Annals of Laboratory Medicine最新文献

{"title":"Rapid Antifungal Susceptibility Classification of <i>Aspergillus</i> Species Using AI-Assisted Analysis of Routine MALDI-TOF MS Spectra: A Proof-of-Concept Study.","authors":"Hyeyoung Lee, Donggun Seo, Hyun Ji Lee, Hyunjoo Lee, Sung-Il Cho, Jehyun Koo, Kei-Anne Garcia Baritugo, Gi-Ho Sung, Dong-Chan Kim, Jayoung Kim","doi":"10.3343/alm.2026.0069","DOIUrl":"https://doi.org/10.3343/alm.2026.0069","url":null,"abstract":"<p><strong>Background: </strong>The increasing prevalence of antifungal-resistant <i>Aspergillus</i> isolates underscores the need for rapid antifungal susceptibility testing. In this proof-of-concept study, we evaluated whether artificial intelligence (AI) can enable rapid antifungal susceptibility classification of <i>Aspergillus</i> species using routine matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS).</p><p><strong>Methods: </strong>Models were developed using MALDI-TOF MS spectra for 240 isolates (<i>Aspergillus flavus</i> N=126, <i>A. fumigatus</i> N=75, <i>Aspergillus lentulus</i> N=39). Their performance in predicting susceptibility to four antifungal agents (voriconazole, posaconazole, itraconazole, and amphotericin B) was evaluated using a validation set comprising <i>A. flavus</i> (N=24), <i>A. fumigatus</i> (N=24), and <i>A. lentulus</i> (N=22), based on categorical agreement (CA), very major error (VME), major error (ME), sensitivity, and specificity.</p><p><strong>Results: </strong>Although spectrum-level evaluation showed excellent analytical discrimination, isolate-level clinical evaluation demonstrated limited performance across seven species-antifungal agent combinations. Across these combinations, the AI models achieved a mean CA of 56.0%, with VME and ME rates of 53.3% and 45.2%, respectively. Sensitivity ranged from 0% to 100% and specificity from 18.2% to 87.5%, indicating inconsistent susceptibility classification performance across species-antifungal agent combinations.</p><p><strong>Conclusions: </strong>AI-assisted analysis of routine MALDI-TOF MS spectra showed the feasibility of classifying antifungal susceptibility in <i>Aspergillus</i> spp. However, its clinical performance across species-antifungal agent combinations was limited. Further optimization, evaluation with larger multicenter datasets, and external validation are required before considering clinical adoption.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148904971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Laboratory Stewardship: Improving Quality of Care by Linking Clinical Outcomes to Appropriate Test Utilization in Clinical Chemistry Laboratories.","authors":"Kuenyoul Park, Andrew C Don-Wauchope","doi":"10.3343/alm.2026.0193","DOIUrl":"https://doi.org/10.3343/alm.2026.0193","url":null,"abstract":"<p><p>Stewardship of laboratory services aims to ensure appropriate test utilization and improve patient outcomes. However, clinical chemistry initiatives have largely focused on reducing test volumes and costs rather than linking interventions to clinical outcomes. This review examines stewardship strategies for clinical chemistry tests using an outcome-based framework developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM), which classifies outcomes into seven categories: change in patient management, clinical outcomes, economics, operational efficiencies, patient-centeredness, safety, and guide policy making. We review stewardship evidence for three high-impact targets: erythrocyte sedimentation rate/C-reactive protein co-ordering, cardiac troponin with legacy markers, and vitamin D testing. For each target, we summarize the clinical context, intervention strategies, and outcomes mapped to the TF-OSLM framework. Across all three targets, strong evidence supports reductions in test volume and associated cost savings at the institutional and national levels. However, a consistent gap emerges: direct evidence linking these interventions to patient-level clinical outcomes, such as mortality or diagnostic trajectories, remains limited. Safety data remain limited to retrospective observations, and most evidence stems from large academic centers. Public demand for testing, driven by media and wellness culture, poses an additional challenge that can undermine even robust policy interventions. The TF-OSLM framework is readily transferable to other high-volume clinical chemistry tests, and stewardship programs should incorporate prospective evaluation of clinical outcomes alongside utilization metrics to build a comprehensive evidence base for outcome-based quality in laboratory medicine.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148900066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adaptation of the Yield-Scaling Factor to Reduce Target Yield Deviation and Donation Time in Pathogen-Reduced Apheresis Platelet Collections Using the Sysmex XN1000 Blood Bank Mode.","authors":"Marco Amato, Anita Siller, Lisa Seekircher, Manfred Astl, Lena Tschiderer, Peter Willeit, Harald Schennach","doi":"10.3343/alm.2026.0075","DOIUrl":"https://doi.org/10.3343/alm.2026.0075","url":null,"abstract":"<p><strong>Background: </strong>Platelet concentrates from apheresis donations are indispensable in transfusion medicine. Integration of pathogen reduction (PR) technologies into platelet manufacturing requires adjustment of apheresis devices to ensure consistent platelet yields while minimizing donation time. We investigated the suitability of Sysmex XN1000 (Sysmex Corporation, Kobe, Japan) in blood bank mode (BBM) for measuring platelet concentrates to optimize the yield-scaling factor (YSF) of apheresis devices, thereby standardizing target yields and reducing donation time.</p><p><strong>Methods: </strong>We compared measurements with the Sysmex XN530 and XN1000 BBM and evaluated three Trima Accel (Terumo, Tokyo, Japan) YSF setups (YSF 0.90/XN530, YSF 0.90/XN1000, and YSF 1.05/XN1000). Differences in yield deviation and donation time were assessed using linear mixed-effects models adjusted for target yield with robust SEs.</p><p><strong>Results: </strong>We analyzed 4,383 platelet apheresis procedures from 1,573 donors across setups in large-volume (LV) and dual-storage (DS) collections. Compared with YSF 0.90/XN530, YSF 0.90/XN1000 and YSF 1.05/XN1000 significantly reduced yield deviation by 0.26 and 0.41×10¹¹ platelets/unit (95% confidence interval [CI] 0.18-0.34 and 0.35-0.48, respectively) in LV collections and by 0.34 and 0.24×10¹¹ platelets/unit (95% CI 0.24-0.45 and 0.01-0.47, respectively) in DS collections. Compared with YSF 0.90/XN530, YSF 1.05/XN1000 reduced the donation time by 8.09 min (6.93-9.26) and 9.88 min (6.81-12.94) for LV and DS collections, respectively.</p><p><strong>Conclusions: </strong>YSF 0.90/XN1000 and YSF 1.05/XN1000 reduced yield deviation and donation time than did YSF 0.90/XN530, supporting the use of XN1000 BBM to calibrate Trima Accel apheresis devices and can help in standardizing target yields while reducing donation time in PR.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148878929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interference in α-Tocopherol Determination via High-Performance Liquid Chromatography: An Unusual Way to Diagnose an Inborn Error of Metabolism.","authors":"Romain Penicaud, Mylene Gilleron, Anne Frederique Dessein, Dries Dobbelaere, Marie Joncquel","doi":"10.3343/alm.2026.0120","DOIUrl":"https://doi.org/10.3343/alm.2026.0120","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148878949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"When Direct LDL Cholesterol Assays Fail: A Case Series of Analytically Implausible Results.","authors":"Sanghyeun Park, Joonsang Yu, Sollip Kim, Woochang Lee, Sail Chun","doi":"10.3343/alm.2025.0725","DOIUrl":"10.3343/alm.2025.0725","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"633-636"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148041015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance Evaluation of PacBio PureTarget for Multiple Short Tandem Repeat Expansion Detection.","authors":"Eunju Yeom, Yu Jin Park, Saeam Shin, Seung-Tae Lee, Mi-Kyeong Lee, Kyoung-Ryul Lee, Dongju Won, Jong Rak Choi","doi":"10.3343/alm.2025.0414","DOIUrl":"10.3343/alm.2025.0414","url":null,"abstract":"<p><strong>Background: </strong>Excessive repeat sequence expansion in the human genome causes neurodegenerative diseases. Conventional tandem repeat expansion detection methods often fail to amplify GC-rich repeat regions and cannot help in simultaneously detecting multiple regions. To overcome those limitations, we tested the PacBio PureTarget repeat expansion panel, a new target enrichment test without PCR amplification, and compared its performance with that of conventional repeat expansion detection methods, using clinical and reference samples.</p><p><strong>Methods: </strong>We used the PacBio PureTarget repeat expansion panel, which targets 20 genes with clinically relevant repeat regions, to assess eight samples from the Coriell Institute for Medical Research (Camden) and six patient samples (previously tested for <i>FMR1</i> repeat expansions via repeat-primed [RP] PCR). Data were analyzed using the tandem repeat genotyping tool.</p><p><strong>Results: </strong>For all samples tested, the long-read sequencing results showed 100% concordance with the RP-PCR or Southern blotting results. Discrepancies in repeat counts were observed in a few alleles, with a maximum difference of 157 motifs in <i>DMPK</i>. The method successfully quantified long repeats in <i>FMR1</i>, demonstrating its applicability.</p><p><strong>Conclusions: </strong>The PacBio PureTarget repeat expansion panel, which uses targeted enrichment based on clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 and long-read sequencing, is a promising approach for repeat expansion detection, overcoming the limitations of conventional methods. This approach enabled parallel analysis of multiple candidate genes implicated in neurodegenerative diseases with overlapping clinical features, supporting its potential integration into future clinical diagnostic workflows.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"595-602"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146163926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Length Matters: Toward the Clinical Adoption of Long-Read Sequencing.","authors":"Young-Gon Kim, Hee-Jin Kim","doi":"10.3343/alm.2026.0466","DOIUrl":"10.3343/alm.2026.0466","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"501-503"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148668275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating Sustainability into ISO 15189.","authors":"Mark Lum","doi":"10.3343/alm.2025.0743","DOIUrl":"10.3343/alm.2025.0743","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"524-527"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147760895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of a High-Resolution HPLC System to Quantify HbE for α⁰-Thalassemia Diagnosis in HbE Heterozygotes.","authors":"Wibhasiri Srisuwan, Surada Satthakarn, Sitthichai Panyasai","doi":"10.3343/alm.2025.0552","DOIUrl":"10.3343/alm.2025.0552","url":null,"abstract":"<p><strong>Background: </strong>HbE and α⁰-thalassemia are highly prevalent in Southeast Asia and co-inherited in asymptomatic carriers. α⁰-Thalassemia screening in HbE heterozygotes relies on HbE quantification. We evaluated the performance of a high-resolution HPLC system in quantifying HbE and HbA₂ to distinguish HbE heterozygotes with and without α⁰-thalassemia.</p><p><strong>Methods: </strong>HbE heterozygotes (N=650) presenting EA patterns on capillary electrophoresis (CE) were analyzed using the Premier Resolution (PR) HPLC system (Trinity Biotech). HbA₂ and HbE levels were quantified, Pearson correlations with CE assessed, and diagnostic cutoffs determined. A prospective cohort of HbE heterozygotes (N=884) was used for validation. α⁰-Thalassemia genotyping was performed using gap-PCR.</p><p><strong>Results: </strong>PR-HPLC confirmed HbE heterozygosity and successfully separated HbA₂ from HbE. The HbA₂, HbE, and combined HbA₂+HbE levels were consistently higher than but correlated with CE values (HbA₂: bias=1.213, r=0.686; HbE: bias=0.286, r=0.960; combined: bias=1.502, r=0.952). HbE and combined levels were substantially lower in α⁰-thalassemia carriers (14.65%±2.2% vs. 19.38%±2.5%); HbA₂ levels did not significantly differ. HbE cutoff <19% resulted in an area under the curve (AUC) of 0.975, with 100% sensitivity and 91.9% specificity. HbE+HbA₂ <24.0% yielded an AUC of 0.970, with 100% sensitivity and 89.7% specificity. Validation experiments supported the robust performance for HbE detection alone (100% sensitivity, 93.6% specificity, and 94.5% accuracy).</p><p><strong>Conclusions: </strong>PR-HPLC can quantify HbE precisely, potentially aiding in robust α⁰-thalassemia diagnosis and screening without HbA₂ assessment.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"528-538"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458170/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146163938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to Letter to the Editor on \"Clinical Characteristics and Mortality Risk Factors of <i>Candida lusitaniae</i> Candidemia: A Multicenter Study in Korea\".","authors":"Eun Jeong Won","doi":"10.3343/alm.2026.0089","DOIUrl":"10.3343/alm.2026.0089","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"645-646"},"PeriodicalIF":4.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458165/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147760938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}