomarkers is useful for optimizing their clinical utility for early detection. The study objective was to characterize the associations of sociodemographic-, lifestyle-, and health-related factors in relation to circulating ovarian biomarker concentrations in cancer-free women.</p><p><strong>Methods: </strong>The associations between the independent variables and concentrations of 20 biomarkers were examined in a cross-sectional study of 913 women without ovarian cancer who participated in the ovarian cancer screening arm of the Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial.</p><p><strong>Results: </strong>Older age was significantly associated with trends in concentrations of ten biomarkers, eight that increased with age (human epididymis protein 4 [HE4], beta-2-microglobulin [B2M], epidermal growth factor receptor [EGFR], insulin-like growth factor binding protein 2 [IGFBPII], kallikrein-related peptidase [KLK6], mesothelin [MSLN], matrix metalloproteinase-3 [MMP3], and spondin 2 [SPON2]) and two that decreased with age (insulin-like growth factor 2 [IGFII] and inter-alpha-trypsin inhibitor heavy chain H4 [ITIH4]). Compared to women with no family history of breast or ovarian cancer, those with a positive family history had significantly higher concentrations of B2M, EGFR, and hepcidin and lower concentrations of cancer antigen 125 (CA125) and cancer antigen 72.4 (CA72.4). Post hoc case-control comparisons showed case-control heterogeneity concentrated in specific biomarkers; for example, case-control differences for cancer antigen 15.3 (CA15.3) were statistically significant for all 11 independent variables.</p><p><strong>Conclusion: </strong>Significant trends were observed between age and circulating concentrations of 10 of the 20 biomarkers studied. The strong, consistent findings with age support the need to consider age when assigning thresholds for biomarkers being evaluated for the early detection of ovarian cancer. Integrating data from cancer cases provides valuable context for assessing the generalizability of findings.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785056","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":"Laboratory Medicine Approaches for Assessing Delayed Graft Function in Renal Transplant.","authors":"Tiffany K Bratton, Annalara G Fischer, Christopher T Burns, Roland Valdes","doi":"10.1093/jalm/jfag048","DOIUrl":"https://doi.org/10.1093/jalm/jfag048","url":null,"abstract":"<p><strong>Background: </strong>Delayed graft function (DGF) remains a significant complication in renal transplantation, adversely affecting graft survival, patient quality of life, and healthcare costs. As kidney transplantation rates rise in the United States, there is increasing emphasis on optimizing donor organ selection and improving posttransplant outcomes. A key challenge lies in the early identification and prediction of graft dysfunction to guide timely interventions.</p><p><strong>Content: </strong>This review examines the multifactorial causes, risk factors, and consequences of DGF, including ischemia-reperfusion injury and both recipient and donor determinants. It highlights emerging biomarkers, such as neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, proenkephalin, and interleukin-18, that hold promise for early detection and risk stratification. The integration of artificial intelligence into predictive modeling is explored as a means to combine molecular, clinical, and procedural variables into comprehensive tools for improving organ allocation and individualized management.</p><p><strong>Summary: </strong>Expanding biomarker assessment to the donor preoperative phase may yield earlier and more holistic insights into organ quality. Standardization in biomarker measurement and greater focus on donor characterization are essential to strengthen predictive reliability and clinical translation.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785108","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":"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":"https://doi.org/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":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-21","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}