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}
Seung Hoo Lee,Tae Yeul Kim,Jinyoung Yang,Kyungmin Huh,Sun Young Cho,Cheol-In Kang,Doo Ryeon Chung,Kyong Ran Peck,Sunghae Park,Kyo Won Lee,Jae Berm Park,Namkee Oh,Jinsoo Rhu,Gyu-Seong Choi,Jongman Kim,Wooseong Huh,Hee Jae Huh,Eun-Suk Kang,Jae-Hoon Ko
BackgroundCytomegalovirus (CMV) antigenemia assay (AG) and whole-blood (WB) quantitative (q)PCR have long been used for monitoring CMV reactivation in solid organ transplant (SOT) recipients. Automated plasma qPCR has enabled faster turnaround and timely intervention. We compared automated plasma qPCR with conventional methods to determine CMV pre-emptive therapy thresholds.MethodsIn this single-center retrospective study, liver transplant (LT) and kidney transplant (KT) recipients underwent AG, WB qPCR, and plasma qPCR on the same day. Correlations between these assays were assessed using Spearman's rank correlation, linear, and Tobit regression. qPCR performance was evaluated using ROC analysis, with AG thresholds as the reference standard.ResultsIn total, 618 samples from 248 patients were analyzed. WB and plasma qPCR viral loads showed strong correlation (Spearman ρ=0.854, P <0.001), with higher viral loads in WB. Among 317 samples with quantifiable CMV DNA in both assays, WB (β=0.81; R2=0.371) and plasma (β=0.77; R2=0.387) qPCR showed moderate correlations with AG (P <0.001). A linear regression equation was derived: log10 (plasma DNA [IU/mL])= 0.77×log10 (AG cells/200,000 white blood cells)+2.81. Based on AG thresholds ( ≥ 5 for LT; ≥ 25 for KT), clinical feasibility, and treatment burden, institutional plasma qPCR thresholds of 2,000 IU/mL (LT) and 10,000 IU/mL (KT) were established.ConclusionsBy establishing organ-specific plasma qPCR thresholds, this study provides a framework for transitioning from AG- or WB-based monitoring to automated plasma qPCR-guided CMV surveillance.
{"title":"Transition from Cytomegalovirus Antigenemia Assay and Whole-Blood Quantitative PCR to Automated Plasma Quantitative PCR in Solid Organ Transplant Recipients: Correlation of Viral Loads and Impact on Treatment Eligibility Based on a Single-Center Retrospective Study.","authors":"Seung Hoo Lee,Tae Yeul Kim,Jinyoung Yang,Kyungmin Huh,Sun Young Cho,Cheol-In Kang,Doo Ryeon Chung,Kyong Ran Peck,Sunghae Park,Kyo Won Lee,Jae Berm Park,Namkee Oh,Jinsoo Rhu,Gyu-Seong Choi,Jongman Kim,Wooseong Huh,Hee Jae Huh,Eun-Suk Kang,Jae-Hoon Ko","doi":"10.3343/alm.2025.0376","DOIUrl":"https://doi.org/10.3343/alm.2025.0376","url":null,"abstract":"BackgroundCytomegalovirus (CMV) antigenemia assay (AG) and whole-blood (WB) quantitative (q)PCR have long been used for monitoring CMV reactivation in solid organ transplant (SOT) recipients. Automated plasma qPCR has enabled faster turnaround and timely intervention. We compared automated plasma qPCR with conventional methods to determine CMV pre-emptive therapy thresholds.MethodsIn this single-center retrospective study, liver transplant (LT) and kidney transplant (KT) recipients underwent AG, WB qPCR, and plasma qPCR on the same day. Correlations between these assays were assessed using Spearman's rank correlation, linear, and Tobit regression. qPCR performance was evaluated using ROC analysis, with AG thresholds as the reference standard.ResultsIn total, 618 samples from 248 patients were analyzed. WB and plasma qPCR viral loads showed strong correlation (Spearman ρ=0.854, P <0.001), with higher viral loads in WB. Among 317 samples with quantifiable CMV DNA in both assays, WB (β=0.81; R2=0.371) and plasma (β=0.77; R2=0.387) qPCR showed moderate correlations with AG (P <0.001). A linear regression equation was derived: log10 (plasma DNA [IU/mL])= 0.77×log10 (AG cells/200,000 white blood cells)+2.81. Based on AG thresholds ( ≥ 5 for LT; ≥ 25 for KT), clinical feasibility, and treatment burden, institutional plasma qPCR thresholds of 2,000 IU/mL (LT) and 10,000 IU/mL (KT) were established.ConclusionsBy establishing organ-specific plasma qPCR thresholds, this study provides a framework for transitioning from AG- or WB-based monitoring to automated plasma qPCR-guided CMV surveillance.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"20 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145777387","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}
BackgroundAutoimmune nodopathy (AN) is a disabling peripheral nerve disorder mediated by four pathogenic autoantibodies targeting the node of Ranvier: anti-neurofascin-155 (Nfasc155); anti-Nfasc155 and Nfasc186 (PanNfasc); anti-contactin-1; and anti-contactin-associated protein 1 autoantibodies. Several autoantibody detection assays exist; however, which assay yields the best performance remains unclear. We evaluated the performance of five diagnostic assays individually and in combinations to identify a gold standard assay for diagnosing AN and improve diagnostic accuracy.MethodsSera from 290 individuals from a European cohort, including healthy controls and patients with Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, monoclonal gammopathy, Charcot-Marie-Tooth disease, and AN were tested using five diagnostic assays for AN: ImmunoDOT (D-tek, Mons, Belgium); ELISA; an in-house cell-based assay (CBA); a commercial CBA (Euroimmun, Bussy-Saint-Martin, France); and peripheral nerve immunohistochemistry (IHC). The sensitivity (Se) and specificity (Sp) of the individual assays and their combinations were estimated using Bayesian latent class analysis.ResultsThe overall Se was 84% (95% credibility interval [CI], 79-88) for ImmunoDOT, 86% (81-90) for ELISA, 96% (93-98) for the in-house CBA, 92% (89-96) for the commercial CBA, and 91% (87-94) for IHC. For all assays, the overall Sp was ≥ 97%. Among the tested assays, in-house CBA showed the best performance, with the highest Se and Sp. The assay combinations demonstrated excellent analytical performance (Se ≥ 91% and Sp ≥ 98%). Inter-laboratory validation revealed excellent repeatability, with a Gwet's agreement coefficient of >0.94 for most assays.ConclusionsOur research suggests that combining two assays, CBA and ImmunoDOT enhances the accuracy of AN diagnosis. This approach can facilitate the establishment of standardized assays for AN diagnosis and aid in the better differentiation of AN from other similar pathologies.
{"title":"Comparative Analytical Performance of Autoimmune Nodopathy Diagnostic Assays.","authors":"Alexandre Jentzer,Chris Serrand,Elisa Vegezzi,Killian Gilavet,Jérémie El-Bechir,Bianca Rugginini,Chiara Morandi,Thierry Vincent,Guillaume Taieb,Matteo Gastaldi,Jérôme Joël Devaux","doi":"10.3343/alm.2025.0534","DOIUrl":"https://doi.org/10.3343/alm.2025.0534","url":null,"abstract":"BackgroundAutoimmune nodopathy (AN) is a disabling peripheral nerve disorder mediated by four pathogenic autoantibodies targeting the node of Ranvier: anti-neurofascin-155 (Nfasc155); anti-Nfasc155 and Nfasc186 (PanNfasc); anti-contactin-1; and anti-contactin-associated protein 1 autoantibodies. Several autoantibody detection assays exist; however, which assay yields the best performance remains unclear. We evaluated the performance of five diagnostic assays individually and in combinations to identify a gold standard assay for diagnosing AN and improve diagnostic accuracy.MethodsSera from 290 individuals from a European cohort, including healthy controls and patients with Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, monoclonal gammopathy, Charcot-Marie-Tooth disease, and AN were tested using five diagnostic assays for AN: ImmunoDOT (D-tek, Mons, Belgium); ELISA; an in-house cell-based assay (CBA); a commercial CBA (Euroimmun, Bussy-Saint-Martin, France); and peripheral nerve immunohistochemistry (IHC). The sensitivity (Se) and specificity (Sp) of the individual assays and their combinations were estimated using Bayesian latent class analysis.ResultsThe overall Se was 84% (95% credibility interval [CI], 79-88) for ImmunoDOT, 86% (81-90) for ELISA, 96% (93-98) for the in-house CBA, 92% (89-96) for the commercial CBA, and 91% (87-94) for IHC. For all assays, the overall Sp was ≥ 97%. Among the tested assays, in-house CBA showed the best performance, with the highest Se and Sp. The assay combinations demonstrated excellent analytical performance (Se ≥ 91% and Sp ≥ 98%). Inter-laboratory validation revealed excellent repeatability, with a Gwet's agreement coefficient of >0.94 for most assays.ConclusionsOur research suggests that combining two assays, CBA and ImmunoDOT enhances the accuracy of AN diagnosis. This approach can facilitate the establishment of standardized assays for AN diagnosis and aid in the better differentiation of AN from other similar pathologies.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"111 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145777388","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}
Howon Lee,Gun Dong Lee,Dong Wook Jekarl,Myungshin Kim,Yonggoo Kim
BackgroundData on human leukocyte antigen (HLA) typing using modern high-resolution methods are increasingly needed. Previous HLA studies in Korea were limited by small sample sizes or low-resolution data. We analyzed high-resolution (eight-digit) HLA data obtained through next-generation sequencing from healthy volunteers from Korea registered for hematopoietic stem cell transplantation, providing a large-scale dataset for population-based genetic analysis.MethodsWe comprehensively analyzed HLA data from 2,726 volunteers from Korea. HLA-A, -B, -C, and -DRB1 alleles were identified using a GenDX NGSgo kit. Allele frequency (AF), haplotype frequency (HF), and equilibrium status were analyzed using the PyPop software. Principal component, Euclidean distance, and Nei's standard genetic distance analyses were performed using R software to compare data from Korea with that from other East Asian populations.ResultsAF analysis identified 222 alleles (52 HLA-A, 70 HLA-B, 59 HLA-C, and 41 HLA-DRB1); HLA-A*24:02:01:01, HLA-B*15:01:01:01, HLA-C*01:02:01:01, and HLA-DRB1* 09:01:02:01 were the most common. HF analysis revealed 632 haplotypes in HLA class I, and 2,848 in combined classes I and II; HLA-A*33:03:01:01~B*44:03:01:0 1~C*14:03:01:01 and HLA-A*33:03:01:01~B*44:03:01:01~C*14:03:01:01~ DRB1*13:02:01:02 were the most common. Principal component and Euclidean distance analyses revealed genetic similarities among the individuals from Korea, Japan, and China.ConclusionsThis study revealed key population genetic trends and relationships with East Asian neighbors, reflecting both shared and distinctive HLA characteristics. These data can provide valuable insights for anthropological and clinicopathological studies, as well as for understanding genetic diversity within the East Asian region.
{"title":"High-Resolution Eight-Digit Human Leukocyte Antigen-A, -B, -C, and -DRB1 Allele and Haplotype Frequencies in South Koreans Using Next-Generation Sequencing.","authors":"Howon Lee,Gun Dong Lee,Dong Wook Jekarl,Myungshin Kim,Yonggoo Kim","doi":"10.3343/alm.2025.0393","DOIUrl":"https://doi.org/10.3343/alm.2025.0393","url":null,"abstract":"BackgroundData on human leukocyte antigen (HLA) typing using modern high-resolution methods are increasingly needed. Previous HLA studies in Korea were limited by small sample sizes or low-resolution data. We analyzed high-resolution (eight-digit) HLA data obtained through next-generation sequencing from healthy volunteers from Korea registered for hematopoietic stem cell transplantation, providing a large-scale dataset for population-based genetic analysis.MethodsWe comprehensively analyzed HLA data from 2,726 volunteers from Korea. HLA-A, -B, -C, and -DRB1 alleles were identified using a GenDX NGSgo kit. Allele frequency (AF), haplotype frequency (HF), and equilibrium status were analyzed using the PyPop software. Principal component, Euclidean distance, and Nei's standard genetic distance analyses were performed using R software to compare data from Korea with that from other East Asian populations.ResultsAF analysis identified 222 alleles (52 HLA-A, 70 HLA-B, 59 HLA-C, and 41 HLA-DRB1); HLA-A*24:02:01:01, HLA-B*15:01:01:01, HLA-C*01:02:01:01, and HLA-DRB1* 09:01:02:01 were the most common. HF analysis revealed 632 haplotypes in HLA class I, and 2,848 in combined classes I and II; HLA-A*33:03:01:01~B*44:03:01:0 1~C*14:03:01:01 and HLA-A*33:03:01:01~B*44:03:01:01~C*14:03:01:01~ DRB1*13:02:01:02 were the most common. Principal component and Euclidean distance analyses revealed genetic similarities among the individuals from Korea, Japan, and China.ConclusionsThis study revealed key population genetic trends and relationships with East Asian neighbors, reflecting both shared and distinctive HLA characteristics. These data can provide valuable insights for anthropological and clinicopathological studies, as well as for understanding genetic diversity within the East Asian region.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"21 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145771336","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}
Su Man Kim,Si Hyun Kim,Eun-Young Kim,So Dam Shin,Hyeon Jin Choi,Eunkyoung You,Ja Young Lee,Seok Hoon Jeong,Dokyun Kim,Hyun Soo Kim,Soo Hyun Kim,Young Ah Kim,Young Ree Kim,Nam Hee Ryoo,Jong Hee Shin,Kyeong Seob Shin,Young Uh,Jeong Hwan Shin
BackgroundSalmonella is one of the main pathogens causing food-borne infectious diseaseS. We investigated the serotype distribution and antimicrobial resistance of Salmonella isolates in Korea obtained between 2018 and 2022.MethodsWe studied 965 Salmonella isolates from nine university hospitals across Korea. Serotypes were determined following the Kauffmann-White scheme, and antimicrobial susceptibility tests were performed using Sensititre KRCDC2F susceptibility testing plateS.ResultsOf the 965 isolates, 732 (75.9%) were isolated from stool specimens, and 233 (24.1%) were isolated from blood specimenS. We identified 58 different serotypeS. The five most frequent serotypes detected were S. serovar Enteritidis (N=207; 21.5%), S. serovar I 4,[5],12:i:- (N=200; 20.7%), S. serovar Infantis (N=88; 9.1%), S. serovar Bareilly (N=77; 8.0%), and S. serovar Typhimurium (N=69; 7.2%). The 10 most common serotypes accounted for 79.4% of all isolateS. The resistance rates to ampicillin, chloramphenicol, trimethoprim-sulfamethoxazole, cefotaxime, and ceftriaxone were 33.2%, 11.1%, 8.2%, 8.6%, and 8.3%, respectively. Although only 3.0% of Salmonella isolates were resistant to ciprofloxacin, the intermediate resistance rate was 32.8%. We observed ciprofloxacin non-susceptibility (93.7%) in S. Enteritidis, ciprofloxacin resistance (83.3%) in S. serovar Paratyphi A, and extensive drug resistance (10.0%) in S. serovar Typhi. The overall rates of multidrug and extensive drug resistance were 6.2% (N=60) and 2.0% (N=19), respectively.ConclusionsContinuous monitoring of Salmonella serotypes for antimicrobial resistance is necessary for appropriate patient management.
{"title":"Serotype Distribution and Antimicrobial Resistance of Salmonella in Korea Between 2018 and 2022.","authors":"Su Man Kim,Si Hyun Kim,Eun-Young Kim,So Dam Shin,Hyeon Jin Choi,Eunkyoung You,Ja Young Lee,Seok Hoon Jeong,Dokyun Kim,Hyun Soo Kim,Soo Hyun Kim,Young Ah Kim,Young Ree Kim,Nam Hee Ryoo,Jong Hee Shin,Kyeong Seob Shin,Young Uh,Jeong Hwan Shin","doi":"10.3343/alm.2025.0412","DOIUrl":"https://doi.org/10.3343/alm.2025.0412","url":null,"abstract":"BackgroundSalmonella is one of the main pathogens causing food-borne infectious diseaseS. We investigated the serotype distribution and antimicrobial resistance of Salmonella isolates in Korea obtained between 2018 and 2022.MethodsWe studied 965 Salmonella isolates from nine university hospitals across Korea. Serotypes were determined following the Kauffmann-White scheme, and antimicrobial susceptibility tests were performed using Sensititre KRCDC2F susceptibility testing plateS.ResultsOf the 965 isolates, 732 (75.9%) were isolated from stool specimens, and 233 (24.1%) were isolated from blood specimenS. We identified 58 different serotypeS. The five most frequent serotypes detected were S. serovar Enteritidis (N=207; 21.5%), S. serovar I 4,[5],12:i:- (N=200; 20.7%), S. serovar Infantis (N=88; 9.1%), S. serovar Bareilly (N=77; 8.0%), and S. serovar Typhimurium (N=69; 7.2%). The 10 most common serotypes accounted for 79.4% of all isolateS. The resistance rates to ampicillin, chloramphenicol, trimethoprim-sulfamethoxazole, cefotaxime, and ceftriaxone were 33.2%, 11.1%, 8.2%, 8.6%, and 8.3%, respectively. Although only 3.0% of Salmonella isolates were resistant to ciprofloxacin, the intermediate resistance rate was 32.8%. We observed ciprofloxacin non-susceptibility (93.7%) in S. Enteritidis, ciprofloxacin resistance (83.3%) in S. serovar Paratyphi A, and extensive drug resistance (10.0%) in S. serovar Typhi. The overall rates of multidrug and extensive drug resistance were 6.2% (N=60) and 2.0% (N=19), respectively.ConclusionsContinuous monitoring of Salmonella serotypes for antimicrobial resistance is necessary for appropriate patient management.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"16 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145771335","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}
BackgroundCoronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and seasonal influenza are responsible for recurring seasonal epidemics. We tested the accuracy of an optical waveguide-based biosensor for detecting SARS-CoV-2 and seasonal influenza viruses in nasal and nasopharyngeal specimens.MethodsWe consecutively collected 252 nasopharyngeal swabs (NPSs) and 107 nasal specimens from febrile patients with respiratory symptoms who visited two university hospitals and six clinics between January and March 2025. Point-of-care testing data from an optical waveguide-based biosensor test (Rapiim SARS-CoV-2-N/Flu) and a lateral flow test were compared with those obtained using conventional quantitative real-time reverse transcription PCR.ResultsWith NPS specimens, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 95.2% and 100%, respectively, for SARS-CoV-2 (98.8% concordance) and 92.3% and 92.2%, respectively, for seasonal influenza viruses (95.2% concordance). When nasal specimens were used, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 93.1% and 98.0%, respectively, for detecting SARS-CoV-2. The sensitivities for detecting SARS-CoV-2 and seasonal influenza were higher than a lateral flow test. The Rapiim SARS-CoV-2-N/Flu test detected SARS-CoV-2 and seasonal influenza viruses at 10 and 6 days after symptom onset, respectively.ConclusionsRapid test with greater accuracy than lateral flow tests that can differentiate between SARS-CoV-2 and influenza were needed. Point of care antigen testing using the optical waveguide-based biosensor yielded higher sensitivity and specificity for detecting SARS-CoV-2 and seasonal influenza viruses in NPS and nasal specimens than conventional tests, enabling differentiation between both types of acute respiratory infections.
由严重急性呼吸系统综合征冠状病毒-2 （SARS-CoV-2）引起的2019冠状病毒病和季节性流感是反复出现的季节性流行病的原因。我们测试了基于光波导的生物传感器检测鼻腔和鼻咽标本中SARS-CoV-2和季节性流感病毒的准确性。方法对2025年1 - 3月在2所大学附属医院和6个门诊就诊的有呼吸道症状的发热患者，连续采集鼻咽拭子252份和鼻标本107份。将基于光波导的生物传感器测试（Rapiim SARS-CoV-2-N/Flu）和侧流测试的即时检测数据与传统定量实时反转录PCR获得的数据进行了比较。结果Rapiim SARS-CoV-2- n /Flu检测对NPS标本的敏感性和特异性分别为95.2%和100%（一致性98.8%），对季节性流感病毒的敏感性和特异性分别为92.3%和92.2%（一致性95.2%）。当使用鼻腔标本时，Rapiim SARS-CoV-2- n /Flu检测SARS-CoV-2的灵敏度和特异性分别为93.1%和98.0%。检测SARS-CoV-2和季节性流感的敏感性均高于侧流试验。Rapiim SARS-CoV-2- n /Flu测试分别在症状出现后10天和6天检测SARS-CoV-2和季节性流感病毒。结论需要比侧流检测更准确的快速检测来区分SARS-CoV-2和流感。使用基于光波导的生物传感器的护理点抗原检测在NPS和鼻标本中检测SARS-CoV-2和季节性流感病毒的灵敏度和特异性高于传统检测，从而能够区分两种类型的急性呼吸道感染。
{"title":"Accuracy of an Optical Waveguide-Based Biosensor Antigen-Detection Test for Severe Acute Respiratory Syndrome Coronavirus-2 and Seasonal Influenza Viruses During the Cocirculating Season.","authors":"Hideaki Kato,Nobuko Yoshinaga,Naoko Ando,Shundai Ko,Akifumi Tokita,Toshifumi Kawashima,Akira Shoji,Yuzo Suzuki,Makoto Kudo","doi":"10.3343/alm.2025.0516","DOIUrl":"https://doi.org/10.3343/alm.2025.0516","url":null,"abstract":"BackgroundCoronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and seasonal influenza are responsible for recurring seasonal epidemics. We tested the accuracy of an optical waveguide-based biosensor for detecting SARS-CoV-2 and seasonal influenza viruses in nasal and nasopharyngeal specimens.MethodsWe consecutively collected 252 nasopharyngeal swabs (NPSs) and 107 nasal specimens from febrile patients with respiratory symptoms who visited two university hospitals and six clinics between January and March 2025. Point-of-care testing data from an optical waveguide-based biosensor test (Rapiim SARS-CoV-2-N/Flu) and a lateral flow test were compared with those obtained using conventional quantitative real-time reverse transcription PCR.ResultsWith NPS specimens, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 95.2% and 100%, respectively, for SARS-CoV-2 (98.8% concordance) and 92.3% and 92.2%, respectively, for seasonal influenza viruses (95.2% concordance). When nasal specimens were used, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 93.1% and 98.0%, respectively, for detecting SARS-CoV-2. The sensitivities for detecting SARS-CoV-2 and seasonal influenza were higher than a lateral flow test. The Rapiim SARS-CoV-2-N/Flu test detected SARS-CoV-2 and seasonal influenza viruses at 10 and 6 days after symptom onset, respectively.ConclusionsRapid test with greater accuracy than lateral flow tests that can differentiate between SARS-CoV-2 and influenza were needed. Point of care antigen testing using the optical waveguide-based biosensor yielded higher sensitivity and specificity for detecting SARS-CoV-2 and seasonal influenza viruses in NPS and nasal specimens than conventional tests, enabling differentiation between both types of acute respiratory infections.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"154 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145765531","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}
Rongrong Wang,Jia Xu,Jing Jin,Jingdi Zhang,Ziyang Huang,Peng Xia,Ye Guo,Yongzhe Li
BackgroundGlomerular hematuria (GH) is a key parameter assessed during urine analysis that is poorly identified using the automated UF-5000 system, which may misclassify GH and delay the detection of underlying glomerular diseases. We developed a light gradient boosting machine (LightGBM)-based model to improve GH detection using automated urinalysis data.MethodsWe included 5,444 urine samples from patients with positive urinary occult blood results. All samples were manually classified into non-glomerular hematuria (NGH), GH, mixed hematuria, and non-hematuria groups, based on microscopic examination. We assessed 65 parameters using UF-5000 and UC-3500 analyzers and compared their performance with that of LightGBM, extreme gradient boosting, random forest, and logistic regression models. The final model was validated through 10-fold cross-validation with an independent test set and then compared with the performance of UF-5000. SHapley Additive exPlanations were applied to identify key predictive parameters.ResultsEmploying the LightGBM model substantially improved GH recognition accuracy to 44% during validation and 37% during testing (versus 16% and 11% achieved with the UF-5000 model, respectively). Sensitivity for GH increased from 0.3 in the UF-5000 model to 0.7 in the LightGBM model. A similar increasing trend was observed for the negative predictive value (0.6 to 0.9), accuracy (0.5 to 0.8), and Cohen's kappa agreement (0.4 to over 0.6). Key predictive parameters included red blood cell count, forward scatter peak in surface channel, and urinary protein level.ConclusionsThis interpretable LightGBM-based model offers a substantial improvement in automated GH identification and is a promising tool for classifying hematuria sources.
{"title":"Enhancing Glomerular Hematuria Identification in Automated Urinalysis Using a Light Gradient Boosting Machine-Based Model: A Diagnostic Accuracy Study.","authors":"Rongrong Wang,Jia Xu,Jing Jin,Jingdi Zhang,Ziyang Huang,Peng Xia,Ye Guo,Yongzhe Li","doi":"10.3343/alm.2025.0394","DOIUrl":"https://doi.org/10.3343/alm.2025.0394","url":null,"abstract":"BackgroundGlomerular hematuria (GH) is a key parameter assessed during urine analysis that is poorly identified using the automated UF-5000 system, which may misclassify GH and delay the detection of underlying glomerular diseases. We developed a light gradient boosting machine (LightGBM)-based model to improve GH detection using automated urinalysis data.MethodsWe included 5,444 urine samples from patients with positive urinary occult blood results. All samples were manually classified into non-glomerular hematuria (NGH), GH, mixed hematuria, and non-hematuria groups, based on microscopic examination. We assessed 65 parameters using UF-5000 and UC-3500 analyzers and compared their performance with that of LightGBM, extreme gradient boosting, random forest, and logistic regression models. The final model was validated through 10-fold cross-validation with an independent test set and then compared with the performance of UF-5000. SHapley Additive exPlanations were applied to identify key predictive parameters.ResultsEmploying the LightGBM model substantially improved GH recognition accuracy to 44% during validation and 37% during testing (versus 16% and 11% achieved with the UF-5000 model, respectively). Sensitivity for GH increased from 0.3 in the UF-5000 model to 0.7 in the LightGBM model. A similar increasing trend was observed for the negative predictive value (0.6 to 0.9), accuracy (0.5 to 0.8), and Cohen's kappa agreement (0.4 to over 0.6). Key predictive parameters included red blood cell count, forward scatter peak in surface channel, and urinary protein level.ConclusionsThis interpretable LightGBM-based model offers a substantial improvement in automated GH identification and is a promising tool for classifying hematuria sources.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"15 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145765525","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}
Young Ah Kim,Hyunsoo Kim,Young Hee Seo,Kyungwon Lee
BackgroundThe spread of antimicrobial-resistant bacteria has close relationships among humans, animals, and the environment, necessitating the implementation of the "One Health" approach. In previous study, the prevalence and molecular epidemiology of extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) were investigated across multiple pig industry sectors in Korea. In this study, animal developmental stages and antimicrobial usage policies on farms were also considered.MethodsA total of 6,288 non-duplicated samples were collected from pig farms, slaughterhouses, and their personnel from three provinces in Korea between 2020 and 2022. Antimicrobial susceptibility and ESBL gene characterization were performed on the samples.ResultsOverall, 1,084 ESBL-EC isolates were collected, with positivity detection rates of 24.7%, 23.3%, 12.7%, 3.9%, 17.2% in pigs, workers, the environment, meat, and total samples, respectively. Common ESBL types were blaCTX-M-55 (N=628), blaCTX-M-15 (N=204), and blaCTX-M-14 (N=127). Pig-derived E. coli isolates had antimicrobial resistance (AMR) rates of 80.4%, 47.2%, 32.6%, 36.7%, 43.4%, 62.4%, and 72.1% to ampicillin, piperacillin, cefazoline, ciprofloxacin, cotrimoxazole, chloramphenicol, and tetracycline, respectively. AMR rates were lower in the finishing stage pigs than in the lactating stage pigs and tended to decrease during animal development for most antimicrobials. AMR rates were higher in pig farms with a customary antimicrobial use policy than in those with a low-level antimicrobial use policy.ConclusionsThe findings highlight the significance of elucidating AMR networks among humans, animals, and the environment. Prudent antimicrobial usage and continuous AMR monitoring in the pig industry are crucial to safeguard food safety.
{"title":"Prevalence and Molecular Epidemiology of Extended-Spectrum β-Lactamase-Producing Escherichia coli and Effects of Antimicrobial Use in Multiple Pig Industry Sectors in Korea.","authors":"Young Ah Kim,Hyunsoo Kim,Young Hee Seo,Kyungwon Lee","doi":"10.3343/alm.2025.0173","DOIUrl":"https://doi.org/10.3343/alm.2025.0173","url":null,"abstract":"BackgroundThe spread of antimicrobial-resistant bacteria has close relationships among humans, animals, and the environment, necessitating the implementation of the \"One Health\" approach. In previous study, the prevalence and molecular epidemiology of extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) were investigated across multiple pig industry sectors in Korea. In this study, animal developmental stages and antimicrobial usage policies on farms were also considered.MethodsA total of 6,288 non-duplicated samples were collected from pig farms, slaughterhouses, and their personnel from three provinces in Korea between 2020 and 2022. Antimicrobial susceptibility and ESBL gene characterization were performed on the samples.ResultsOverall, 1,084 ESBL-EC isolates were collected, with positivity detection rates of 24.7%, 23.3%, 12.7%, 3.9%, 17.2% in pigs, workers, the environment, meat, and total samples, respectively. Common ESBL types were blaCTX-M-55 (N=628), blaCTX-M-15 (N=204), and blaCTX-M-14 (N=127). Pig-derived E. coli isolates had antimicrobial resistance (AMR) rates of 80.4%, 47.2%, 32.6%, 36.7%, 43.4%, 62.4%, and 72.1% to ampicillin, piperacillin, cefazoline, ciprofloxacin, cotrimoxazole, chloramphenicol, and tetracycline, respectively. AMR rates were lower in the finishing stage pigs than in the lactating stage pigs and tended to decrease during animal development for most antimicrobials. AMR rates were higher in pig farms with a customary antimicrobial use policy than in those with a low-level antimicrobial use policy.ConclusionsThe findings highlight the significance of elucidating AMR networks among humans, animals, and the environment. Prudent antimicrobial usage and continuous AMR monitoring in the pig industry are crucial to safeguard food safety.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"33 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145728543","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}
Yoo-Ree Kang,Eun-Soon Son,Kyeongmin Han,Myungsun Cho,Sungwon Choi,Young Jin Kim,Jin Young Lee,JeeHey Kim,Seon Joo Kang,Jong Seok Lee,Hee Joo Lee
BackgroundTuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis (M. tuberculosis), remains a major public health concern, particularly because of the increasing incidence of drug-resistant TB. In Republic of Korea, research on genes related to TB resistance is limited; therefore, in this study, we identified resistance-associated mutations in TB clinical isolates from Republic of Korea.MethodsWe evaluated and compared phenotypic drug susceptibility testing (pDST) and genotypic drug susceptibility testing (gDST) using whole-genome sequencing (WGS) and targeted sequencing in 75 clinical M. tuberculosis isolates collected in Republic of Korea between 2005 and 2009. Specifically, we analyzed mutations associated with resistance against isoniazid (INH), rifampicin (RIF), moxifloxacin (MFX), pyrazinamide (PZA), pretomanid (PMD), delamanid (DLM), linezolid (LZD), and bedaquiline (BDQ) and compared them with those in the 2023 WHO mutation catalog.ResultsWe detected resistance-associated mutations in 98.7% of INH- and RIF-resistant isolates, with a high degree of concordance between the pDST and gDST results for most drugs. However, PZA results were discrepant for 16 isolates.ConclusionsOur findings highlight the potential of WGS and targeted sequencing as powerful tools for diagnosing TB drug resistance and emphasize the need for further validation before their routine implementation in clinical settings.
{"title":"Whole-Genome and Targeted Sequencing of 75 Drug-Resistant Mycobacterium tuberculosis Clinical Isolates in South Korea.","authors":"Yoo-Ree Kang,Eun-Soon Son,Kyeongmin Han,Myungsun Cho,Sungwon Choi,Young Jin Kim,Jin Young Lee,JeeHey Kim,Seon Joo Kang,Jong Seok Lee,Hee Joo Lee","doi":"10.3343/alm.2025.0372","DOIUrl":"https://doi.org/10.3343/alm.2025.0372","url":null,"abstract":"BackgroundTuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis (M. tuberculosis), remains a major public health concern, particularly because of the increasing incidence of drug-resistant TB. In Republic of Korea, research on genes related to TB resistance is limited; therefore, in this study, we identified resistance-associated mutations in TB clinical isolates from Republic of Korea.MethodsWe evaluated and compared phenotypic drug susceptibility testing (pDST) and genotypic drug susceptibility testing (gDST) using whole-genome sequencing (WGS) and targeted sequencing in 75 clinical M. tuberculosis isolates collected in Republic of Korea between 2005 and 2009. Specifically, we analyzed mutations associated with resistance against isoniazid (INH), rifampicin (RIF), moxifloxacin (MFX), pyrazinamide (PZA), pretomanid (PMD), delamanid (DLM), linezolid (LZD), and bedaquiline (BDQ) and compared them with those in the 2023 WHO mutation catalog.ResultsWe detected resistance-associated mutations in 98.7% of INH- and RIF-resistant isolates, with a high degree of concordance between the pDST and gDST results for most drugs. However, PZA results were discrepant for 16 isolates.ConclusionsOur findings highlight the potential of WGS and targeted sequencing as powerful tools for diagnosing TB drug resistance and emphasize the need for further validation before their routine implementation in clinical settings.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"6 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145704414","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}
Some viral infections display distinct seasonal patterns influenced by factors such as climate, human behavior, and viral characteristics. In this review, we investigated the seasonality of 15 viral infections in Korea. We analyzed viruses for which national surveillance data are available from the Korea Disease Control and Prevention Agency, including influenza virus, respiratory syncytial virus (RSV), rhinovirus, parainfluenza virus, metapneumovirus, human bocavirus, seasonal coronaviruses, enterovirus, adenovirus, norovirus, rotavirus, Japanese encephalitis virus, Hantaan virus, varicella-zoster virus, and mumps virus. In temperate climates, such as that in Korea, winter peaks are commonly observed for influenza, RSV, and norovirus infections, whereas enteroviruses are more prevalent in summer and early autumn. Parainfluenza viruses exhibit type-specific seasonality (circulating in warmer months from spring to autumn). During the coronavirus disease 2019 pandemic (2020-2021), the incidence of most respiratory and gastrointestinal viral infections analyzed in this study declined substantially owing to non-pharmaceutical interventions, such as social distancing and mask-wearing. After the preventive measures were relaxed, many viruses initially exhibited delayed or atypical seasonal peaks. However, by 2024, the seasonality of most, but not all, viral infections had largely returned to their pre-pandemic patterns. We also reviewed factors influencing viral seasonality, including climatic conditions, vector activity, human behavior, immunity, and viral genetic variation. These findings highlight the dynamic nature of viral seasonality and reinforce the importance of timely surveillance and flexible public health responses tailored to each country's epidemiological landscape.
{"title":"Seasonal Trends of Major Respiratory, Gastrointestinal, and Other Viral Infections in Korea: An Analysis Before, During, and After the Coronavirus Disease 2019 Pandemic.","authors":"Su-Kyung Lee,Ji Hyun Kim,Hyun Soo Kim","doi":"10.3343/alm.2025.0226","DOIUrl":"https://doi.org/10.3343/alm.2025.0226","url":null,"abstract":"Some viral infections display distinct seasonal patterns influenced by factors such as climate, human behavior, and viral characteristics. In this review, we investigated the seasonality of 15 viral infections in Korea. We analyzed viruses for which national surveillance data are available from the Korea Disease Control and Prevention Agency, including influenza virus, respiratory syncytial virus (RSV), rhinovirus, parainfluenza virus, metapneumovirus, human bocavirus, seasonal coronaviruses, enterovirus, adenovirus, norovirus, rotavirus, Japanese encephalitis virus, Hantaan virus, varicella-zoster virus, and mumps virus. In temperate climates, such as that in Korea, winter peaks are commonly observed for influenza, RSV, and norovirus infections, whereas enteroviruses are more prevalent in summer and early autumn. Parainfluenza viruses exhibit type-specific seasonality (circulating in warmer months from spring to autumn). During the coronavirus disease 2019 pandemic (2020-2021), the incidence of most respiratory and gastrointestinal viral infections analyzed in this study declined substantially owing to non-pharmaceutical interventions, such as social distancing and mask-wearing. After the preventive measures were relaxed, many viruses initially exhibited delayed or atypical seasonal peaks. However, by 2024, the seasonality of most, but not all, viral infections had largely returned to their pre-pandemic patterns. We also reviewed factors influencing viral seasonality, including climatic conditions, vector activity, human behavior, immunity, and viral genetic variation. These findings highlight the dynamic nature of viral seasonality and reinforce the importance of timely surveillance and flexible public health responses tailored to each country's epidemiological landscape.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"198200 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145645047","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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