{"title":"Comment on \"Ionized Magnesium Correlates With Total Blood Magnesium in Pediatric Patients Following Kidney Transplant\".","authors":"Naveen Bangia, Dennis Begos, Bogdan Milojkovic","doi":"10.3343/alm.2024.0153","DOIUrl":"10.3343/alm.2024.0153","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"598-599"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003493","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}
Young Kyu Min, Jae Kyung Kim, Kyung Sun Park, Jong-Won Kim
{"title":"Evaluation of Droplet Digital PCR for the Detection of <i>BRAF</i> V600E in Fine-Needle Aspiration Specimens of Thyroid Nodules.","authors":"Young Kyu Min, Jae Kyung Kim, Kyung Sun Park, Jong-Won Kim","doi":"10.3343/alm.2023.0405","DOIUrl":"10.3343/alm.2023.0405","url":null,"abstract":"<p><strong>Background: </strong>Droplet digital (dd)PCR is a new-generation PCR technique with high precision and sensitivity; however, the positive and negative droplets are not always effectively separated because of the \"rain\" phenomenon. We aimed to develop a practical optimization and evaluation process for the ddPCR assay and to apply it to the detection of <i>BRAF</i> V600E in fine-needle aspiration (FNA) specimens of thyroid nodules, as an example.</p><p><strong>Methods: </strong>We optimized seven ddPCR parameters that can affect \"rain.\" Analytical and clinical performance were analyzed based on histological diagnosis after thyroidectomy using a consecutive prospective series of 242 FNA specimens.</p><p><strong>Results: </strong>The annealing time and temperature, number of PCR cycles, and primer and probe concentrations were found to be more important considerations for assay optimization than the denaturation time and ramp rate. The limit of blank and 95% limit of detection were 0% and 0.027%, respectively. The sensitivity of ddPCR for histological papillary thyroid carcinoma (PTC) was 82.4% (95% confidence interval [CI], 73.6%-89.2%). The pooled sensitivity of <i>BRAF</i> V600E in FNA specimens for histological PTC was 78.6% (95% CI, 75.9%-81.2%, I<sup>2</sup>=60.6%).</p><p><strong>Conclusions: </strong>We present a practical approach for optimizing ddPCR parameters that affect the separation of positive and negative droplets to reduce rain. Our approach to optimizing ddPCR parameters can be expanded to general ddPCR assays for specific mutations in clinical laboratories. The highly sensitive ddPCR can compensate for uncertainty in cytological diagnosis by detecting low levels of <i>BRAF</i> V600E.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"553-561"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141316683","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}
Shinae Yu, Byung Ryul Jeon, Changseung Liu, Dokyun Kim, Hae-Il Park, Hyung Doo Park, Jeong Hwan Shin, Jun Hyung Lee, Qute Choi, Sollip Kim, Yeo Min Yun, Eun-Jung Cho
{"title":"Laboratory Preparation for Digital Medicine in Healthcare 4.0: An Investigation Into the Awareness and Applications of Big Data and Artificial Intelligence.","authors":"Shinae Yu, Byung Ryul Jeon, Changseung Liu, Dokyun Kim, Hae-Il Park, Hyung Doo Park, Jeong Hwan Shin, Jun Hyung Lee, Qute Choi, Sollip Kim, Yeo Min Yun, Eun-Jung Cho","doi":"10.3343/alm.2024.0111","DOIUrl":"10.3343/alm.2024.0111","url":null,"abstract":"<p><strong>Background: </strong>Healthcare 4.0. refers to the integration of advanced technologies, such as artificial intelligence (AI) and big data analysis, into the healthcare sector. Recognizing the impact of Healthcare 4.0 technologies in laboratory medicine (LM), we seek to assess the overall awareness and implementation of Healthcare 4.0 among members of the Korean Society for Laboratory Medicine (KSLM).</p><p><strong>Methods: </strong>A web-based survey was conducted using an anonymous questionnaire. The survey comprised 36 questions covering demographic information (seven questions), big data (10 questions), and AI (19 questions).</p><p><strong>Results: </strong>In total, 182 (17.9%) of 1,017 KSLM members participated in the survey. Thirty-two percent of respondents considered AI to be the most important technology in LM in the era of Healthcare 4.0, closely followed by 31% who favored big data. Approximately 80% of respondents were familiar with big data but had not conducted research using it, and 71% were willing to participate in future big data research conducted by the KSLM. Respondents viewed AI as the most valuable tool in molecular genetics within various divisions. More than half of the respondents were open to the notion of using AI as assistance rather than a complete replacement for their roles.</p><p><strong>Conclusions: </strong>This survey highlighted KSLM members' awareness of the potential applications and implications of big data and AI. We emphasize the complexity of AI integration in healthcare, citing technical and ethical challenges leading to diverse opinions on its impact on employment and training. This highlights the need for a holistic approach to adopting new technologies.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"562-571"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141475829","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":"Limited Contribution of Creatine Kinase-Myocardial Band Alongside High-Sensitivity Cardiac Troponin in Diagnosing Acute Myocardial Infarction in an Emergency Department.","authors":"Hyeyoung Lee, Hyunhye Kang, Hyojin Chae, Eun-Jee Oh","doi":"10.3343/alm.2024.0083","DOIUrl":"10.3343/alm.2024.0083","url":null,"abstract":"<p><p>Cardiac biomarkers, especially high-sensitivity cardiac troponin C or I (hs-cTnC or hs-cTnI, respectively), are vital for diagnosing acute myocardial infarction (AMI). Despite the specificity of hs-cTn as a biomarker, the creatine kinase-myocardial band (CK-MB) is commonly used alongside hs-cTn in emergency departments (EDs). We analyzed 23,771 simultaneous hs-cTn (hs-cTnT or hs-cTnI) and CK-MB requests for 17,185 patients in tertiary hospital ED in 2022. The objective of this study was to assess their practical value in diagnosing AMI in real-world settings. Among all 17,185 patients tested, 98.0% underwent hs-cTnT and CK-MB tests, and substantially fewer underwent hs-cTnI testing. We observed concordance between the initial hs-cTn and CK-MB results in 71.3% of patients. Of 131 AMI cases, 57 were positive for both biomarkers, 63 for hs-cTn only, and none for CK-MB alone. CK-MB positivity was often found in the absence of AMI. Discrepancies between the hs-cTnT and hs-cTnI results occurred in 30.0% of patients. Indiscriminate CK-MB testing for diagnosing AMI in EDs should be reconsidered. Efficient use of CK-MB is important for reducing costs and ensuring optimal patient care.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"586-590"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141442033","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":"Aberrant Splicing in <i>PKD2</i> in a Family of Korean Patients With Autosomal Dominant Polycystic Kidney Disease.","authors":"Soo-Young Yoon, Jin Sug Kim, Kyung Sun Park","doi":"10.3343/alm.2024.0221","DOIUrl":"10.3343/alm.2024.0221","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"621-624"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016229","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}
Sollip Kim, Tae-Dong Jeong, Kyunghoon Lee, Jae-Woo Chung, Eun-Jung Cho, Seunghoo Lee, Sail Chun, Junghan Song, Won-Ki Min
{"title":"Quantitative Evaluation of the Real-World Harmonization Status of Laboratory Test Items Using External Quality Assessment Data.","authors":"Sollip Kim, Tae-Dong Jeong, Kyunghoon Lee, Jae-Woo Chung, Eun-Jung Cho, Seunghoo Lee, Sail Chun, Junghan Song, Won-Ki Min","doi":"10.3343/alm.2024.0082","DOIUrl":"10.3343/alm.2024.0082","url":null,"abstract":"<p><strong>Background: </strong>In recent decades, the analytical quality of clinical laboratory results has substantially increased because of collaborative efforts. To effectively utilize laboratory results in applications, such as machine learning through big data, understanding the level of harmonization for each test would be beneficial. We aimed to develop a quantitative harmonization index that reflects the harmonization status of real-world laboratory tests.</p><p><strong>Methods: </strong>We collected 2021-2022 external quality assessment (EQA) results for eight tests (HbA1c, creatinine, total cholesterol, HDL-cholesterol, triglyceride, alpha-fetoprotein [AFP], carcinoembryonic antigen [CEA], and prostate-specific antigen [PSA]). This EQA was conducted by the Korean Association of External Quality Assessment Service, using commutable materials. The total analytical error of each test was determined according to the bias% and CV% within peer groups. The values were divided by the total allowable error from biological variation (minimum, desirable, and optimal) to establish a real-world harmonization index (RWHI) at each level (minimum, desirable, and optimal). Good harmonization was arbitrarily defined as an RWHI value ≤ 1 for the three levels.</p><p><strong>Results: </strong>Total cholesterol, triglyceride, and CEA had an optimal RWHI of ≤ 1, indicating an optimal harmonization level. Tests with a desirable harmonization level included HDL-cholesterol, AFP, and PSA. Creatinine had a minimum harmonization level, and HbA1c did not reach the minimum harmonization level.</p><p><strong>Conclusions: </strong>We developed a quantitative RWHI using regional EQA data. This index may help reflect the actual harmonization level of laboratory tests in the field.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"529-536"},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141449472","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}
Takho Kang, Ryoojung Choi, Dong-Sik Kim, Duck Cho, Dae Won Kim
{"title":"A Case of Bidirectional ABO- and RhD-Incompatible Liver Transplantation in a Mongolian Patient With Asian-type DEL.","authors":"Takho Kang, Ryoojung Choi, Dong-Sik Kim, Duck Cho, Dae Won Kim","doi":"10.3343/alm.2024.0399","DOIUrl":"https://doi.org/10.3343/alm.2024.0399","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543374","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}
Bongyoung Kim, Myungsook Kim, Kyungwon Lee, Yangsoon Lee
{"title":"Clinical Outcomes and Molecular Characteristics of <i>Bacteroides fragilis</i> Infections.","authors":"Bongyoung Kim, Myungsook Kim, Kyungwon Lee, Yangsoon Lee","doi":"10.3343/alm.2024.0369","DOIUrl":"https://doi.org/10.3343/alm.2024.0369","url":null,"abstract":"<p><p><i>Bacteroides fragilis</i> is the most common opportunistic anaerobic pathogen. In the absence of appropriate antimicrobial therapy, mortality rates associated with <i>B. fragilis</i> group infections can reach as high as 50%. Therefore, we aimed to elucidate the clinical characteristics and outcomes of <i>B. fragilis</i> infections and the molecular genetic characteristics of <i>B. fragilis</i> isolates. Forty <i>B. fragilis</i> clinical isolates were collected at Hanyang University Hospital between January 2022 and December 2023. Antimicrobial susceptibility was tested using the agar dilution method. Whole-genome sequencing was conducted using the Illumina platform (Illumina, San Diego, CA, USA). Various multilocus sequence types of <i>B. fragilis</i> were identified, including ST149 (N=4), ST11 (N=4), ST1 (N=3), ST21 (N=2), and ST157 (N=1). The insertion sequence (IS) IS<i>1187</i>, located upstream of <i>cfiA</i>, was associated with high-level carbapenem resistance in the ST157 isolate. <i>B. fragilis</i> toxin genes (bft ) were identified in 30% of isolates. The most common comorbidities were diabetes mellitus (26.5%) and non-metastatic cancer (23.5%). Five patients (14.7%) died within 30 days, and two (5.9%) deaths were directly attributable to <i>B. fragilis</i> infection. The emergence of high-level MIC carbapenem-resistant <i>B. fragilis</i> ST157 has led to caution in the presence of <i>B. fragilis</i> infections.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Laboratory Data as a Potential Source of Bias in Healthcare Artificial Intelligence and Machine Learning Models.","authors":"Hung S Luu","doi":"10.3343/alm.2024.0323","DOIUrl":"https://doi.org/10.3343/alm.2024.0323","url":null,"abstract":"Artificial intelligence (AI) and machine learning (ML) are anticipated to transform the practice of medicine. As one of the largest sources of digital data in healthcare, laboratory results can strongly influence AI and ML algorithms that require large sets of healthcare data for training. Embedded bias introduced into AI and ML models not only has disastrous consequences for quality of care but also may perpetuate and exacerbate health disparities. The lack of test harmonization, which is defined as the ability to produce comparable results and the same interpretation irrespective of the method or instrument platform used to produce the result, may introduce aggregation bias into algorithms with potential adverse outcomes for patients. Limited interoperability of laboratory results at the technical, syntactic, semantic, and organizational levels is a source of embedded bias that limits the accuracy and generalizability of algorithmic models. Population-specific issues, such as inadequate representation in clinical trials and inaccurate race attribution, not only affect the interpretation of laboratory results but also may perpetuate erroneous conclusions based on AI and ML models in the healthcare literature.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"2 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489735","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}