Journal of Applied Laboratory Medicine最新文献_第4页

Analytical and Clinical Performance of a Novel Immunoassay-Based Test System to Predict Diabetic Kidney Disease. 一种基于免疫分析的新型糖尿病肾病检测系统的分析和临床表现。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf097

James K C Lui, Kirsten E Peters, Gareth Fernandez, Isabella A Joubert, Tasha S C Lumbantobing, Timothy M E Davis, Richard J Lipscombe, Scott D Bringans

{"title":"Analytical and Clinical Performance of a Novel Immunoassay-Based Test System to Predict Diabetic Kidney Disease.","authors":"James K C Lui, Kirsten E Peters, Gareth Fernandez, Isabella A Joubert, Tasha S C Lumbantobing, Timothy M E Davis, Richard J Lipscombe, Scott D Bringans","doi":"10.1093/jalm/jfaf097","DOIUrl":"10.1093/jalm/jfaf097","url":null,"abstract":"Background: Diabetes-related chronic kidney disease (DKD) is a leading cause of end-stage kidney disease (ESKD), requiring costly dialysis or kidney transplantation. Existing standard- of-care tests for DKD have several limitations, and an alternative is Promarker®D, a validated plasma biomarker test system that predicts DKD in adults with diabetes up to 4 years before symptoms develop.Methods: To enable high-throughput application of PromarkerD, a novel CaptSureTM immunoassay version of the test was developed targeting plasma biomarkers Apolipoprotein A4 (ApoA4) and CD5 antigen-like (CD5L). The analytical performance of the assay was assessed, and clinical samples from 2 independent clinical cohorts (>1700 adults with type 2 diabetes [T2D]) were used for the development and external validation of the DKD predictive test.Results: The PromarkerD test system combined ApoA4 and CD5L concentrations with clinical factors age and estimated glomerular filtration rate (eGFR) to calculate risk scores (0% to 100%) and classify study participants as either at low, moderate, or high risk for future kidney decline. PromarkerD demonstrated reliable analytical performance and provided a high discriminative capability in adults with T2D (receiver operating characteristic area under the curve [ROC-AUC]: 0.78 to 0.88) to predict 4-year kidney decline, defined as incident DKD (eGFR <60 mL/min/1.73 m2) or eGFR decline ≥40%, with sensitivity of 75.8% to 85.1% at the moderate-risk cutoff and specificity of >92% at the high-risk cutoff across the two cohorts.Conclusion: The next-generation PromarkerD test system offers a convenient yet highly effective tool for DKD risk assessment. By introducing PromarkerD to standard diabetes care, preventative treatment strategies may be implemented early before permanent kidney function loss occurs.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1140-1153"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144691961","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}

引用次数: 0

RhDnostics: A Machine Learning-Based Predictive Algorithm Model for RhD-Negative and DEL Blood Group Screening. rhd诊断：一种基于机器学习的rhd阴性和DEL血型筛选预测算法模型。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf074

Meechoke Choodoung, Charuporn Promwong, Ketsaraporn Wongba, Arunsri Choodoung, Usanee Kerdpin, Peeradech Thichanpiang, Chotiros Plabplueng, Yann Fichou, Pornlada Nuchnoi

{"title":"RhDnostics: A Machine Learning-Based Predictive Algorithm Model for RhD-Negative and DEL Blood Group Screening.","authors":"Meechoke Choodoung, Charuporn Promwong, Ketsaraporn Wongba, Arunsri Choodoung, Usanee Kerdpin, Peeradech Thichanpiang, Chotiros Plabplueng, Yann Fichou, Pornlada Nuchnoi","doi":"10.1093/jalm/jfaf074","DOIUrl":"10.1093/jalm/jfaf074","url":null,"abstract":"Background: The D-elution (DEL) phenotype is serologically mislabeled as Rh-negative because of the very low amount of D antigen on red blood cells. The adsorption-elution test and genotyping are recommended tests for confirmation. However, turnaround time and the availability of instruments, reagents, and budget, as well as technical issues are challenging factors of DEL identification in laboratory practice and patient safety.Methods: To develop a screening predictive algorithm for DEL and Rh-negative, the serological tests of RhCcEe antigen and adsorption-elution tests were computed using a machine learning model.Results: The machine learning algorithm computed the data based on RhCcEe antigen with or without a DEL confirmative serological test like the adsorption-elution test. The predictive accuracy gave >90% for RhD-negative identification in a Thai blood donor dataset. To screen for RhD-negative, we provided the web application named RhDnostics at https://rnp-project-1.streamlit.app/.Conclusion: Our machine learning algorithm could be used as a predictive tool for RhD-negative screening in the laboratory with no confirmative serological test or RHD molecular testing available.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1200-1214"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188228","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}

引用次数: 0

Advances and Skepticism for Broad Implementation of Capillary Collection Devices. 毛细管采集装置广泛应用的进展与质疑。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf100

Dina N Greene, Steven W Cotten, Amy L Pyle-Eilola

引用次数: 0

Prevalence of Hepatitis D in the United States. 美国的丁型肝炎患病率。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf092

Derek L Stark, Seyi Falekun, Shane Jorgensen, Patricia Slev

{"title":"Prevalence of Hepatitis D in the United States.","authors":"Derek L Stark, Seyi Falekun, Shane Jorgensen, Patricia Slev","doi":"10.1093/jalm/jfaf092","DOIUrl":"10.1093/jalm/jfaf092","url":null,"abstract":"Background: Hepatitis D virus (HDV) causes the most severe form of viral hepatitis and exclusively infects people who are also infected with hepatitis B virus (HBV). The global incidence of HDV is estimated to be 5.9%-14.6% of HBV infected individuals, however, the prevalence in the United States is unknown.Methods: In this study, the prevalence of HDV in HBV infected individuals was determined by testing 1104 samples from a national laboratory that were positive for hepatitis B surface antigen with the anti-HDV total antibody ELISA from International Immuno Diagnostics.Results: The prevalence of HDV using the described approach was 1.2% of HBV positive samples. HDV positivity did not correlate with HBV viral load, although the sample size may be insufficient to detect such an effect. HDV RNA, which is present during active infection, was detected in 33% of anti-HDV positive samples.Conclusions: This provides a more reliable estimate for HDV prevalence in the United States that is lower than estimates from previous smaller studies and meta-analyses. A reliable estimate of HDV prevalence is increasingly important due to the advent of several new HDV therapies and the growing consensus among clinicians and professional societies that all HBV infected individuals should also be screened for HDV.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1133-1139"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585191","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}

引用次数: 0

Commentary on Clinical and Molecular Characteristics of Patient with 11-Beta-Hydroxylase Deficiency. 11- β -羟化酶缺乏症患者的临床和分子特征评述。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf049

Sharon Markham Geaghan

引用次数: 0

An Electronic Clinical Surveillance System to Reduce Failure to Follow Up Abnormal Lab Results and Failure to Order Needed Tests: Description and Methods. 一种电子临床监测系统，以减少后续异常实验室结果的失败和未能订购所需的测试：描述和方法。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf073

Michael H Kanter, Wahid Wakach, Royann Timmins, Jasmine E Mitchell, Ariel R Silverman, Tracy M Imley

{"title":"An Electronic Clinical Surveillance System to Reduce Failure to Follow Up Abnormal Lab Results and Failure to Order Needed Tests: Description and Methods.","authors":"Michael H Kanter, Wahid Wakach, Royann Timmins, Jasmine E Mitchell, Ariel R Silverman, Tracy M Imley","doi":"10.1093/jalm/jfaf073","DOIUrl":"10.1093/jalm/jfaf073","url":null,"abstract":"Background: Failure to follow up abnormal test results in a timely manner is a widespread issue in outpatient settings. The etiologies of this problem are multidimensional and vary across settings. While there is currently no widely used intervention to address these issues, multiple studies have noted that there is a need for multifaceted monitoring systems and quality improvement collaboratives to approach this problem.Methods: Kaiser Permanente Southern California (KPSC) implemented a program called SureNet, which addresses the issue of missed laboratory results. KPSC is an integrated healthcare delivery system serving approximately 4.8 million members across 14 hospitals and 200 medical offices. SureNet operates as an electronic clinical surveillance system to detect lapses in care, with a particular focus on ambulatory tests. The functions of SureNet interventions include prompting a specific treatment, a follow-up laboratory test, or a specialist referral.Results: Since its implementation in 2006, SureNet has grown to encompass more than 80 distinct programs, 39 of which focus on missed laboratory tests. The median number of measured interventions in a program was 4971 (range 60-182 249), and the measured percentage of successful interventions was 61% (range 4%-93%). Outcomes demonstrate that SureNet effectively closes care gaps that may have otherwise been missed.Conclusion: KPSC's SureNet represents a potentially generalizable example of an electronic clinical surveillance program that can effectively mitigate the problem of lack of timely follow-up on abnormal laboratory results at scale. SureNet provides a blame-free approach that prioritizes patient care and outcomes.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1362-1375"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192274","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}

引用次数: 0

Commentary on Blue-Green Inclusions in Neutrophils: An Early Indicator of Poor Prognosis? 中性粒细胞蓝绿色包涵体：预后不良的早期指标？

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf099

Sharon M Geaghan

引用次数: 0

Can AI Outperform Human Aspirants? Evaluating 3 ChatGPT Models on the Spanish FIR and BIR Specialized Health Examinations. 人工智能能超越人类吗？3种ChatGPT模型在西班牙FIR和BIR专业健康检查中的评价

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf098

Gonzalo Verdú, Alejandro Calvera Rayo, Aleix B Fabregat-Bolufer

{"title":"Can AI Outperform Human Aspirants? Evaluating 3 ChatGPT Models on the Spanish FIR and BIR Specialized Health Examinations.","authors":"Gonzalo Verdú, Alejandro Calvera Rayo, Aleix B Fabregat-Bolufer","doi":"10.1093/jalm/jfaf098","DOIUrl":"10.1093/jalm/jfaf098","url":null,"abstract":"Background: Artificial intelligence (AI) models are increasingly used in academic and clinical settings that require information synthesis and decision-making. This study explores the performance, accuracy, and reproducibility of 3 OpenAI models-GPT-4o Mini, GPT-4o, and GPT-o1-when applied to the 2023 Spanish FIR (Pharmaceutical Internal Resident) and BIR (Biologist Internal Resident) exams. By assessing their capabilities on these highly specialized tests, we aim to evaluate their potential as reliable tools for academic preparation and clinical support.Methods: Each model was prompted with 200 questions from the 2023 FIR and BIR exams, respectively. The analysis evaluated overall accuracy, official exam scoring, and predicted ranking. Subanalyses focused on multimodal image-based questions and clinical cases. Reproducibility was assessed by retesting all questions from both exams using the Cohen Kappa and McNemar tests.Results: After the first attempt, GPT-o1 achieved the highest accuracy (92% on FIR, 97.0% on BIR), securing top positions in both exams. GPT-4o performed exceptionally (87% on FIR, 97.5% on BIR), surpassing all human candidates on BIR and ranking third on FIR. GPT-4o Mini, while strong (80.5% on FIR, 93.0% on BIR), struggled with complex or image-reliant questions. The reproducibility analysis showed GPT-o1's tendency to correct previous mistakes on retesting, while GPT-4o and GPT-4o Mini more consistently repeated initial answers.Conclusions: These models, particularly GPT-o1, outperformed human examinees, supporting AI integration in exam preparation and clinical training. However, limitations persist in multimodal understanding and specialized subdomains. Human oversight remains essential to ensure reliability in laboratory and clinical practice.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1215-1225"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733855","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}

引用次数: 0

Reference Intervals for Ceruloplasmin Should Account for Age, Sex, Method, and Local Population. 铜蓝蛋白的参考区间应考虑到年龄、性别、方法和当地人口。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf121

Bobby Li, Catherine Rollo, Richard King, Simon Thompson, Chris Florkowski

引用次数: 0

Correcting Potassium Concentrations Measured in Hemolyzed Serum, Plasma, and Whole Blood Samples. 校正溶血血清、血浆和全血样品中测定的钾浓度。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2025-09-03 DOI: 10.1093/jalm/jfaf067

John Toffaletti, Alan H B Wu

{"title":"Correcting Potassium Concentrations Measured in Hemolyzed Serum, Plasma, and Whole Blood Samples.","authors":"John Toffaletti, Alan H B Wu","doi":"10.1093/jalm/jfaf067","DOIUrl":"10.1093/jalm/jfaf067","url":null,"abstract":"Background: Despite clinical laboratories' efforts to instruct proper techniques for sample collection and handling, specimen hemolysis remains a major preanalytical problem, with the highest rates seen from blood of patients drawn from the emergency department and intensive care units. Of all the analytes that are affected by the presence of hemolysis, the interpretation of potassium is the most clinically significant. Equations have been developed to estimate potassium results following measurement of free hemoglobin.Content: We reviewed the need and methodology for correcting serum or plasma concentrations using serum and plasma free hemoglobin levels from published reports. Hemolysis detection is also now available for potassium tests conducted on whole blood samples.Summary: Correcting for hemolysis using equations involving hemoglobin analysis sometimes produces inaccurate results for potassium and may not be appropriate. Qualitative comments such as a sample being \"likely\" abnormal may be acceptable. Reporting a range of corrected potassium results may also be appropriate.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1327-1332"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585190","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}

引用次数: 0