Pub Date : 2025-09-01Epub Date: 2025-04-07DOI: 10.3343/alm.2024.0581
Youngwon Nam, Hyung-Doo Park
Total laboratory automation (TLA) is a transformative solution in clinical laboratories that addresses growing demands for operational efficiency, accuracy, and rapid turnaround times in patient care. TLA integrates advanced technologies across pre-analytical, analytical, and post-analytical phases, thereby streamlining workflows, reducing manual intervention, and enhancing QC. TLA adoption is driven by factors such as increasing test volumes, the need for cost reduction and regulatory compliance, and labor shortages. Key benefits of TLA include improved accuracy through error minimization, optimized resource utilization, enhanced staff well-being, and consistent delivery of high-quality results. Leading companies, including Abbott, Roche, Siemens, and Beckman Coulter, dominate the global TLA market with innovative solutions. Recent developments incorporate artificial intelligence (AI), machine learning, robotics, and Internet-of-things technologies, which enable predictive analytics and automated data management. However, challenges remain, including high implementation costs, the need for workforce training, cybersecurity concerns, and system integration complexities. Future trends indicate that TLA will advance through enhanced AI integration, sustainable practices, and big data analytics, fostering continuous improvements in precision diagnostics and clinical outcomes. Moreover, TLA has the potential to revolutionize laboratory operations globally, driving efficiency, accuracy, and sustainability while ultimately improving patient care. Successful adoption of TLA will require strategic planning, interdisciplinary collaboration, and alignment with emerging healthcare needs. In this review, we emphasize that overcoming these challenges through innovation and robust management is essential for ensuring that TLA continues to play a vital role in modern healthcare systems.
{"title":"Revolutionizing Laboratory Practices: Pioneering Trends in Total Laboratory Automation.","authors":"Youngwon Nam, Hyung-Doo Park","doi":"10.3343/alm.2024.0581","DOIUrl":"10.3343/alm.2024.0581","url":null,"abstract":"<p><p>Total laboratory automation (TLA) is a transformative solution in clinical laboratories that addresses growing demands for operational efficiency, accuracy, and rapid turnaround times in patient care. TLA integrates advanced technologies across pre-analytical, analytical, and post-analytical phases, thereby streamlining workflows, reducing manual intervention, and enhancing QC. TLA adoption is driven by factors such as increasing test volumes, the need for cost reduction and regulatory compliance, and labor shortages. Key benefits of TLA include improved accuracy through error minimization, optimized resource utilization, enhanced staff well-being, and consistent delivery of high-quality results. Leading companies, including Abbott, Roche, Siemens, and Beckman Coulter, dominate the global TLA market with innovative solutions. Recent developments incorporate artificial intelligence (AI), machine learning, robotics, and Internet-of-things technologies, which enable predictive analytics and automated data management. However, challenges remain, including high implementation costs, the need for workforce training, cybersecurity concerns, and system integration complexities. Future trends indicate that TLA will advance through enhanced AI integration, sustainable practices, and big data analytics, fostering continuous improvements in precision diagnostics and clinical outcomes. Moreover, TLA has the potential to revolutionize laboratory operations globally, driving efficiency, accuracy, and sustainability while ultimately improving patient care. Successful adoption of TLA will require strategic planning, interdisciplinary collaboration, and alignment with emerging healthcare needs. In this review, we emphasize that overcoming these challenges through innovation and robust management is essential for ensuring that TLA continues to play a vital role in modern healthcare systems.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"472-483"},"PeriodicalIF":3.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12370808/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794543","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 : 2025-09-01Epub Date: 2025-03-17DOI: 10.3343/alm.2024.0558
Marsha S Santoso, Eggi Arguni, Bunga Rana, Mercy E Adiniko, Dionisius Denis, Endah Supriyati, Citra Indriani, Leily Trianty, Riris Andono Ahmad, Rintis Noviyanti, R Tedjo Sasmono
Background: : Dengue is a systemic, viral, mosquito-borne infection that continues to be a major public health issue in endemic regions in tropical and subtropical climates. Accurate tests for rapid diagnosis in point-of-care settings are important to reduce the fatality rates of severe dengue. We evaluated the diagnostic accuracy of the Standard M10 DENV 1-4 system (SD Biosensor, Gyeonggi, Korea), which is a cartridge-based, automated system that integrates nucleic acid extraction, reverse transcription-PCR (RT-PCR) amplification, and detection of dengue virus (DENV) serotypes.
Methods: : This was a retrospective diagnostic evaluation study. The index test, Standard M10 DENV 1-4, was evaluated using 320 dengue-positive and 279 dengue-negative archived samples. The reference tests were a combination of Centers for Disease Control and Prevention (CDC) DENV 1-4 real-time RT-PCR, dengue NS1 antigen and IgM antibody detection, and DENV whole-genome sequencing.
Results: : The overall sensitivity and specificity of Standard M10 DENV 1-4 were 94% and 100%, respectively. By serotype, the highest sensitivity was 100% for DENV-1, and the lowest was 82% for DENV-4. The overall between the CDC RT-PCR dengue serotyping method and the Standard M10 DENV 1-4 was 95%. Standard M10 DENV 1-4 RT-PCR had comparable sensitivity and specificity to CDC DENV RT-PCR.
Conclusions: : Based on its commensurate performance to an established RT-PCR method combined with additional benefits of convenient storage and transport, easy use, and rapid processing, the Standard M10 DENV 1-4 system has potential for DENV detection and serotyping in point-of-care settings.
{"title":"Sensitivity and Specificity of an All-in-one Cartridge-based Dengue Real-time Reverse Transcription-PCR for Point-of-care Detection and Serotyping of Dengue Virus in Samples from Indonesian Patients.","authors":"Marsha S Santoso, Eggi Arguni, Bunga Rana, Mercy E Adiniko, Dionisius Denis, Endah Supriyati, Citra Indriani, Leily Trianty, Riris Andono Ahmad, Rintis Noviyanti, R Tedjo Sasmono","doi":"10.3343/alm.2024.0558","DOIUrl":"10.3343/alm.2024.0558","url":null,"abstract":"<p><strong>Background: </strong>: Dengue is a systemic, viral, mosquito-borne infection that continues to be a major public health issue in endemic regions in tropical and subtropical climates. Accurate tests for rapid diagnosis in point-of-care settings are important to reduce the fatality rates of severe dengue. We evaluated the diagnostic accuracy of the Standard M10 DENV 1-4 system (SD Biosensor, Gyeonggi, Korea), which is a cartridge-based, automated system that integrates nucleic acid extraction, reverse transcription-PCR (RT-PCR) amplification, and detection of dengue virus (DENV) serotypes.</p><p><strong>Methods: </strong>: This was a retrospective diagnostic evaluation study. The index test, Standard M10 DENV 1-4, was evaluated using 320 dengue-positive and 279 dengue-negative archived samples. The reference tests were a combination of Centers for Disease Control and Prevention (CDC) DENV 1-4 real-time RT-PCR, dengue NS1 antigen and IgM antibody detection, and DENV whole-genome sequencing.</p><p><strong>Results: </strong>: The overall sensitivity and specificity of Standard M10 DENV 1-4 were 94% and 100%, respectively. By serotype, the highest sensitivity was 100% for DENV-1, and the lowest was 82% for DENV-4. The overall between the CDC RT-PCR dengue serotyping method and the Standard M10 DENV 1-4 was 95%. Standard M10 DENV 1-4 RT-PCR had comparable sensitivity and specificity to CDC DENV RT-PCR.</p><p><strong>Conclusions: </strong>: Based on its commensurate performance to an established RT-PCR method combined with additional benefits of convenient storage and transport, easy use, and rapid processing, the Standard M10 DENV 1-4 system has potential for DENV detection and serotyping in point-of-care settings.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"503-508"},"PeriodicalIF":3.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12370802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143646966","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}
Jinyeong Kim,Eunhee Han,Jieun Kim,Young Jin Kim,Mi Hyun Bae
{"title":"Misidentification of Human Coronavirus HKU1 as OC43 by the Seegene Allplex Respiratory Panel Real-time PCR Assay.","authors":"Jinyeong Kim,Eunhee Han,Jieun Kim,Young Jin Kim,Mi Hyun Bae","doi":"10.3343/alm.2024.0637","DOIUrl":"https://doi.org/10.3343/alm.2024.0637","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"18 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144825086","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}
Yeseul Kim,Jee-Soo Lee,Boram Kim,Man Jin Kim,Sung Im Cho,Seung Won Chae,Ho Seob Shin,Hoyeon Lee,Ji Yeon Kim,Moon-Woo Seong
BackgroundCopy number variations (CNVs) play an important role in human genetic disorders. Detection of exon-level CNVs is crucial for accurate clinical diagnosis. The CytoScan XON Array, a high-resolution microarray, was recently developed to detect exonic CNVs of various genes.MethodsWe evaluated the clinical performance of the CytoScan XON Array using 59 patient samples with previously identified CNVs, confirmed via methods including multiple ligation-dependent probe amplification (MLPA), gene-dose PCR, and mRNA assay. Concordance between CytoScan XON and orthogonal methods was evaluated in target regions, and diagnostic utility was compared with that of genome sequencing (GS)-based CNV calling tools through analysis of false-positive CNVs in non-target genomic regions.ResultsFor target regions, the CytoScan XON Array achieved concordance rates of 89.8% and 92.5% at the exon and gene levels, respectively, for all CNV calls. Concordance was higher for multi-exon CNVs (100%) than that for single-exon CNVs (82.6%, P =0.03). For non-target regions, false-positive CNV calls were reduced to fewer than 0.01 per gene per person through filtering strategies. The array exhibited false-positive detection rates within dosage-sensitive genes comparable with those of GS-based tools.ConclusionsThe CytoScan XON Array, a reliable tool for detecting exon-level CNVs in target regions, can serve as a complementary approach to GS-based CNV calling tools for genome-wide CNV screening with high resolution. However, its performance for single-exon CNVs requires further optimization. Cross-validation with GS-based CNV calling tools is recommended to improve diagnostic accuracy.
拷贝数变异（CNVs）在人类遗传疾病中起着重要作用。检测外显子水平的CNVs对于准确的临床诊断至关重要。CytoScan XON阵列是一种高分辨率的微阵列，最近被开发用于检测各种基因的外显子CNVs。方法使用59例已鉴定出CNVs的患者样本，通过多重连接依赖探针扩增（MLPA）、基因剂量PCR和mRNA测定等方法进行验证，评估CytoScan XON Array的临床性能。在目标区域评估了CytoScan XON和正交方法之间的一致性，并通过分析非目标基因组区域的假阳性CNV，比较了基于基因组测序（GS）的CNV调用工具的诊断效用。结果对于目标区域，CytoScan XON阵列在所有CNV呼叫的外显子和基因水平上分别获得了89.8%和92.5%的一致性。多外显子CNVs的一致性（100%）高于单外显子CNVs （82.6%, P =0.03）。对于非目标区域，通过过滤策略，假阳性CNV呼叫减少到每个基因低于0.01。该阵列在剂量敏感基因内的假阳性检出率与基于gs的工具相当。结论CytoScan XON Array是检测靶区外显子水平CNV的可靠工具，可作为基于gs的CNV调用工具的补充方法，用于高分辨率的全基因组CNV筛选。然而，它在单外显子CNVs中的性能需要进一步优化。建议使用基于gs的CNV调用工具进行交叉验证，以提高诊断准确性。
{"title":"High-resolution Chromosomal Microarray with Diagnostic Potential for Detecting Exon-level Copy Number Variations Using Targeted and Non-targeted Approaches.","authors":"Yeseul Kim,Jee-Soo Lee,Boram Kim,Man Jin Kim,Sung Im Cho,Seung Won Chae,Ho Seob Shin,Hoyeon Lee,Ji Yeon Kim,Moon-Woo Seong","doi":"10.3343/alm.2025.0123","DOIUrl":"https://doi.org/10.3343/alm.2025.0123","url":null,"abstract":"BackgroundCopy number variations (CNVs) play an important role in human genetic disorders. Detection of exon-level CNVs is crucial for accurate clinical diagnosis. The CytoScan XON Array, a high-resolution microarray, was recently developed to detect exonic CNVs of various genes.MethodsWe evaluated the clinical performance of the CytoScan XON Array using 59 patient samples with previously identified CNVs, confirmed via methods including multiple ligation-dependent probe amplification (MLPA), gene-dose PCR, and mRNA assay. Concordance between CytoScan XON and orthogonal methods was evaluated in target regions, and diagnostic utility was compared with that of genome sequencing (GS)-based CNV calling tools through analysis of false-positive CNVs in non-target genomic regions.ResultsFor target regions, the CytoScan XON Array achieved concordance rates of 89.8% and 92.5% at the exon and gene levels, respectively, for all CNV calls. Concordance was higher for multi-exon CNVs (100%) than that for single-exon CNVs (82.6%, P =0.03). For non-target regions, false-positive CNV calls were reduced to fewer than 0.01 per gene per person through filtering strategies. The array exhibited false-positive detection rates within dosage-sensitive genes comparable with those of GS-based tools.ConclusionsThe CytoScan XON Array, a reliable tool for detecting exon-level CNVs in target regions, can serve as a complementary approach to GS-based CNV calling tools for genome-wide CNV screening with high resolution. However, its performance for single-exon CNVs requires further optimization. Cross-validation with GS-based CNV calling tools is recommended to improve diagnostic accuracy.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"13 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144737391","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}
Interferon-gamma release assays (IGRAs) are widely used to identify latent tuberculosis infection (LTBI); however, inherent test variability affects their diagnostic interpretation. We evaluated false-positive and false-negative rates, as well as conversion and reversion rates across CVs of 20%, 40%, 60%, 80%, and 100%, using statistical modeling. At a diagnostic cutoff of 0.35 IU/mL, false-negative rates increased from 1.61% to 33.41% with increasing CVs, whereas false-positive rates ranged from 0.00% to 15.87% within the 0.20-0.70 IU/mL borderline range. Expanding the borderline to 0.20-1.00 IU/mL reduced false-positive rates to a maximum of 3.16%, without affecting false-negative rates. Within the 0.20-0.70 IU/mL borderline zone, correct reversion and false conversion rates at 0.20 and 0.35 IU/mL ranged from 0.01% to 25.00% and 0.00% to 24.20%, respectively. At 0.35, 0.70, and 1.00 IU/mL, correct conversion and false reversion rates ranged from 0.05% to 24.20% and 0.00% to 25.00%, respectively. These results highlight the importance of adopting borderline zones in IGRA interpretation to reduce misclassification, although variability from manufacturing, pre-analytical processing, and analytical procedures remains a significant challenge. Reducing such variability through improved production consistency, standardized sample handling, and automated analysis platforms is essential to enhance the diagnostic reliability of IGRAs for LTBI.
{"title":"Effect of Variability on Interferon-Gamma Release Assay Performance: A Quantitative Analysis.","authors":"Won-Ki Min","doi":"10.3343/alm.2025.0066","DOIUrl":"https://doi.org/10.3343/alm.2025.0066","url":null,"abstract":"Interferon-gamma release assays (IGRAs) are widely used to identify latent tuberculosis infection (LTBI); however, inherent test variability affects their diagnostic interpretation. We evaluated false-positive and false-negative rates, as well as conversion and reversion rates across CVs of 20%, 40%, 60%, 80%, and 100%, using statistical modeling. At a diagnostic cutoff of 0.35 IU/mL, false-negative rates increased from 1.61% to 33.41% with increasing CVs, whereas false-positive rates ranged from 0.00% to 15.87% within the 0.20-0.70 IU/mL borderline range. Expanding the borderline to 0.20-1.00 IU/mL reduced false-positive rates to a maximum of 3.16%, without affecting false-negative rates. Within the 0.20-0.70 IU/mL borderline zone, correct reversion and false conversion rates at 0.20 and 0.35 IU/mL ranged from 0.01% to 25.00% and 0.00% to 24.20%, respectively. At 0.35, 0.70, and 1.00 IU/mL, correct conversion and false reversion rates ranged from 0.05% to 24.20% and 0.00% to 25.00%, respectively. These results highlight the importance of adopting borderline zones in IGRA interpretation to reduce misclassification, although variability from manufacturing, pre-analytical processing, and analytical procedures remains a significant challenge. Reducing such variability through improved production consistency, standardized sample handling, and automated analysis platforms is essential to enhance the diagnostic reliability of IGRAs for LTBI.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"14 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693366","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}
BackgroundCancer cell line-derived feeder cells enhance natural killer (NK) cell expansion; however, concerns regarding viable residual feeder cells in the final product limit their use. Evidence supporting the safety of NK-sensitive K562-based feeders, even when irradiated, is scarce. We optimized an NK cell expansion protocol using genetically engineered K562-mbIL-18/-21 (GE-K562) feeder cells and clinical-grade media and confirmed the absence of residual feeder cells.MethodsNK cell expansion efficiency was compared between feeder-free and feeder-based systems using CTS NK-Xpander Medium. To achieve optimal NK expansion, various peripheral blood mononuclear cell (PBMC)-to-feeder ratios and re-stimulation frequencies were tested over 21 days. Flow cytometry and BCR::ABL1 quantitative reverse transcription PCR (RT-qPCR) were used to confirm the absence of feeder cells in the final NK cell product.ResultsFeeder-based systems showed superior NK cell fold expansion compared with that of feeder-free systems. Among feeder-based conditions, NK cells expanded 5,224-fold at a 2:1 PBMC-to-feeder ratio after 3 weeks, relative to 1,450-fold at a 6:1 ratio (P <0.05). Re-stimulation on days 7 and 14 further increased expansion up to 261,457-fold. Irradiated feeder cells showed no proliferation and were eliminated within 3-6 days. On day 21, flow cytometry and BCR::ABL1 RT-qPCR results confirmed the absence of residual feeder cells.ConclusionsOur optimized NK cell expansion protocol using irradiated GE-K562 feeder cells and clinical-grade media offers a safe and scalable approach to generating large numbers of NK cells, supporting its potential use in clinical immunotherapy applications.
肿瘤细胞系来源的饲养细胞增强自然杀伤细胞（NK）的扩增；然而，对最终产品中残留的饲养细胞的担忧限制了它们的使用。支持对nk敏感的基于k562的喂食器的安全性的证据，即使经过辐照，也很少。我们使用基因工程K562-mbIL-18/-21 （GE-K562）饲养细胞和临床级培养基优化了NK细胞扩增方案，并证实没有残留的饲养细胞。方法采用CTS nk - expander培养基，比较无投料系统和有投料系统的snk细胞扩增效率。为了达到最佳NK扩增，在21天内测试了不同的外周血单核细胞（PBMC）与饲料的比例和再刺激频率。用流式细胞术和BCR::ABL1定量反转录PCR （RT-qPCR）证实最终NK细胞产物中不存在饲养细胞。结果加料系统的NK细胞折叠扩增率高于无加料系统。在以饲料为基础的条件下，在2:1的pbmc与饲料比例下，NK细胞在3周后扩增5,224倍，而在6:1的比例下扩增1,450倍（P <0.05）。第7天和第14天的再次刺激进一步增加了膨胀，达到261,457倍。辐照后的饲养细胞无增殖，3-6天内消失。第21天，流式细胞术和BCR::ABL1 RT-qPCR结果证实没有残留的饲养细胞。结论采用辐照的GE-K562饲养细胞和临床级培养基进行NK细胞扩增，是一种安全、可扩展的大量NK细胞扩增方法，支持其在临床免疫治疗中的潜在应用。
{"title":"Optimization of Natural Killer Cell Expansion with K562-mbIL-18/-21 Feeder Cells and Assurance of Feeder Cell-free Products.","authors":"Hantae Jo,Yujung Jo,Seung Kwon Koh,Jinho Kim,SoonHo Kweon,Jeehun Park,Hyun-Young Kim,Duck Cho,Mijeong Lee","doi":"10.3343/alm.2025.0168","DOIUrl":"https://doi.org/10.3343/alm.2025.0168","url":null,"abstract":"BackgroundCancer cell line-derived feeder cells enhance natural killer (NK) cell expansion; however, concerns regarding viable residual feeder cells in the final product limit their use. Evidence supporting the safety of NK-sensitive K562-based feeders, even when irradiated, is scarce. We optimized an NK cell expansion protocol using genetically engineered K562-mbIL-18/-21 (GE-K562) feeder cells and clinical-grade media and confirmed the absence of residual feeder cells.MethodsNK cell expansion efficiency was compared between feeder-free and feeder-based systems using CTS NK-Xpander Medium. To achieve optimal NK expansion, various peripheral blood mononuclear cell (PBMC)-to-feeder ratios and re-stimulation frequencies were tested over 21 days. Flow cytometry and BCR::ABL1 quantitative reverse transcription PCR (RT-qPCR) were used to confirm the absence of feeder cells in the final NK cell product.ResultsFeeder-based systems showed superior NK cell fold expansion compared with that of feeder-free systems. Among feeder-based conditions, NK cells expanded 5,224-fold at a 2:1 PBMC-to-feeder ratio after 3 weeks, relative to 1,450-fold at a 6:1 ratio (P <0.05). Re-stimulation on days 7 and 14 further increased expansion up to 261,457-fold. Irradiated feeder cells showed no proliferation and were eliminated within 3-6 days. On day 21, flow cytometry and BCR::ABL1 RT-qPCR results confirmed the absence of residual feeder cells.ConclusionsOur optimized NK cell expansion protocol using irradiated GE-K562 feeder cells and clinical-grade media offers a safe and scalable approach to generating large numbers of NK cells, supporting its potential use in clinical immunotherapy applications.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"32 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693310","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}
In Young Yoo,Sungjin Jo,Joo An Kwon,Jay Ho Han,Hae Kyung Lee,Yeon-Joon Park
BackgroundVarious molecular methods are used to rapidly detect gastrointestinal pathogens, highlighting the importance of understanding the performance of the associated kits in detail. We comprehensively assessed the performance of Kogene PowerChek multiplex real-time PCR kits (PowerChek Bacterial/Viral Kits) with the FilmArray GI Panel.MethodsResidual stool specimens (N=246), initially tested utilizing the FilmArray GI Panel (May 2023-Jan 2024), were reanalyzed using PowerChek Bacterial/Viral Kits. Discrepancies were resolved by performing additional molecular assays and reviewing culture results when available. True positives (TPs)/true negatives were defined by concordant results in at least two assays. We determined cycle threshold (Ct)/crossing point (Cp) distributions between the TP and false positive (FP) groups and analyzed melting curves for the FilmArray GI Panel FPs.ResultsThe positive-percent agreement (PPA) of the PowerChek Bacterial/Viral Kits was 50-100%, with lower values for Salmonella spp., rotavirus, and astrovirus, whereas the FilmArray GI Panel showed 100% PPA across all targets. Both platforms demonstrated >99% negative-percent agreement, except for enteropathogenic Escherichia coli (EPEC) and adenovirus (PowerChek Bacterial/Viral Kits) or EPEC, enteroaggregative E. coli, norovirus, and Salmonella spp. (FilmArray GI Panel). The FPs showed higher Ct/Cp values with both kits, and these values were significantly higher for adenovirus (PowerChek Viral Kit), EPEC, and norovirus (FilmArray GI Panel). Melting curve analysis of four norovirus FPs (FilmArray GI Panel) revealed atypical patterns in three cases.ConclusionsThe FilmArray GI Panel demonstrated higher sensitivity than the PowerChek Kits. For norovirus, melting curve analysis will help avoid FPs.
各种分子方法用于快速检测胃肠道病原体，强调了详细了解相关试剂盒性能的重要性。我们使用FilmArray GI Panel综合评估了Kogene PowerChek多重实时PCR试剂盒（PowerChek细菌/病毒试剂盒）的性能。方法使用FilmArray GI Panel（2023年5月- 2024年1月）进行初步检测的残余粪便标本（N=246），使用PowerChek细菌/病毒试剂盒重新分析。差异通过进行额外的分子分析和检查培养结果来解决。真阳性(TPs)/真阴性由至少两次试验的一致结果定义。我们确定了TP组和假阳性组之间的循环阈值(Ct)/交叉点（Cp）分布，并分析了FilmArray GI Panel FPs的熔化曲线。结果powercheck细菌/病毒试剂盒的阳性率（PPA）为50-100%，对沙门氏菌、轮状病毒和星状病毒的阳性率较低，而FilmArray GI Panel对所有靶标的阳性率为100%。除了肠致病性大肠杆菌（EPEC）和腺病毒（powercheck细菌/病毒试剂盒）或EPEC、肠聚集性大肠杆菌、诺如病毒和沙门氏菌（FilmArray GI Panel）外，这两个平台均显示出99%阴性的一致性。两种试剂盒的FPs均显示较高的Ct/Cp值，并且腺病毒（powercheck病毒试剂盒）、EPEC和诺如病毒（FilmArray GI Panel）的这些值显著较高。4例诺如病毒FPs的熔化曲线分析（FilmArray GI Panel）显示3例不典型。结论FilmArray GI Panel比PowerChek Kits具有更高的灵敏度。对于诺如病毒，熔化曲线分析有助于避免FPs。
{"title":"Kogene PowerChek Multiplex Real-time PCR Kits Versus the BioFire FilmArray Gastrointestinal Panel: Roles of Crossing Point Values and Melting Curves in Interpreting the FilmArray Gastrointestinal Panel.","authors":"In Young Yoo,Sungjin Jo,Joo An Kwon,Jay Ho Han,Hae Kyung Lee,Yeon-Joon Park","doi":"10.3343/alm.2025.0047","DOIUrl":"https://doi.org/10.3343/alm.2025.0047","url":null,"abstract":"BackgroundVarious molecular methods are used to rapidly detect gastrointestinal pathogens, highlighting the importance of understanding the performance of the associated kits in detail. We comprehensively assessed the performance of Kogene PowerChek multiplex real-time PCR kits (PowerChek Bacterial/Viral Kits) with the FilmArray GI Panel.MethodsResidual stool specimens (N=246), initially tested utilizing the FilmArray GI Panel (May 2023-Jan 2024), were reanalyzed using PowerChek Bacterial/Viral Kits. Discrepancies were resolved by performing additional molecular assays and reviewing culture results when available. True positives (TPs)/true negatives were defined by concordant results in at least two assays. We determined cycle threshold (Ct)/crossing point (Cp) distributions between the TP and false positive (FP) groups and analyzed melting curves for the FilmArray GI Panel FPs.ResultsThe positive-percent agreement (PPA) of the PowerChek Bacterial/Viral Kits was 50-100%, with lower values for Salmonella spp., rotavirus, and astrovirus, whereas the FilmArray GI Panel showed 100% PPA across all targets. Both platforms demonstrated >99% negative-percent agreement, except for enteropathogenic Escherichia coli (EPEC) and adenovirus (PowerChek Bacterial/Viral Kits) or EPEC, enteroaggregative E. coli, norovirus, and Salmonella spp. (FilmArray GI Panel). The FPs showed higher Ct/Cp values with both kits, and these values were significantly higher for adenovirus (PowerChek Viral Kit), EPEC, and norovirus (FilmArray GI Panel). Melting curve analysis of four norovirus FPs (FilmArray GI Panel) revealed atypical patterns in three cases.ConclusionsThe FilmArray GI Panel demonstrated higher sensitivity than the PowerChek Kits. For norovirus, melting curve analysis will help avoid FPs.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"661 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144669338","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}
BackgroundSingle nucleotide polymorphism-based chromosomal microarray analysis (CMA) can detect regions of homozygosity (ROHs), which may be associated with medical conditions; however, limited ROH data, especially in East Asians, complicates clinical interpretations. We characterized ROH distributions and frequencies in a Korean population using CMA, highlighting clinically relevant findings, including suspected uniparental disomy (UPD), using standardized criteria.MethodsWe analyzed ROHs in 1,731 individuals who underwent postnatal CMA at a Korean medical center. ROHs ≥ 3 Mb long were detected using the CytoScan Dx platform and Chromosome Analysis Suite Dx. Suspected UPD and consanguinity were assessed per the American College of Medical Genetics and Genomics technical standards.ResultsWe identified 3,962 ROHs, with 76.7% of patients carrying at least one. Common "hotspot" regions included 3p21.31p21.1 (20.3%), 11p11.2 (18.2%), 1q21.1q21.3 (17.7%), and 1p33p32.3 (12.0%). Almost all ROHs observed in >1% of patients had a median size of <5 Mb. ROH frequencies correlated negatively with chromosomal recombination rates and positively with gene densities. Additionally, 1.2% (N = 21) of patients exhibited ROH patterns suggestive of UPD or consanguinity (13 suspected UPDs on imprinted chromosomes, 6 on non-imprinted chromosomes, and 2 consanguinities); 8 of 13 patients with suspected UPD were diagnosed as having imprinting disorders, with no pathogenic copy number variations detected.ConclusionsOur population-specific ROH data for Koreans improve clinical interpretations by minimizing the risk of overinterpreting benign variants and highlight the value of standardized criteria for reliably detecting UPD and consanguinity and integrating ROH analysis into routine CMA interpretations.
{"title":"Regions of Homozygosity Identified with a Chromosomal Microarray in a Korean Population: Distribution, Frequency, and Clinical Interpretation.","authors":"Jaeryuk Kim,Sunghee Min,Chang Ahn Seol,Eul-Ju Seo","doi":"10.3343/alm.2025.0021","DOIUrl":"https://doi.org/10.3343/alm.2025.0021","url":null,"abstract":"BackgroundSingle nucleotide polymorphism-based chromosomal microarray analysis (CMA) can detect regions of homozygosity (ROHs), which may be associated with medical conditions; however, limited ROH data, especially in East Asians, complicates clinical interpretations. We characterized ROH distributions and frequencies in a Korean population using CMA, highlighting clinically relevant findings, including suspected uniparental disomy (UPD), using standardized criteria.MethodsWe analyzed ROHs in 1,731 individuals who underwent postnatal CMA at a Korean medical center. ROHs ≥ 3 Mb long were detected using the CytoScan Dx platform and Chromosome Analysis Suite Dx. Suspected UPD and consanguinity were assessed per the American College of Medical Genetics and Genomics technical standards.ResultsWe identified 3,962 ROHs, with 76.7% of patients carrying at least one. Common \"hotspot\" regions included 3p21.31p21.1 (20.3%), 11p11.2 (18.2%), 1q21.1q21.3 (17.7%), and 1p33p32.3 (12.0%). Almost all ROHs observed in >1% of patients had a median size of <5 Mb. ROH frequencies correlated negatively with chromosomal recombination rates and positively with gene densities. Additionally, 1.2% (N = 21) of patients exhibited ROH patterns suggestive of UPD or consanguinity (13 suspected UPDs on imprinted chromosomes, 6 on non-imprinted chromosomes, and 2 consanguinities); 8 of 13 patients with suspected UPD were diagnosed as having imprinting disorders, with no pathogenic copy number variations detected.ConclusionsOur population-specific ROH data for Koreans improve clinical interpretations by minimizing the risk of overinterpreting benign variants and highlight the value of standardized criteria for reliably detecting UPD and consanguinity and integrating ROH analysis into routine CMA interpretations.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"24 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144652888","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}
BackgroundAn international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage.MethodsThe program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions.ResultsBetween 2017 and 2023, 489 analytical systems were evaluated. Average acceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the kinetic Jaffe method without compensation in 2018. Over the 7-year period, the mean absolute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%, and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0 ≤ Cr < 1.0 target value range. Since 2019, a consistent reduction in absBias% has been observed.ConclusionsThis program is a pioneering response to the absence of a global certification program for Cr assays. It offers significant advantages, including comprehensive evaluations, fee-free participation, and a robust post-certification process. Continuous participation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.
{"title":"In Vitro Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future Outlook.","authors":"Eun-Jung Cho,Joonsang Yu,Jeayeon Ryu,Jiwoo Seo,Hyunae Lee,Chan-Ik Cho,Tae-Dong Jeong,Sollip Kim,Woochang Lee,Sail Chun,Won-Ki Min","doi":"10.3343/alm.2024.0654","DOIUrl":"https://doi.org/10.3343/alm.2024.0654","url":null,"abstract":"BackgroundAn international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage.MethodsThe program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions.ResultsBetween 2017 and 2023, 489 analytical systems were evaluated. Average acceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the kinetic Jaffe method without compensation in 2018. Over the 7-year period, the mean absolute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%, and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0 ≤ Cr < 1.0 target value range. Since 2019, a consistent reduction in absBias% has been observed.ConclusionsThis program is a pioneering response to the absence of a global certification program for Cr assays. It offers significant advantages, including comprehensive evaluations, fee-free participation, and a robust post-certification process. Continuous participation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"44 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144639839","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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