Annals of Laboratory Medicine最新文献

{"title":"Comparative Evaluation of the Effects of Serum Separator Tubes and Transport Systems on Hormone and Tumor Marker Measurements.","authors":"Hyun-Woo Lee,Hyung-Doo Park","doi":"10.3343/alm.2025.0409","DOIUrl":"https://doi.org/10.3343/alm.2025.0409","url":null,"abstract":"BackgroundControlling pre-analytical factors ensures the accuracy of hormone and tumor marker assays. We evaluated the combined effects of using different serum separator tubes (i.e., Ampulab [Soyagreentec]), Vacutainer [Becton Dickinson], and Vacuette [Greiner Bio-One]) and transport methods (i.e., the AirLab high-speed pneumatic tube system [PTS; PazKorea] and a conveyor system) on measurement results of 20 analytes.MethodsBlood was collected from 57 volunteers and equally distributed into six tubes per participant to cover all possible tube type-transport system combinations. Twenty analytes were measured using Cobas e801 (Roche Diagnostics) and UniCel DXI 800 (Beckman Coulter) analyzers. For each analyte, the same analyzer was used across all samples. To evaluate hemolysis in PTS-transported samples, hemolytic index, AST, potassium, and lactate dehydrogenase levels were measured using Cobas c702 (Roche Diagnostics). Clinically significant or important differences were defined as average percentage biases exceeding European Federation of Clinical Chemistry and Laboratory Medicine desirable and optimal bias criteria, respectively.ResultsEstradiol showed a clinically significant difference (-8.21%) in conveyor-transported Vacutainer versus Vacuette tubes and clinically important difference between Ampulab and other tubes as separator gel adsorption was different. Insulin exhibited a clinically important negative bias (-6.83%) in PTS-transported Vacuette tubes owing to insulin-degrading enzyme release from hemolyzed erythrocytes. No other analytes exhibited clinically significant or important differences. Vacuette tubes were the most susceptible to PTS-induced hemolysis, corresponding to the largest insulin bias.ConclusionsAmpulab tubes and the AirLab system performed comparably to their comparators, though caution is warranted for estradiol and insulin results.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"12 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147471564","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":"Diagnostic and Prognostic Utility of Monocyte Cell Population Data in Emergency Department Patients with Suspected Sepsis.","authors":"Hyejung Lee,Hanah Kim,Mina Hur,Gun-Hyuk Lee,Jong-Ho Yi,Hee-Won Moon,Yeo-Min Yun","doi":"10.3343/alm.2025.0714","DOIUrl":"https://doi.org/10.3343/alm.2025.0714","url":null,"abstract":"BackgroundCell population data (CPD) have been suggested as useful biomarkers for sepsis. We evaluated the diagnostic and prognostic utility of monocyte CPD parameters for sepsis diagnosis in an emergency department (ED) setting.MethodsIn 485 patients with suspected sepsis (sepsis, N=170), 14 monocyte CPD parameters were measured using a DxH 900 analyzer (Beckman Coulter). The most effective monocyte CPD parameters were selected for diagnosing sepsis and predicting 30-day mortality. Using the ROC curve analyses, the selected CPD parameters were compared with quick sequential organ failure assessment (qSOFA) (for diagnosing sepsis) and SOFA scores (for predicting 30-day mortality). The hazard ratio (HR) for 30-day mortality prediction was derived from Kaplan-Meier survival curves.ResultsSD of monocyte median angle light scatter (SD-MALS-MO) and mean monocyte conductivity (MN-C-MO) were the most effective monocyte CPD parameters. SD-MALS-MO significantly enhanced the performance of qSOFA score for sepsis diagnosis [area under the curve (AUC), 0.77 vs. 0.73; P <0.009]. MN-C-MO and SD-MALS-MO combined performed comparably to SOFA score in predicting 30-day mortality (AUC, 0.70 vs. 0.75; P =0.321) but yielded a higher HR for 30-day mortality than SOFA score (HR: 7.5 vs. 5.8, P <0.001).ConclusionsMonocyte CPD parameters offer additional value to qSOFA score for diagnos-ing sepsis, and their combination is as effective as SOFA score for predicting 30-day mor-tality in ED patients with suspected sepsis. Monocyte CPD parameters can be valuable di-agnostic and prognostic biomarkers for sepsis.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"15 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147465299","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":"Patient Data and refineR for Efficient Monitoring and Verifying Laboratory Reference Intervals: A Practical Approach.","authors":"Jorge Díaz-Garzón Marco,Daniel Prieto Arribas,Isabel Moreno-Parro,Berta Sufrate-Vergara,Rroberto Mora Corcovado,Antonio Buño Soto,Pilar Fernández-Calle","doi":"10.3343/alm.2025.0564","DOIUrl":"https://doi.org/10.3343/alm.2025.0564","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"26 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147465298","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":"Development and Evaluation of Artificial Intelligence-Based Two-Step Model for Automated Serum Quality Assessment in Clinical Laboratories.","authors":"Weixin Chen,Yuxuan Xiong,Chenxi Zhang,Zhifang Sui,Fengning Yang,Zikun Ma,Qinglin Liu,Yuexin Cui,Ran Han","doi":"10.3343/alm.2025.0509","DOIUrl":"https://doi.org/10.3343/alm.2025.0509","url":null,"abstract":"BackgroundEnhancing pre-analytical QC in clinical laboratories and providing risk alerts is crucial for ensuring accurate test results for patients whose samples are affected by hemolysis, icterus, or lipemia. We evaluated a novel, self-developed artificial intelligence (AI) approach for assessing serum quality using a two-step deep learning YOLOv5-ResNet-50 architecture model and explored its performance under real-world laboratory conditions.MethodsThe performance of the two-step model prototype integrated into a Roche Cobas c 701 module (Roche Diagnostics, Shanghai, China) for preprocessing was assessed. By combining serum index testing with manual evaluation, we established a laboratory-specific model for automated sample quality identification. A primary dataset of 21,000 serum samples was partitioned into a training set (80%) and a validation set (20%) for model development and tuning. Subsequently, a separate, independent test dataset of 21,000 samples was used to conduct the final, unbiased evaluation of the model's performance, with statistical analysis.ResultsThe AI serum model achieved recognition accuracies exceeding 97% for hemolysis and icterus and over 92% for lipemia. In human-machine comparisons, the AI model demonstrated higher consistency (72% exact agreement) than manual assessments (42%-68% exact agreement).ConclusionsThe AI-powered serum quality software demonstrated high accuracy in preanalytical serum quality assessment, offering a performance that meets or exceeds that of both automated and manual measurements. This tool can enhance laboratory efficiency and reduce the error risks associated with subjective visual evaluations.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"50 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147374088","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":"First Report of KPC-2-Producing Hafnia paralvei: Evidence of Horizontal Gene Transfer from Klebsiella pneumoniae.","authors":"Sun-Mi Cho,Myung Seo Kang,Seong Geun Hong","doi":"10.3343/alm.2025.0519","DOIUrl":"https://doi.org/10.3343/alm.2025.0519","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"21 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147329511","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":"Development and Diagnostic Validation of an Automated Rapid Testing Platform for Serum Lysophosphatidylcholine as a Sepsis Biomarker.","authors":"Hyeon Kyu Choi,Hyesoo Kim,Mi Hwa Shin,Chul Hoon Kim,Ah Young Leem,Su Hwan Lee,Kyung Soo Chung,Young Sam Kim,Hanmil Jang,John Hoon Rim,Byung Hoon Kho,Gi Hun Seoung,Wondong Kim,Jong-Baeck Lim,Moo Suk Park","doi":"10.3343/alm.2025.0302","DOIUrl":"https://doi.org/10.3343/alm.2025.0302","url":null,"abstract":"BackgroundSepsis is a life-threatening condition, requiring timely diagnosis and reliable biomarkers for effective management. Lysophosphatidylcholine (LPC) has emerged as a promising biomarker; however, conventional quantification methods, such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), are time-consuming and resourceintensive. We developed and validated an automated rapid testing platform based on enzymatic spectrophotometry for serum LPC quantification.MethodsSerum LPC was quantified using an automated rapid testing platform based on enzymatic hydrogen peroxide generation, detected colorimetrically with the chromogen DA-67. Analytical accuracy was evaluated through method comparison with ultraviolet-visible spectrophotometry (N=35 samples) and an LC-MS/MS (N=120 samples). Participants were classified into sepsis and septic shock (N=35), systemic inflammatory response syndrome (SIRS, N=10), and healthy controls (N=75). Statistical analyses included logistic regression, ROC analysis, and Kaplan-Meier survival analysis.ResultsThe automated rapid testing platform reflected LPC concentration-dependent absorbance changes and differentiated clinical groups. Serum LPC concentrations were significantly lower in patients with sepsis or septic shock than in healthy controls and patients with SIRS (all P <0.05). We observed strong concordance with LC-MS/MS data (r=0.99) and significant correlations with C-reactive protein concentrations and white blood cell counts. Low LPC concentrations were independently associated with 90-day mortality.ConclusionsOur platform enables rapid and accurate LPC measurements with minimal sample requirements, facilitating diagnosis and risk stratification and paving the way for more individualized and timely care for patients with sepsis.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"71 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147329505","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":"Age-Stratified Genetic Spectrum of Retinitis Pigmentosa in Korean Patients: Predominance of <i>RPGR</i> Variants in Early-Onset Disease.","authors":"Youn-Ji Hong, Sungsoon Hwang, Ja-Hyun Jang, Jong-Won Kim, Sang Jin Kim, Mi-Ae Jang","doi":"10.3343/alm.2025.0146","DOIUrl":"10.3343/alm.2025.0146","url":null,"abstract":"<p><strong>Background: </strong>Retinitis pigmentosa (RP) comprises a heterogeneous group of inherited retinal dystrophies. The genetic landscape of RP has been characterized; however, knowledge gaps regarding age-specific genetic variation trends in Korean patients remain. We comprehensively characterized the age-stratified genetic landscape of RP in Korean patients, with a focus on identifying novel mutational trends and clinically actionable insights.</p><p><strong>Methods: </strong>We performed targeted next-generation sequencing of 199 genes associated with RP and related disorders in a cohort of 403 unrelated patients clinically diagnosed as having RP. We analyzed the inheritance patterns, variation spectrum, and prevalence of pathogenic variants, stratifying the results by age, and conducted copy number variation (CNV) analysis.</p><p><strong>Results: </strong>A genetic diagnosis was achieved for 193 of the 403 patients (48%). The diagnostic yield was highest in patients diagnosed before 20 yrs of age (60%), with lower yields in older age groups. Although <i>USH2A</i> and <i>EYS</i>, the most common causative genes in autosomal recessive inheritance, were frequently identified, <i>RPGR</i> pathogenic variants accounted for a significantly larger proportion of genetically solved cases diagnosed before the age of 20 yrs (27%-28%) than in those with later-onset disease (9%-15%). CNVs were identified in 4% of genetically solved cases.</p><p><strong>Conclusions: </strong>The results underscore distinct, age-related genetic contributions to RP in Korean patients, with <i>RPGR</i> variants demonstrating relevance in early-onset disease, and provide diagnostic insights to improve current practices. These findings can aid in prioritizing gene therapy targets and refining screening strategies.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"200-209"},"PeriodicalIF":4.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145848733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations of Flow Cytometric Lymphocyte Subset Analysis in Korea Based on a Survey of Current Clinical Laboratory Practice.","authors":"Mikyoung Park, Hyun-Woo Choi, Jihyang Lim, Kyung-Hwa Shin, Eun-Jee Oh, Jaewoo Song, Kyeong-Hee Kim, In Hwa Jeong, Joo-Heon Park, Sang-Hyun Hwang, Eun-Suk Kang","doi":"10.3343/alm.2025.0064","DOIUrl":"10.3343/alm.2025.0064","url":null,"abstract":"<p><p>Flow cytometric lymphocyte subset analysis (FCLSA) is essential for assessing immune status across various diseases and clinical settings. We surveyed current clinical laboratory practices related to FCLSA to establish a baseline reference for future standardization in Korea. Nine university hospitals actively performing FCLSA responded to the 22-question survey, which covered seven categories of laboratory practice. These hospitals used commercial reagent antibody kits from either Beckton Dickinson Biosciences (N=4) or Beckman Coulter Diagnostics (N=5). Most hospitals performed daily instrument setup and scheduled maintenance every 2-6 months. Two levels of commercial quality control materials were routinely used each day. Sample and reagent antibody volumes varied across hospitals, even when the same reagent kit was used. Acquired cell counts ranged from 5×10³ to 5×10⁴ cells, with two hospitals adjusting counts based on the cell type analyzed. Most laboratories reported percentages and general opinions; some additionally reported white blood cell and lymphocyte counts, along with lymphocyte percentages. This is the first comprehensive survey on the clinical laboratory practice of FCLSA in Korea. Standardization of FCLSA should be accelerated to ensure reliable and reproducible results.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"220-225"},"PeriodicalIF":4.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Accuracy of Serological Tests for <i>Mycoplasma pneumoniae</i> Infections in Children with Pneumonia, Based on Symptom Onset.","authors":"Gahee Kim, Ki Wook Yun, Dayun Kang, Taek Jin Lee, Byung Wook Eun, Hyunju Lee, Yae-Jean Kim, Doo Ri Kim, Areum Shin, Hyun Mi Kang, Ye Ji Kim, Byung Ok Kwak, Younghee Lee, Ye Kyung Kim, Young June Choe, Woosuck Suh, Kyo Jin Jo, Kyung-Ran Kim, Eun Young Cho, Kyung Min Kim, Joon Kee Lee, Su Eun Park","doi":"10.3343/alm.2025.0125","DOIUrl":"10.3343/alm.2025.0125","url":null,"abstract":"<p><strong>Background: </strong><i>Mycoplasma pneumoniae</i> is a major cause of community-acquired pneumonia (CAP) in children, with a rising incidence of macrolide resistance. Early diagnosis is crucial for reducing the disease burden; however, current diagnostic tools have limitations. We evaluated the diagnostic accuracy of serological assays and their performance based on symptom onset in children with CAP.</p><p><strong>Methods: </strong>From September 2023 to September 2024, we prospectively enrolled children with CAP, classified as <i>M. pneumoniae</i> pneumonia (MPP) or non-MPP, from 16 hospitals in Korea. Serological testing included chemiluminescence immunoassay (CLIA) and ELISA for detecting IgM and IgG, along with particle agglutination (PA) for total antibody measurements. Serological responses were analyzed at different times after symptom onset (0-4, 5-9, and 10-21 days).</p><p><strong>Results: </strong>Among 472 children with CAP (362 MPP, 110 non-MPP), 138 (29.2%) underwent PA testing, and 334 (70.8%) underwent IgM testing. PA at a 1:640 cutoff showed 48.0% sensitivity and 100% specificity. CLIA and ELISA showed comparable sensitivities (69.1% vs. 69.2%) and specificities (76.9% vs. 66.7%) for IgM testing. Seropositivity increased significantly with time since symptom onset (<i>P</i> for trend<0.001), reaching 97.9% for IgM, 62.5% for IgG, and 94.7% for PA at 10-21 days.</p><p><strong>Conclusions: </strong>The time post-symptom onset significantly influenced the diagnostic utility of serological tests for pediatric MPP, which showed limited value during the early stage of illness. These findings emphasize the importance of symptom onset-based interpretation of serological test results and their utility in complementing PCR when optimizing MPP diagnosis in children.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"162-170"},"PeriodicalIF":4.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144940403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First Report of Lipoprotein X Formation in Methimazole-Induced Cholestatic Jaundice with Agranulocytosis.","authors":"Yoon E Shin, Hyun Ju Lee, Yoon Young Cho, Bo-Yeon Kim, Chan-Hee Jung, Ji-Oh Mok, Chul-Hee Kim, Yong-Wha Lee, Dughyun Choi","doi":"10.3343/alm.2025.0305","DOIUrl":"10.3343/alm.2025.0305","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"230-233"},"PeriodicalIF":4.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145931928","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}