Archives of pathology & laboratory medicine最新文献

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A Novel Eye- and Head-Tracking Interface for Digital Pathology Reduces Hand Movement and Improves Target Detection Accuracy. 一种用于数字病理学的新型眼和头跟踪接口减少了手部运动并提高了目标检测精度。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-06-12 DOI: 10.5858/arpa.2025-0628-OA
Alana Lopes, Bojana Djordjevic, Emily A Goebel, Jose A Gomez, Leah J J McDonald, Maria Florencia Mora, Joanna C Walsh, Luojun Wang, Bret Wehrli, Cady Zeman-Pocrnich, Matthew J Cecchini, Aaron D Ward
{"title":"A Novel Eye- and Head-Tracking Interface for Digital Pathology Reduces Hand Movement and Improves Target Detection Accuracy.","authors":"Alana Lopes, Bojana Djordjevic, Emily A Goebel, Jose A Gomez, Leah J J McDonald, Maria Florencia Mora, Joanna C Walsh, Luojun Wang, Bret Wehrli, Cady Zeman-Pocrnich, Matthew J Cecchini, Aaron D Ward","doi":"10.5858/arpa.2025-0628-OA","DOIUrl":"10.5858/arpa.2025-0628-OA","url":null,"abstract":"<p><strong>Context.—: </strong>The transition toward digital pathology brings ergonomic and efficiency challenges with mouse or other hand-based input devices for digital slide assessment, requiring users to move their hands frequently, raising the risk of repetitive strain injury. This work explores non-hand-based input devices for digital pathology.</p><p><strong>Objective.—: </strong>To determine the feasibility of using eye and head tracking as input devices for completing representative tasks in digital pathology, compared to the computer mouse.</p><p><strong>Design.—: </strong>Eight pathologists completed 5 representative digital pathology tasks: measuring, counting, zooming, panning, and target identification. Each task was first completed with the computer mouse as the input device, then repeated with eye and head tracking as the input devices, after a washout. Eye gaze data were collected throughout. Pathologists were asked to complete a survey on their experience.</p><p><strong>Results.—: </strong>Measurements made with eye gaze were 0.18% more accurate than those made with mouse (P = .001). Differences in point localization accuracy for measurement and counting with eye gaze were both less than 10 μm, compared to mouse (P < .001, for both). Hand movement was reduced for counting, zooming, and panning with eye and head tracking (P = .04, P = .009, and P = .04, respectively). No targets were missed with head tracking, whereas 8 targets were missed with mouse. Most pathologists favored eye tracking for counting and zooming.</p><p><strong>Conclusions.—: </strong>Eye and head tracking are feasible input devices for digital pathology and provide comparable accuracy to the computer mouse. Head tracking suggests continuous panning of the image is a superior and safer method when an exhaustive search for targets is required.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148267249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interobserver Variability Across Whole-Slide Imaging Systems. 整个幻灯片成像系统的观察者间可变性。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-06-08 DOI: 10.5858/arpa.2025-0449-OA
Benzion Samueli, Hikmat Al-Ahmadie, Marina Baine, Melissa Pulitzer, Marc Rosenblum, Emaan Alvi, Harshita Mehrotra, Elisabet Pujadas, Dan Carlucci, Kaitlyn Gelfant, Ali Manzo, Lisette Spencer, Julia Stetsyk, Jacob Dreiher, Victor E Reuter, Meera Hameed, Orly Ardon
{"title":"Interobserver Variability Across Whole-Slide Imaging Systems.","authors":"Benzion Samueli, Hikmat Al-Ahmadie, Marina Baine, Melissa Pulitzer, Marc Rosenblum, Emaan Alvi, Harshita Mehrotra, Elisabet Pujadas, Dan Carlucci, Kaitlyn Gelfant, Ali Manzo, Lisette Spencer, Julia Stetsyk, Jacob Dreiher, Victor E Reuter, Meera Hameed, Orly Ardon","doi":"10.5858/arpa.2025-0449-OA","DOIUrl":"10.5858/arpa.2025-0449-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Digital pathology whole-slide images (WSIs) must be of adequate quality for use in diagnostics and the development of artificial intelligence algorithms. Inadequate slides should be re-scanned. There is insufficient data on what qualifies as WSI adequacy.</p><p><strong>Objective.—: </strong>To report on the degree of inter-cohort agreement when evaluating WSI quality and adequacy for use in primary diagnostics.</p><p><strong>Design.—: </strong>The 60 validation slides were scanned by 3 scanners (Leica GT450, Hamamatsu NanoZoomer S360, and Huron TissueScope iQ). The resulting 180 WSIs were independently evaluated on a quality pass or fail basis by 12 observers representing 4 staff members of the following: in-house attending physicians, fellows, and imaging technicians. The Cohen's kappa was calculated overall and within each cohort, and the acceptance rate was compared between cohorts.</p><p><strong>Results.—: </strong>For almost every cohort on each scanner, the Cohen's kappa was weak (0.21-0.4) or very poor (<0.2). Based on WSI pass rates, the data yielded different scanner rankings across cohorts, with the GT450, TissueScope iQ, and NanoZoomer S360 exhibiting the highest pass rates for technicians, fellows, and attendings, respectively.</p><p><strong>Conclusions.—: </strong>There is significant interobserver and inter-cohort variability in the rating of WSIs for suitability in diagnostic pathology. Setting uniform, reproducible standards is important for patient safety, creating a uniform level of care, efficiently re-scanning subpar slides, developing artificial intelligence models on images characteristic of those used in clinical practice, and accurately representing the quality of a scanner.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13684972/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148207235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hyperspectral Imaging for Breast-Conserving Surgery Margin Assessment: A Systematic Review. 高光谱成像用于保乳手术边缘评估:系统综述。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-06-05 DOI: 10.5858/arpa.2025-0627-RA
Kalpana Kumari, Lavleen Singh, Rishikesh Pandey, Ruchi Rathore, Venkateswaran K Iyer, Sandeep R Mathur
{"title":"Hyperspectral Imaging for Breast-Conserving Surgery Margin Assessment: A Systematic Review.","authors":"Kalpana Kumari, Lavleen Singh, Rishikesh Pandey, Ruchi Rathore, Venkateswaran K Iyer, Sandeep R Mathur","doi":"10.5858/arpa.2025-0627-RA","DOIUrl":"https://doi.org/10.5858/arpa.2025-0627-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Breast-conserving surgery (BCS) offers comparable overall survival rates to mastectomy. However, 14% to 37% of cases require re-excision owing to tumor-positive margins after BCS. Hyperspectral imaging (HSI) provides rapid, real-time, thorough margin assessment, reducing the burden of re-excisions.</p><p><strong>Objective.—: </strong>To systematically review studies published up to January 2026 investigating HSI or multispectral imaging for breast cancer margin assessment.</p><p><strong>Data sources.—: </strong>Twenty-four primary studies involving HSI or multispectral imaging of fresh lumpectomy specimens or histologic slides in breast cancer were included, focusing on reporting methodology, imaging setup, machine learning models, diagnostic performance, and comparisons to standard techniques. Key data on sample types, imaging acquisition (spectral range, modality), preprocessing, algorithms (conventional classifiers and deep learning), validation methods, and diagnostic accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve [AUC]) were extracted.</p><p><strong>Conclusions.—: </strong>HSI consistently differentiated malignant from normal breast tissue across studies. In ex vivo lumpectomy specimens, HSI classifiers achieved sensitivity of 83% to 96% and specificity of 72% to 96% for margin-level detection, with AUC approximating 0.9. Machine learning ranged from linear discriminant analysis and support vector machines to convolutional neural networks and clustering algorithms, leveraging visible spectrum to near-infrared spectral range. HSI was integrated into simulated surgical workflows, imaging a lumpectomy surface within ∼10 minutes and providing automated margin maps in 3 minutes. Bulky hardware, calibration requirements, reduced spectral resolution, and regulatory approval remain major challenges to clinical adoption. No HSI devices have regulatory approval for intraoperative margin assessment in BCS. HSI enables whole-surface visualization of tumor margins. Translating HSI requires multidisciplinary efforts and prospective multisite trials.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
KMT2A Amplification in Mixed-Phenotype Acute Leukemia: Immunophenotyping, Cytogenomic Features, and Clinical Correlation. KMT2A扩增在混合表型急性白血病:免疫表型,细胞基因组特征和临床相关性。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-06-05 DOI: 10.5858/arpa.2025-0485-OA
Madhulatha Pantrangi, Paul Dylan Barone, Rebecca J Leeman-Neill, Liming Bao
{"title":"KMT2A Amplification in Mixed-Phenotype Acute Leukemia: Immunophenotyping, Cytogenomic Features, and Clinical Correlation.","authors":"Madhulatha Pantrangi, Paul Dylan Barone, Rebecca J Leeman-Neill, Liming Bao","doi":"10.5858/arpa.2025-0485-OA","DOIUrl":"https://doi.org/10.5858/arpa.2025-0485-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Mixed-phenotype acute leukemia (MPAL) is a rare form of leukemia with a typically unfavorable prognosis. While KMT2A (lysine methyltransferase 2A) rearrangements resulting in gene fusions are common in MPAL, information on KMT2A amplification is lacking.</p><p><strong>Objective.—: </strong>To determine whether KMT2A-amplified MPAL correlates with complex karyotype, TP53 (tumor protein p53) aberration, and shortened survival, aiming to refine risk stratification for better patient management.</p><p><strong>Design.—: </strong>Flow cytometry, karyotyping, fluorescence in situ hybridization, single nucleotide polymorphism (SNP) microarray, and molecular approaches were used to characterize 3 MPAL cases with KMT2A amplification and clinical correlation.</p><p><strong>Results.—: </strong>All 3 cases exhibited B-lymphoid/myeloid phenotypes and highly complex karyotypes. Our analysis showed that KMT2A amplifications were intrachromosomal, appearing as homogeneously staining regions (hsr) in 2 cases. In patients 1 and 2, the hsr was located on ring chromosome 7 and chromosome 11, respectively. Interestingly, in patient 3, amplification was found on multiple marker chromosomes. TP53 abnormalities were observed in 2 cases. Single nucleotide polymorphism (SNP) microarray analysis of 1 case revealed oscillating copy number variations on chromosome 11, suggestive of chromoanasynthesis. The amplified region included cancer-related genes KMT2A and DDX6 (DEAD-box helicase 6).</p><p><strong>Conclusions.—: </strong>Findings from our study show that KMT2A-amplified MPAL is associated with complex karyotypes, TP53 abnormalities, and an inferior outcome. Our data may help refine MPAL risk stratification.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
FL5 Through the Years: A Summary of Interpretation-Only Leukemia/Lymphoma Flow Cytometry Proficiency Testing From the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. FL5:多年来:美国病理学家诊断免疫学和流式细胞术委员会对仅限解释的白血病/淋巴瘤流式细胞术水平测试的总结。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-06-05 DOI: 10.5858/arpa.2025-0614-CP
Katherine A Devitt, Wei Cui, Giovanni Insuasti-Beltran, Christine P Bashleben, David M Dorfman
{"title":"FL5 Through the Years: A Summary of Interpretation-Only Leukemia/Lymphoma Flow Cytometry Proficiency Testing From the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee.","authors":"Katherine A Devitt, Wei Cui, Giovanni Insuasti-Beltran, Christine P Bashleben, David M Dorfman","doi":"10.5858/arpa.2025-0614-CP","DOIUrl":"https://doi.org/10.5858/arpa.2025-0614-CP","url":null,"abstract":"<p><strong>Context.—: </strong>The Diagnostic Immunology and Flow Cytometry Committee of the College of American Pathologists implemented the FL5 interpretation-only leukemia and lymphoma program in 2009 to survey laboratories for interpretative agreement of flow cytometric data.</p><p><strong>Objective.—: </strong>To report the results of the FL5 program from 2009 to 2024.</p><p><strong>Design.—: </strong>Program participants received 2 sets of paper challenges per year consisting of clinical summaries, laboratory findings, and flow cytometric data. Summary responses were provided for all participants. Supplemental questions were included in 2024.</p><p><strong>Results.—: </strong>Subscribing laboratories increased from 38 in 2009 to 368 in 2024. The 16 years of the program have seen 32 FL5 surveys and 80 challenges. Diagnostic categories included 34 B-cell cases (42.5%; 27 mature [33.75%], 7 immature [8.75%]); 23 T/NK (natural killer)-cell cases (28.75%; 16 mature [20%], 7 immature [8.75%]); 18 myeloid cases (22.5%); and 5 others (6.25%). Cases were varied, covering routine and rare entities. There were 34 high-agreement cases, most common within the mature B-lymphoproliferative disorder category (15). Supplemental question responses included 123 of 290 (42%) that performed both testing and interpretation, while 168 (58%) performed interpretation only. The majority (182 of 275; 66%) used FL5 to assess integration of all data to arrive at a specific hematopathologic diagnosis, while some (89; 32%) assessed flow cytometry-based diagnosis. Few (4; 1%) assessed discernment of antigen positivity in a defined population of interest.</p><p><strong>Conclusions.—: </strong>Diagnostic agreement was high across a broad range of diagnostic flow cytometry cases encountered in clinical practice. The FL5 survey offers laboratories valuable insight for diagnostic accuracy and comparison of interpretation to that of other laboratories.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interpretive Diagnostic Error Reduction: Guideline Update from the College of American Pathologists in Collaboration With the Association of Directors of Anatomic and Subspecialty Pathology. 减少解释性诊断错误:美国病理学家学会与解剖学和亚专科病理学主任协会合作的指南更新。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-05-27 DOI: 10.5858/arpa.2026-0016-CP
Suzanne M Dintzis, Juanita J Evans, Marisol Hernandez, Tanja Kalicanin, Christina Lacchetti, Raouf E Nakhleh, Christopher N Otis, Liron Pantanowitz, Vinita Parkash, Stephen S Raab
{"title":"Interpretive Diagnostic Error Reduction: Guideline Update from the College of American Pathologists in Collaboration With the Association of Directors of Anatomic and Subspecialty Pathology.","authors":"Suzanne M Dintzis, Juanita J Evans, Marisol Hernandez, Tanja Kalicanin, Christina Lacchetti, Raouf E Nakhleh, Christopher N Otis, Liron Pantanowitz, Vinita Parkash, Stephen S Raab","doi":"10.5858/arpa.2026-0016-CP","DOIUrl":"10.5858/arpa.2026-0016-CP","url":null,"abstract":"<p><strong>Context.—: </strong>In 2016, the College of American Pathologists published an evidence-based guideline to develop recommendations for interpretive diagnostic error reduction in anatomic pathology. New evidence, together with evolving practice environments and the continued adoption of digital technologies, including artificial intelligence, has prompted a review of the guideline.</p><p><strong>Objective.—: </strong>To assess evidence published since the release of the original guideline and update evidence-based recommendations for the reduction of diagnostic errors.</p><p><strong>Design.—: </strong>The College of American Pathologists, in collaboration with the Association of Directors of Anatomic and Subspecialty Pathology, convened a panel of experts to update the 2016 evidence-based guideline. A systematic literature review was conducted to address 4 key questions. Using the Grading of Recommendations Assessment, Development and Evaluation approach, recommendations were created based on the available evidence, certainty of that evidence, and key judgments as defined in the Grading of Recommendations Assessment, Development and Evaluation framework.</p><p><strong>Results.—: </strong>Two strong recommendations and 4 good practice statements were established for the reduction of diagnostic error.</p><p><strong>Conclusions.—: </strong>The expert panel recommends that anatomic pathologists implement procedures for the review of pathology cases to detect and correct potential interpretive errors to improve patient outcomes.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"668-677"},"PeriodicalIF":3.2,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cogitations of a Computational Pathologist: Artificial or Computational-Rethinking Intelligence in the Age of Algorithms. 计算病理学家的认知:算法时代的人工智能还是计算智能。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-05-26 DOI: 10.5858/arpa.2025-0558-ED
Giovanni M Luján
{"title":"Cogitations of a Computational Pathologist: Artificial or Computational-Rethinking Intelligence in the Age of Algorithms.","authors":"Giovanni M Luján","doi":"10.5858/arpa.2025-0558-ED","DOIUrl":"https://doi.org/10.5858/arpa.2025-0558-ED","url":null,"abstract":"","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":"150 6","pages":"422-424"},"PeriodicalIF":3.2,"publicationDate":"2026-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pathology Fellowship Trends From 2015 to 2024: More Openings but Less Interest. 从2015年到2024年病理学研究员趋势:更多的空缺但更少的兴趣。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-05-26 DOI: 10.5858/arpa.2025-0511-LE
Reem O Ahmed, Roxanne Sandhu, Nat Pernick, Debra L Zynger
{"title":"Pathology Fellowship Trends From 2015 to 2024: More Openings but Less Interest.","authors":"Reem O Ahmed, Roxanne Sandhu, Nat Pernick, Debra L Zynger","doi":"10.5858/arpa.2025-0511-LE","DOIUrl":"https://doi.org/10.5858/arpa.2025-0511-LE","url":null,"abstract":"","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":"150 6","pages":"419-421"},"PeriodicalIF":3.2,"publicationDate":"2026-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perspectives on Neuroendocrine and Mixed Neuroendocrine Neoplasms of the Pancreas. 胰腺神经内分泌及混合性神经内分泌肿瘤的研究进展。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-05-26 DOI: 10.5858/arpa.2026-0067-ED
Claudio Luchini, Michelle D Reid
{"title":"Perspectives on Neuroendocrine and Mixed Neuroendocrine Neoplasms of the Pancreas.","authors":"Claudio Luchini, Michelle D Reid","doi":"10.5858/arpa.2026-0067-ED","DOIUrl":"https://doi.org/10.5858/arpa.2026-0067-ED","url":null,"abstract":"","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":"150 6","pages":"e116-e117"},"PeriodicalIF":3.2,"publicationDate":"2026-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transference Validation of Clinically Utilized Immunoassay Reference Intervals: Evidence From Thyroid Function-Related Hormones. 临床使用免疫测定参考区间的转移验证:来自甲状腺功能相关激素的证据。
IF 3.2
Archives of pathology & laboratory medicine Pub Date : 2026-05-22 DOI: 10.5858/arpa.2025-0464-OA
Dan Yang, Yusi Liu, Fanming Jiang, Zihan Su, Xu Wang, Xin Zhang, Shuo Wang, Lei Zhao, Hongyi Wang, Runqing Mu, Min Zhao
{"title":"Transference Validation of Clinically Utilized Immunoassay Reference Intervals: Evidence From Thyroid Function-Related Hormones.","authors":"Dan Yang, Yusi Liu, Fanming Jiang, Zihan Su, Xu Wang, Xin Zhang, Shuo Wang, Lei Zhao, Hongyi Wang, Runqing Mu, Min Zhao","doi":"10.5858/arpa.2025-0464-OA","DOIUrl":"https://doi.org/10.5858/arpa.2025-0464-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Thyroid test standardization is hindered by interplatform variability, especially for immunoassays lacking metrologic traceability. Direct method-derived reference intervals (RIs) are gold standard but resource intensive. RI transference allows cost-effective multiplatform RI establishment but necessitates balanced consideration of statistical relevance, precision, and clinical feasibility.</p><p><strong>Objectives.—: </strong>To validate an RI transference framework for harmonizing RIs across platforms, using thyroid function testing as a model for assays with inconsistent reference standards.</p><p><strong>Design.—: </strong>Dual-platform framework (Roche Cobas e601 versus Beckman DxI 800) using euthyroid community midrange specimens (n = 2423) and pathology-enriched clinical leftovers (n = 300). Weighted Deming regression (constant coefficient of variation [CV]: thyroid-stimulating hormone [TSH], free thyroxine [FT4], total triiodothyronine [TT3]) and standard Deming regression (constant standard deviation: free triiodothyronine [FT3], total thyroxine [TT4]) were applied. Precision was evaluated via multiday temporal stability and concentration-dependent Monte Carlo sample size optimization. Spearman ρ, CV(b), and absolute value of bias ratio (|BR|) were benchmarked against direct RIs.</p><p><strong>Results.—: </strong>To explore multiday sampling, weighted Deming enabled accurate TSH transfer [CV(b) = 2.07%-2.89%] and acceptable precision for FT4/TT3/TT4 [CV(b) = 5.97%-10.82%]. Randomized multiday sampling reduced extreme |BR| outliers by 51% to 89%. To compare concentration-driven data sources, community-derived specimens showed superior alignment with direct RIs (FT3: |BR| = 0.581 versus 1.161 in residuals), despite weaker correlations (ρ = 0.33 versus 0.92) at n = 40. When using community-derived specimens, FT3 exhibited persistent challenges [ρ = 0.33-0.36; CV(b) = 3.07%-23.44%] attributable to methodologic heterogeneity. To determine the adaptive sample size, optimization suggested that 45 prestratified residuals with bootstrap resampling (100 × 40 pairs) improved efficiency but introduced pathologic bias (FT3 |BR| = 1.161).</p><p><strong>Conclusions:: </strong>This study established a comprehensive thyroid testing RI transference framework integrating multiday sampling, adaptive sample size, and concentration-driven data selection, identifying optimal solutions to enable cross-platform RI establishment for immunoassays. Resource-limited laboratories can further leverage multicenter direct RIs via transference to balance cost and clinical validity.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148007590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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