Journal of Applied Laboratory Medicine最新文献_第6页

In Reply to The Environmental Impact of Inappropriate Clinical Laboratory Testing: What's New? 回应不适当的临床实验室检测对环境的影响：有什么新进展？

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-23 DOI: 10.1093/jalm/jfaf051

Emilie Catry, Giuseppe Lippi, Pauline Modrie, Solemne Durand, Luigi Devis, Jonathan Degosserie, François Mullier, Mélanie Closset

引用次数: 0

The Environmental Impact of Inappropriate Clinical Laboratory Testing: What's New? 不适当的临床实验室检测对环境的影响：有什么新发现？

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-23 DOI: 10.1093/jalm/jfaf050

Luigi Valdenassi, Geir Bjørklund, Umberto Tirelli, Salvatore Chirumbolo

引用次数: 0

Commentary on Uric-a! Hyperuricemia in the Setting of Extreme Leukocytosis. Uric-a！极端白细胞增多症的高尿酸血症。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-23 DOI: 10.1093/jalm/jfaf054

Erica M Fatica

引用次数: 0

Uric-a! Hyperuricemia in the Setting of Extreme Leukocytosis. Uric-a !极端白细胞增多症的高尿酸血症。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-23 DOI: 10.1093/jalm/jfae166

Danielle K Stamer, Samuel Dos Reis Freire, David J Kemble

引用次数: 0

A Gradual Positive Bias in Chloride Measurements with a Major Automated Chemistry Platform. 氯离子测量中的逐渐正偏置与主要自动化化学平台。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-22 DOI: 10.1093/jalm/jfaf046

Kwaku Twum, Nichole Korpi-Steiner, Ruhan Wei, Steven W Cotten

{"title":"A Gradual Positive Bias in Chloride Measurements with a Major Automated Chemistry Platform.","authors":"Kwaku Twum, Nichole Korpi-Steiner, Ruhan Wei, Steven W Cotten","doi":"10.1093/jalm/jfaf046","DOIUrl":"https://doi.org/10.1093/jalm/jfaf046","url":null,"abstract":"Background: Chloride is an extracellular anion commonly measured using ion-selective electrode methods standardized to traceable reference materials. This study investigates the gradual appearance of a positive bias in chloride measurements using the Siemens Healthineers Atellica CH platform that was undetectable via routine quality control or proficiency testing.Methods: The bias was characterized using retrospective analysis of laboratory values from presumable healthy outpatients (ICD-10 code Z00.00), reference interval verifications, peer group means from the College of American Pathologists' proficiency testing C survey, and a method comparison study with an alternate platform.Results: Retrospective analysis of patient data (2017-2024) revealed a gradual shift in median patient chloride concentrations distinct from stable trends observed for other electrolytes. In 2024, reference interval verification revealed that 64.3% of chloride results were above the reference interval, even though the verification was successful in 2021. Proficiency testing results were acceptable compared to peer method; however, revealed a mean positive bias of 3.19 mmol/L when compared to other indirect ISE methods (2019-2024). A method comparison with an alternate chemistry platform demonstrated a mean bias of +4.3 mmol/L using remnant patient samples.Conclusions: The use of peer targets for quality control and proficiency testing concealed the detection of a gradual drift in chloride measurements in our laboratory. Analysis of aggregate patient data using ICD-10 codes represents a powerful tool for laboratories when assay performance is questioned. These findings highlight the need for vigilant monitoring of assay drift even for routine analytes to avert potential impact on patient care.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987320","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

Variants of Unknown Significance in Hyperlipidemia: A Diagnostic Quandary. 高脂血症中意义未知的变异：一个诊断难题。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-22 DOI: 10.1093/jalm/jfaf027

Gary Roulston, Pádraig Hart, Paul K Hamilton

引用次数: 0

Commentary on Variants of Unknown Significance in Hyperlipidemia: A Diagnostic Quandary. 对高脂血症中意义未知的变异的评论：一个诊断难题。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-22 DOI: 10.1093/jalm/jfaf055

Rafael Zubiran, Marcelo Amar, Alan T Remaley

引用次数: 0

Point-of-Care Testing Glucometer in Rapid Assessment Settings: Comparison of 2 Network-Capable Devices in a Referral Hospital. 快速评估设置中的即时检测血糖仪：转诊医院2种网络设备的比较

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-18 DOI: 10.1093/jalm/jfaf048

Giacomo Moretti, Giorgia Degni, Camilla Lamiano, Eugenia Tulli, Andrea Urbani

{"title":"Point-of-Care Testing Glucometer in Rapid Assessment Settings: Comparison of 2 Network-Capable Devices in a Referral Hospital.","authors":"Giacomo Moretti, Giorgia Degni, Camilla Lamiano, Eugenia Tulli, Andrea Urbani","doi":"10.1093/jalm/jfaf048","DOIUrl":"https://doi.org/10.1093/jalm/jfaf048","url":null,"abstract":"Background: Point-of-care testing (POCT) glucose meters are essential for rapid glucose monitoring. This study aimed to evaluate the analytical performance of 2 novel network-capable POCT glucometers, CobasPulse (Roche Diagnostic) and StatStrip (Nova Biomedical), in comparison to the Atellica CH 930 Analyzer (Siemens Healthcare), a central laboratory clinical chemistry analyzer, as a reference method.Methods: A cohort of 150 patients' venous whole blood samples were analyzed. Method comparison was performed using Passing-Bablok regression and Bland-Altman plots. Precision studies were conducted using commercial controls, with assessment of within-run and between-run imprecision by experienced laboratory technicians. Performance was assessed against FDA 2020 benchmarks.Results: Passing-Bablok regression showed accurate overlap for both POCT devices. CobasPulse exhibited a bias of -0.17 mmol/L and Pearson r of 0.982, while StatStrip showed a bias of -0.35 mmol/L and Pearson r of 0.959. Within-run CV for Cobas Pulse (3.3 mmol/L control) was 2.4%, and for StatStrip (3.44 mmol/L control) was 5.2%. Between-run CVs were 2.1% for Cobas Pulse and 3.2% for StatStrip at comparable glucose concentrations.Conclusions: Both CobasPulse and StatStrip demonstrated acceptable concordance with the Atellica CH 930 Analyzer. While Cobas Pulse showed slightly better agreement and precision, both devices are suitable for glucose measurements in healthcare settings, providing reliable results and reduced turnaround time, supporting timely clinical decisions for rapid glycemic assessment.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056017","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

Evaluation of the Analytical Sensitivity of a Molecular Point-of-Care Assay as Compared to 3 Lateral Flow Assays for Group A Streptococcus. a群链球菌的分子即时检测与3种横向流动检测的分析敏感性评价

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-18 DOI: 10.1093/jalm/jfaf042

Alamelu Chandrasekaran, Abdullah Kilic, Rinki Kumar, Daniel A Green, Fann Wu, Gregory J Berry

{"title":"Evaluation of the Analytical Sensitivity of a Molecular Point-of-Care Assay as Compared to 3 Lateral Flow Assays for Group A Streptococcus.","authors":"Alamelu Chandrasekaran, Abdullah Kilic, Rinki Kumar, Daniel A Green, Fann Wu, Gregory J Berry","doi":"10.1093/jalm/jfaf042","DOIUrl":"https://doi.org/10.1093/jalm/jfaf042","url":null,"abstract":"Background: An accurate and timely diagnosis of pharyngitis caused by group A streptococcus (GAS) is essential for ensuring appropriate antibiotic therapy. Early detection through point-of-care (POC) testing is valuable in initiating effective treatment. This study aimed at evaluating the analytical sensitivity of the molecular ID NOW™ Strep A 2 POC test as compared to 3 POC lateral flow assays: BD Veritor™ Plus System, Sofia® Strep A+ Fluorescent Immunoassay, and Sekisui Diagnostic OSOM® Strep A test for GAS detection.Methods: Two Streptococcus pyogenes bacterial American Type Culture Collection (ATCC) isolates and one clinical isolate from a throat swab sample were used to evaluate the limit of detection (LoD) of each assay. Ten-fold serial dilutions of the isolates starting from 107 colony factor units (CFU)/mL were prepared, and each dilution was tested in triplicate for all 4 assays simultaneously. All tests were performed as per manufacturers' instructions. The LoD was defined as the last dilution that yielded positive results for all 3 replicates. CFU per swab was also calculated.Results: For the 3 isolates evaluated, LoDs of ID NOW Strep A 2 ranged from 3.125 × 103 to 2.5 × 104 CFU/mL; for Quidel Sofia the range was 1 × 106 to 1 × 107 CFU/mL; for BD Veritor the range was 1 × 107 to 1.5 × 107 CFU/mL; and for Sekisui OSOM the LoD was 1 × 107 CFU/mL for all 3 isolates.Conclusions: Compared to antigen-based lateral flow assays (LFAs), the molecular ID Now Strep A 2 assay demonstrated a lower LoD, which translates into higher sensitivity. In a clinical setting, this could enable detection of samples with a lower bacterial load that could be missed by low-sensitivity LFAs.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144044330","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

Large Language Models Lack Sufficient Performance to Provide Definitive Regulatory Guidance. 大型语言模型缺乏足够的性能来提供明确的监管指导。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2025-04-18 DOI: 10.1093/jalm/jfaf047

Ryan C Shean, Jonathan R Genzen, Nicholas C Spies

引用次数: 0