Chun Kiat Lee, Janet Weng Sze Cheng, Nur Atiqah Liyana, Dilys Shi Ning Lau, Kelvin Kyaw Lin, Tim Hon Man Chan, Ka Lip Chew, Jeanette Woon Pei Teo
Background: Multidrug-resistant yeast Candida (Candidozyma) auris, responsible for healthcare-associated outbreaks and high mortality, is a major global health threat. Rapid and scalable molecular diagnostics is essential; however, few automated platforms can accommodate both commercial assays and laboratory-developed tests (LDTs). We evaluated the analytical and clinical performance of two real-time PCR assays for C. auris detection using the AltoStar Automation System AM16.
Methods: One assay was an in-house LDT (targeting the internal transcribed spacer region), while the other was AltoStar C. auris PCR Kit 1.5 (Altona Diagnostics) assay. An integrated workflow, which included automated nucleic acid extraction and PCR setup, was employed. Analytical performance was evaluated in terms of precision, specificity, and limit of detection (LoD) using C. auris Clades I, II, and VI. Clinical accuracy was assessed using a 36-sample panel (surveillance swabs and contrived positives) tested in parallel with the DiaSorin Simplexa C. auris Direct assay (DiaSorin Molecular LLC), with culture as the reference standard.
Results: Both assays demonstrated excellent reproducibility, with CVs below 5%, and 100% analytical specificity. The in-house LDT showed greater sensitivity, with LoDs of 25-191 colony-forming units (CFU)/mL (1.56-12 CFU/reaction) versus 52-235 CFU/mL (3.25-15 CFU/reaction) for the Altona assay. Regarding clinical accuracy, the LDT, Altona assay, and DiaSorin assay showed 100% positive and negative agreement with the culture results (Cohen's kappa=1.00).
Conclusions: This is the first documented comparison of a commercial assay and an LDT on the AltoStar AM16, demonstrating the platform's flexibility, which can enhance laboratory adaptability and capacity to combat the spread of C. auris, a critical fungal pathogen.
背景：多药耐药酵母念珠菌（念珠菌）耳是造成卫生保健相关暴发和高死亡率的主要原因，是一个主要的全球健康威胁。快速和可扩展的分子诊断是必不可少的；然而，很少有自动化平台可以同时容纳商业分析和实验室开发的测试（LDTs）。我们使用AltoStar自动化系统AM16评估了两种实时PCR检测auris的分析和临床性能。方法：一种是内部LDT（针对内部转录间隔区），另一种是AltoStar C. auris PCR Kit 1.5 （Altona Diagnostics）检测。采用了一个集成的工作流程，包括自动核酸提取和PCR设置。使用C. auris Clades I、II和VI对分析性能进行了精密度、特异性和检出限（LoD）方面的评估。使用36个样本（监测拭子和人为阳性）与DiaSorin Simplexa C. auris Direct assay （DiaSorin Molecular LLC）平行测试，以培养为参考标准，评估临床准确性。结果：两种方法均具有良好的重现性，CVs低于5%，分析特异性为100%。内部LDT显示出更高的灵敏度，LoDs为25-191菌落形成单位(CFU)/mL （1.56-12 CFU/反应），而Altona法的LoDs为52-235 CFU/mL （3.25-15 CFU/反应）。关于临床准确性，LDT、Altona试验和DiaSorin试验与培养结果100%阳性和阴性一致（Cohen’s kappa=1.00）。结论：这是首次在AltoStar AM16上对商业检测和LDT进行比较，证明了该平台的灵活性，可以增强实验室的适应性和对抗C. auris（一种关键真菌病原体）传播的能力。
{"title":"Evaluating a Flexible Workflow for <i>Candida auris</i> Surveillance on the AltoStar Automation System AM16 with Commercial and In-House Real-Time PCR Assays.","authors":"Chun Kiat Lee, Janet Weng Sze Cheng, Nur Atiqah Liyana, Dilys Shi Ning Lau, Kelvin Kyaw Lin, Tim Hon Man Chan, Ka Lip Chew, Jeanette Woon Pei Teo","doi":"10.3343/alm.2025.0574","DOIUrl":"10.3343/alm.2025.0574","url":null,"abstract":"<p><strong>Background: </strong>Multidrug-resistant yeast <i>Candida</i> (<i>Candidozyma</i>) <i>auris</i>, responsible for healthcare-associated outbreaks and high mortality, is a major global health threat. Rapid and scalable molecular diagnostics is essential; however, few automated platforms can accommodate both commercial assays and laboratory-developed tests (LDTs). We evaluated the analytical and clinical performance of two real-time PCR assays for C. auris detection using the AltoStar Automation System AM16.</p><p><strong>Methods: </strong>One assay was an in-house LDT (targeting the internal transcribed spacer region), while the other was AltoStar <i>C. auris</i> PCR Kit 1.5 (Altona Diagnostics) assay. An integrated workflow, which included automated nucleic acid extraction and PCR setup, was employed. Analytical performance was evaluated in terms of precision, specificity, and limit of detection (LoD) using <i>C. auris</i> Clades I, II, and VI. Clinical accuracy was assessed using a 36-sample panel (surveillance swabs and contrived positives) tested in parallel with the DiaSorin Simplexa <i>C. auris</i> Direct assay (DiaSorin Molecular LLC), with culture as the reference standard.</p><p><strong>Results: </strong>Both assays demonstrated excellent reproducibility, with CVs below 5%, and 100% analytical specificity. The in-house LDT showed greater sensitivity, with LoDs of 25-191 colony-forming units (CFU)/mL (1.56-12 CFU/reaction) versus 52-235 CFU/mL (3.25-15 CFU/reaction) for the Altona assay. Regarding clinical accuracy, the LDT, Altona assay, and DiaSorin assay showed 100% positive and negative agreement with the culture results (Cohen's kappa=1.00).</p><p><strong>Conclusions: </strong>This is the first documented comparison of a commercial assay and an LDT on the AltoStar AM16, demonstrating the platform's flexibility, which can enhance laboratory adaptability and capacity to combat the spread of <i>C. auris</i>, a critical fungal pathogen.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148934","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":"Necessity for Development and Validation of Comprehensive Circulating Tumor DNA Profiling Panels.","authors":"Young-Gon Kim,Jong-Won Kim","doi":"10.3343/alm.2026.0023","DOIUrl":"https://doi.org/10.3343/alm.2026.0023","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"72 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069867","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":"A Novel Algorithm for Detecting Monoclonal IgM in Patients with an Elevated Lipemia Index Using the Beckman Coulter AU5800 Analyzer.","authors":"Álvaro Piedra-Aguilera,Carla Fernández-Prendes,Susana Malumbres-Serrano,Laura Abril-Sabater,Albert Oriol-Rocafiguera,Cristian Morales-Indiano","doi":"10.3343/alm.2025.0456","DOIUrl":"https://doi.org/10.3343/alm.2025.0456","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"130 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069842","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}
Heejeong Kwon,Jeoungyeon Kim,Jinnam Kim,Se Yoon Park,Choseok Yoon,Yangsoon Lee,Bongyoung Kim
The extended-spectrum β-lactamase (ESBL) CTX-M-55, a CTX-M-15 variant distinguished by an amino-acid substitution (Ala77Val), has enhanced enzymatic activity due to higher structural stability. In Korea, CTX-M-55 remains insufficiently characterized, particularly in the context of urinary tract infections (UTIs). We identified CTX-M-55 among uropathogenic Escherichia coli isolates and compared its microbiological characteristics with those of CTX-M-15. In total, 247 E. coli isolates were collected from patients with acute pyelonephritis at Hanyang University Seoul Hospital, an 860-bed tertiary-care hospital, between July 2019 and December 2021. ESBL production was confirmed using a double-disk synergy test, and minimum inhibitory concentrations (MICs) were determined. Resistance genes were detected using PCR, and CTX-M-15 sequences were analyzed. Among 38 isolates detected using PCR, eight were confirmed as CTX-M-55 using further sequence analysis. CTX-M-55 showed (P >0.05) a trend toward increased resistance to aztreonam, cefotaxime, ceftazidime, and cefepime, while showing decreased resistance to amoxicillin/clavulanate and piperacillin/tazobactam. CTX-M-55 had higher MIC50 values than CTX-M-15 for ceftazidime (>16 vs. 8 μg/mL), cefepime (32 vs. 1 μg/mL), and piperacillin/tazobactam (0.5 vs. 0.25 μg/mL). Virulence factors and coexisting resistance genes did not significantly differ. Our findings suggest that, given its increased resistance to ceftazidime and cefepime, CTX-M-55 should be considered when treating UTIs in Korea.
{"title":"Molecular and Microbiological Characteristics of Uropathogenic Escherichia coli Harboring CTX-M-55.","authors":"Heejeong Kwon,Jeoungyeon Kim,Jinnam Kim,Se Yoon Park,Choseok Yoon,Yangsoon Lee,Bongyoung Kim","doi":"10.3343/alm.2025.0288","DOIUrl":"https://doi.org/10.3343/alm.2025.0288","url":null,"abstract":"The extended-spectrum β-lactamase (ESBL) CTX-M-55, a CTX-M-15 variant distinguished by an amino-acid substitution (Ala77Val), has enhanced enzymatic activity due to higher structural stability. In Korea, CTX-M-55 remains insufficiently characterized, particularly in the context of urinary tract infections (UTIs). We identified CTX-M-55 among uropathogenic Escherichia coli isolates and compared its microbiological characteristics with those of CTX-M-15. In total, 247 E. coli isolates were collected from patients with acute pyelonephritis at Hanyang University Seoul Hospital, an 860-bed tertiary-care hospital, between July 2019 and December 2021. ESBL production was confirmed using a double-disk synergy test, and minimum inhibitory concentrations (MICs) were determined. Resistance genes were detected using PCR, and CTX-M-15 sequences were analyzed. Among 38 isolates detected using PCR, eight were confirmed as CTX-M-55 using further sequence analysis. CTX-M-55 showed (P >0.05) a trend toward increased resistance to aztreonam, cefotaxime, ceftazidime, and cefepime, while showing decreased resistance to amoxicillin/clavulanate and piperacillin/tazobactam. CTX-M-55 had higher MIC50 values than CTX-M-15 for ceftazidime (>16 vs. 8 μg/mL), cefepime (32 vs. 1 μg/mL), and piperacillin/tazobactam (0.5 vs. 0.25 μg/mL). Virulence factors and coexisting resistance genes did not significantly differ. Our findings suggest that, given its increased resistance to ceftazidime and cefepime, CTX-M-55 should be considered when treating UTIs in Korea.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"250 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145956217","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}
Jinyoung Yang,Jae-Hoon Ko,Sanghoon Lee,Dong Hyun Sinn,Jongman Kim,Kyeongman Jeon,Jae Berm Park,Jin-Oh Choi,Wooseong Huh,Yae-Jean Kim,Eun-Suk Kang,Seung Hoo Lee,Min Seo Kang,Kyungmin Huh,Sun Young Cho,Cheol-In Kang,Doo Ryeon Chung,Kyong Ran Peck
BackgroundWith increasing solid organ transplantations (SOTs), updated sero-immunological data are essential, as immune profiles shift across generations and influence preventive strategies. We aimed to evaluate the current sero-immunological status of SOT recipients in Korea.MethodsWe retrospectively analyzed pre-transplant sero-immunological test results for 12 infectious diseases from SOT recipients and donors at a single center over 20 yrs. All serological test results obtained during pre-transplant evaluations were included; identical results from repeat tests conducted within 1 yr were excluded. Temporal trends in seropositivity were assessed based on test year, age at testing, and birth cohort.ResultsIn total, 51,096 pre-transplant serological test results (35,159 from recipients and 15,937 from donors) were analyzed. Seropositivity rates remained stable throughout the test year, except for a decline for tuberculosis-specific interferon-gamma release assay (TB IGRA). By birth cohort, seropositivity for varicella-zoster virus (98.8%), herpes simplex virus (HSV; 95.7%), and cytomegalovirus (CMV, 99.4%) was high in individuals born before the 1980s but declined in younger cohorts (69.3%, 46.6%, and 81.1%, respectively; all P < 0.001). The overall proportions of donor-positive/recipient-negative transplantation remained stable (CMV 1.3%, HSV 3.8%, and Epstein-Barr virus 2.5%). Seropositivity for hepatitis A virus and measles decreased markedly in individuals born after the 1980s (35.7% and 77.9%, respectively) compared with those born earlier (84.3% and 94.1%; both P < 0.001). Toxoplasma antibody and TB IGRA positivity (both P <0.001) demonstrated significant age-dependent declines across SOT recipients.ConclusionsThe sero-immunological landscape of SOT candidates has changed over time, reflecting generational shifts in Korean society. These changes highlight the importance of targeted screening and tailored management, particularly for high-risk donor-seropositive/recipient-seronegative transplantations, as well as the critical need for timely immunization in transplant candidates.
{"title":"Changes in Sero-Immunological Status for Infectious Diseases in Solid Organ Transplantation: A 20-year Single-Center Study in Korea.","authors":"Jinyoung Yang,Jae-Hoon Ko,Sanghoon Lee,Dong Hyun Sinn,Jongman Kim,Kyeongman Jeon,Jae Berm Park,Jin-Oh Choi,Wooseong Huh,Yae-Jean Kim,Eun-Suk Kang,Seung Hoo Lee,Min Seo Kang,Kyungmin Huh,Sun Young Cho,Cheol-In Kang,Doo Ryeon Chung,Kyong Ran Peck","doi":"10.3343/alm.2025.0459","DOIUrl":"https://doi.org/10.3343/alm.2025.0459","url":null,"abstract":"BackgroundWith increasing solid organ transplantations (SOTs), updated sero-immunological data are essential, as immune profiles shift across generations and influence preventive strategies. We aimed to evaluate the current sero-immunological status of SOT recipients in Korea.MethodsWe retrospectively analyzed pre-transplant sero-immunological test results for 12 infectious diseases from SOT recipients and donors at a single center over 20 yrs. All serological test results obtained during pre-transplant evaluations were included; identical results from repeat tests conducted within 1 yr were excluded. Temporal trends in seropositivity were assessed based on test year, age at testing, and birth cohort.ResultsIn total, 51,096 pre-transplant serological test results (35,159 from recipients and 15,937 from donors) were analyzed. Seropositivity rates remained stable throughout the test year, except for a decline for tuberculosis-specific interferon-gamma release assay (TB IGRA). By birth cohort, seropositivity for varicella-zoster virus (98.8%), herpes simplex virus (HSV; 95.7%), and cytomegalovirus (CMV, 99.4%) was high in individuals born before the 1980s but declined in younger cohorts (69.3%, 46.6%, and 81.1%, respectively; all P < 0.001). The overall proportions of donor-positive/recipient-negative transplantation remained stable (CMV 1.3%, HSV 3.8%, and Epstein-Barr virus 2.5%). Seropositivity for hepatitis A virus and measles decreased markedly in individuals born after the 1980s (35.7% and 77.9%, respectively) compared with those born earlier (84.3% and 94.1%; both P < 0.001). Toxoplasma antibody and TB IGRA positivity (both P <0.001) demonstrated significant age-dependent declines across SOT recipients.ConclusionsThe sero-immunological landscape of SOT candidates has changed over time, reflecting generational shifts in Korean society. These changes highlight the importance of targeted screening and tailored management, particularly for high-risk donor-seropositive/recipient-seronegative transplantations, as well as the critical need for timely immunization in transplant candidates.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"47 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145956067","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}
BackgroundBlood RNA sequencing (RNA-seq) is increasingly used to enhance diagnostic yield in genetic disorders; however, technical optimization is critical for clinical implementation. We evaluated key technical considerations for blood RNA-seq, including globin depletion methods, inter-batch variability, and sample types (whole blood vs. isolated peripheral blood mononuclear cells [PBMCs]).MethodsWe compared the applicability of reagent-based globin removal (globin-RR) with bioinformatic globin removal (globin-BR) in whole-blood RNA-seq in terms of globin depletion efficiency and required sequencing depth, assessed batch effects in globin-RR samples using principal component and correlation analyses, and compared the use of whole blood versus PBMCs in terms of expression correlations and the number of detected Mendelian disease-associated genes.ResultsGlobin-RR performed better than globin-BR, achieved better coverage of clinically relevant Mendelian disease-associated genes (51.85% vs. 40.79%), and required fewer total sequencing reads (mean, ~107 vs. ~149 million) to obtain 100 million non-globin reads. Batch effects of globin-RR were low (inter-batch correlation, R2>0.96). PBMCs out-performed whole blood in terms of the number of Mendelian disease-associated genes (3,675 in PBMCs vs. 3,598 in whole blood) and percentage of highly expressed (transcripts per million >5) Mendelian disease-associated genes (54.46% vs. 51.85%) detected and therefore was the preferred sample type for RNA-seq.ConclusionsGlobin-RR is effective, reproducible, and practical for use in clinical whole-blood RNA-seq. With high concordance and a slightly broader gene detection range than whole blood, PBMCs are a viable alternative sample type for routine genetic diagnostic tests.
{"title":"Technical Considerations for Blood RNA Sequencing in Genetic Testing: Evaluation of Globin Depletion Methods, Batch Effects, and Sample Types.","authors":"Xinyi Lu,Yumeng Ma,Xiaomei Luo,Xiaoyan Huo,Jie Wang,Yi Liu,Huili Liu,Ting Xu,Qianfeng Zhao,Yongguo Yu,Yanjie Fan","doi":"10.3343/alm.2025.0434","DOIUrl":"https://doi.org/10.3343/alm.2025.0434","url":null,"abstract":"BackgroundBlood RNA sequencing (RNA-seq) is increasingly used to enhance diagnostic yield in genetic disorders; however, technical optimization is critical for clinical implementation. We evaluated key technical considerations for blood RNA-seq, including globin depletion methods, inter-batch variability, and sample types (whole blood vs. isolated peripheral blood mononuclear cells [PBMCs]).MethodsWe compared the applicability of reagent-based globin removal (globin-RR) with bioinformatic globin removal (globin-BR) in whole-blood RNA-seq in terms of globin depletion efficiency and required sequencing depth, assessed batch effects in globin-RR samples using principal component and correlation analyses, and compared the use of whole blood versus PBMCs in terms of expression correlations and the number of detected Mendelian disease-associated genes.ResultsGlobin-RR performed better than globin-BR, achieved better coverage of clinically relevant Mendelian disease-associated genes (51.85% vs. 40.79%), and required fewer total sequencing reads (mean, ~107 vs. ~149 million) to obtain 100 million non-globin reads. Batch effects of globin-RR were low (inter-batch correlation, R2>0.96). PBMCs out-performed whole blood in terms of the number of Mendelian disease-associated genes (3,675 in PBMCs vs. 3,598 in whole blood) and percentage of highly expressed (transcripts per million >5) Mendelian disease-associated genes (54.46% vs. 51.85%) detected and therefore was the preferred sample type for RNA-seq.ConclusionsGlobin-RR is effective, reproducible, and practical for use in clinical whole-blood RNA-seq. With high concordance and a slightly broader gene detection range than whole blood, PBMCs are a viable alternative sample type for routine genetic diagnostic tests.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"21 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145956085","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}
Pub Date : 2026-01-01Epub Date: 2025-11-06DOI: 10.3343/alm.2025.0543
Hyun-Young Kim, Jae Joon Lee, Min-Seung Park, Chang-Hun Park, Taek Kyu Park, Sung-A Chang, Hee-Jin Kim
{"title":"Klinefelter Syndrome Identified by Next-generation Sequencing as a Risk Factor for Venous Thromboembolism: A Single-institution Study.","authors":"Hyun-Young Kim, Jae Joon Lee, Min-Seung Park, Chang-Hun Park, Taek Kyu Park, Sung-A Chang, Hee-Jin Kim","doi":"10.3343/alm.2025.0543","DOIUrl":"10.3343/alm.2025.0543","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"115-117"},"PeriodicalIF":3.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12698240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145450589","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}
Pub Date : 2026-01-01Epub Date: 2025-06-04DOI: 10.3343/alm.2025.0017
Changhee Ha, Yeon Jae Lee, Jong Do Seo, Hanah Kim, Hee-Won Moon, Mina Hur, Young Hwan Lee, Sang O Park, Kyeong Ryong Lee, Hyun-Joong Kim, Yeo-Min Yun
Background: The 2020 European Society of Cardiology (ESC) 0-hr/1-hr algorithm using high-sensitivity cardiac troponin I (hs-cTnI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) aims at early diagnosis and shorter emergency department (ED) stays. While this algorithm has been well-established in controlled studies, real-world implementation remains challenging. We evaluated the algorithm's clinical performance and risk stratification capability in patients with chest pain or discomfort.
Methods: We measured hs-cTnI in 4,678 patients suspected of NSTE-ACS between August 2022 and July 2023, using an Atellica IM Analyzer (Siemens Healthineers, Erlangen, Germany). We categorized patients into rule-in, observe, or rule-out groups according to the algorithm and assessed its diagnostic performance for NSTE-ACS. The final diagnosis of NSTE-ACS was adjudicated by two independent physicians. Additionally, we evaluated 30-day all-cause mortality, hazard risk, and ED length of stay across the three groups.
Results: The algorithm categorized 3,408 (72.9%), 573 (12.2%), and 697 (14.9%) patients into the rule-out, observe, and rule-in groups, respectively. Among 90 patients diagnosed as having NSTE-ACS, none were falsely categorized into the rule-out group. Survival analysis revealed significant differences (P <0.001), with Cox hazard ratios of 2.38 (95% confidence interval: 1.20-4.71) and 6.39 (3.45-11.86) in the observe and rule-in groups, respectively. ED stays shortened in the order of rule-out, observe, and rule-in groups (P <0.001).
Conclusions: The 2020 ESC 0-hr/1-hr algorithm demonstrates excellent diagnostic accuracy without false rule-outs and effective risk stratification, and contributes to efficient ED throughput, supporting its clinical utility in real-world emergency settings.
{"title":"Performance Evaluation of the 2020 European Society of Cardiology 0-hour/1-hour Algorithm Using High-sensitivity Cardiac Troponin I for Non-ST-segment Elevation Acute Coronary Syndrome and Mortality Assessment Based on 1-year Real-world Data.","authors":"Changhee Ha, Yeon Jae Lee, Jong Do Seo, Hanah Kim, Hee-Won Moon, Mina Hur, Young Hwan Lee, Sang O Park, Kyeong Ryong Lee, Hyun-Joong Kim, Yeo-Min Yun","doi":"10.3343/alm.2025.0017","DOIUrl":"10.3343/alm.2025.0017","url":null,"abstract":"<p><strong>Background: </strong>The 2020 European Society of Cardiology (ESC) 0-hr/1-hr algorithm using high-sensitivity cardiac troponin I (hs-cTnI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) aims at early diagnosis and shorter emergency department (ED) stays. While this algorithm has been well-established in controlled studies, real-world implementation remains challenging. We evaluated the algorithm's clinical performance and risk stratification capability in patients with chest pain or discomfort.</p><p><strong>Methods: </strong>We measured hs-cTnI in 4,678 patients suspected of NSTE-ACS between August 2022 and July 2023, using an Atellica IM Analyzer (Siemens Healthineers, Erlangen, Germany). We categorized patients into rule-in, observe, or rule-out groups according to the algorithm and assessed its diagnostic performance for NSTE-ACS. The final diagnosis of NSTE-ACS was adjudicated by two independent physicians. Additionally, we evaluated 30-day all-cause mortality, hazard risk, and ED length of stay across the three groups.</p><p><strong>Results: </strong>The algorithm categorized 3,408 (72.9%), 573 (12.2%), and 697 (14.9%) patients into the rule-out, observe, and rule-in groups, respectively. Among 90 patients diagnosed as having NSTE-ACS, none were falsely categorized into the rule-out group. Survival analysis revealed significant differences (<i>P</i> <0.001), with Cox hazard ratios of 2.38 (95% confidence interval: 1.20-4.71) and 6.39 (3.45-11.86) in the observe and rule-in groups, respectively. ED stays shortened in the order of rule-out, observe, and rule-in groups (<i>P</i> <0.001).</p><p><strong>Conclusions: </strong>The 2020 ESC 0-hr/1-hr algorithm demonstrates excellent diagnostic accuracy without false rule-outs and effective risk stratification, and contributes to efficient ED throughput, supporting its clinical utility in real-world emergency settings.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"52-61"},"PeriodicalIF":3.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12698244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214716","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}
BackgroundCandida lusitaniae, currently taxonomically classified as Clavispora lusitaniae, is a candidemia due to non-albicans Candida species, featuring unusual antifungal susceptibility profile and rapid resistance acquisition. This multicenter cohort study aimed to identify mortality risk factors in Korean patients with C. lusitaniae candidemia.MethodsWe retrospectively analyzed 53 C. lusitaniae candidemia cases from six university hospitals in Korea between January 2019 and December 2024. Demographic and clinical characteristics were compared between survivors and patients who died during their hospital stay (non-survivors). Univariate and multivariate Cox regression analyses were conducted to determine independent risk factors for 30- and 60-day mortality.ResultsDuring the study period, C. lusitaniae was the fifth most common cause of candidemia. The overall in-hospital mortality was 69.8%, with 30- and 60-day mortality rates of 39.6% and 47.2%, respectively. The non-survivor group comprised a significantly higher proportion of patients with lymphoma and those receiving immunosuppressive therapy. Independent risk factors for 30-day mortality included severe sepsis (hazard ratio 9.02), intensive care unit (ICU) admission (3.32), total parenteral nutrition use (7.60), moderate-to-severe kidney disease (3.34), fluconazole non-wild type (WT) isolates (105.06), and amphotericin B non-WT or multidrug-resistant (MDR) isolates (11.83). For 60-day mortality, independent risk factors were severe sepsis (3.66), ICU admission (3.44), moderate-to-severe kidney disease (2.72), fluconazole non-WT isolates (91.23), and amphotericin B non-WT or MDR isolates (8.63).ConclusionsMDR or non-WT isolates, along with host factors such as severe sepsis, are associated with a worse prognosis in C. lusitaniae candidemia in Korea. These findings highlight the need for careful monitoring and management of high-risk patients.
{"title":"Clinical Characteristics and Mortality Risk Factors of Candida lusitaniae Candidemia: A Multicenter Study in Korea.","authors":"Tae Yeul Kim,Jung-Hyun Byun,Changseung Liu,Dahae Yang,Hyun-Seung Lee,Heungsup Sung,Mi-Na Kim,Eun Jeong Won","doi":"10.3343/alm.2025.0320","DOIUrl":"https://doi.org/10.3343/alm.2025.0320","url":null,"abstract":"BackgroundCandida lusitaniae, currently taxonomically classified as Clavispora lusitaniae, is a candidemia due to non-albicans Candida species, featuring unusual antifungal susceptibility profile and rapid resistance acquisition. This multicenter cohort study aimed to identify mortality risk factors in Korean patients with C. lusitaniae candidemia.MethodsWe retrospectively analyzed 53 C. lusitaniae candidemia cases from six university hospitals in Korea between January 2019 and December 2024. Demographic and clinical characteristics were compared between survivors and patients who died during their hospital stay (non-survivors). Univariate and multivariate Cox regression analyses were conducted to determine independent risk factors for 30- and 60-day mortality.ResultsDuring the study period, C. lusitaniae was the fifth most common cause of candidemia. The overall in-hospital mortality was 69.8%, with 30- and 60-day mortality rates of 39.6% and 47.2%, respectively. The non-survivor group comprised a significantly higher proportion of patients with lymphoma and those receiving immunosuppressive therapy. Independent risk factors for 30-day mortality included severe sepsis (hazard ratio 9.02), intensive care unit (ICU) admission (3.32), total parenteral nutrition use (7.60), moderate-to-severe kidney disease (3.34), fluconazole non-wild type (WT) isolates (105.06), and amphotericin B non-WT or multidrug-resistant (MDR) isolates (11.83). For 60-day mortality, independent risk factors were severe sepsis (3.66), ICU admission (3.44), moderate-to-severe kidney disease (2.72), fluconazole non-WT isolates (91.23), and amphotericin B non-WT or MDR isolates (8.63).ConclusionsMDR or non-WT isolates, along with host factors such as severe sepsis, are associated with a worse prognosis in C. lusitaniae candidemia in Korea. These findings highlight the need for careful monitoring and management of high-risk patients.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"29 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145830343","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}
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