Archives of pathology & laboratory medicine最新文献

{"title":"Breast Cancer Biopsies With Group 2 and Group 4 Human Epidermal Growth Factor Receptor 2 Fluorescence In Situ Hybridization Results Should Have Repeated Testing on Excision.","authors":"Kristina-Ana Klaric, Denis Gravel, Nina Chang, Sarah Strickland, Phillip Williams","doi":"10.5858/arpa.2024-0305-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0305-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Breast cancer with human epidermal growth factor receptor 2 (HER2) fluorescence in situ hybridization (FISH) group 2 (HER2:CEP17 ratio ≥2.0 and HER2 signals <4.0) and group 4 (HER2:CEP17 ratio <2.0 and HER2 signals ≥4.0 and <6.0) patterns represent a small and challenging subset of cases. These special categories were previously considered positive and equivocal, respectively. However, following the 2018 update of the American Society of Clinical Oncology/College of American Pathologists guidelines, these groups were deemed negative unless concurrent immunohistochemistry was 3+. The guidelines indicate repeated HER2 testing on excisional specimens may be appropriate, but retesting is not definitively recommended.</p><p><strong>Objective.—: </strong>To determine if group 2 and group 4 cases change after repeated testing on additional specimens.</p><p><strong>Design.—: </strong>A retrospective review of breast biomarker synoptic reports was conducted from 2016 to 2023. Cases identified as HER2 FISH group 2 and group 4 were recorded, along with the results of any repeated testing.</p><p><strong>Results.—: </strong>A total of 5695 cases with HER2 FISH testing were identified: 101 cases of group 2 (1.8%) and 194 of group 4 (3.4%). There were 42 initial breast biopsies from group 2, and 110 from group 4 with repeated testing on excision. Of these, 5 group-2 (11.9%) and 19 group-4 (17.3%) cases became HER2 positive. None demonstrated positive staining (3+) by immunohistochemistry. There was no association with receipt of neoadjuvant therapy or triple-negative status in either group.</p><p><strong>Conclusions.—: </strong>We recommend that breast biopsies with group 2 and 4 FISH results have HER2 testing repeated on the excisional specimen.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143598559","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}

{"title":"Clinical Evaluation of the Heparin Therapeutic Window Using Activated Clotting Time in Neurological Interventional Radiology at an Academic Medical Center.","authors":"Melody B Nelson, Amitava Dasgupta, X Long Zheng","doi":"10.5858/arpa.2024-0399-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0399-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Activated clotting time (ACT) is useful for monitoring heparin therapy in neurointerventional radiology (NIR). We previously used the Hemochron Signature Elite instrument for measuring ACT in NIR.</p><p><strong>Objective.—: </strong>To evaluate the suitability of measuring ACT using i-STAT in NIR by comparing its performance with Hemochron and a laboratory-based anti-Xa (anti-factor Xa) assay.</p><p><strong>Design.—: </strong>All ACT measurements were performed in duplicate, using 2 Hemochron and 2 i-STAT devices in 53 samples from 15 unique multidose heparin administrations in NIR procedures and 110 samples in cardiovascular procedures. Samples were tested simultaneously within 1 minute of each other.</p><p><strong>Results.—: </strong>For 12 of the 15 procedures in NIR, anti-Xa was assessed at the beginning of the procedure and at the end of all procedural dosing. We also reviewed the patient's charts anonymously for any indication of postprocedural neurological bleeding. Interinstrument variability was much higher with Hemochron than with i-STAT. We also observed lower ACT values with i-STAT than with Hemochron. Therefore, the historical ACT range of 250 to 300 seconds for Hemochron was revised to 200 to 250 seconds for i-STAT devices. In the therapeutic window for anti-Xa, ACT results from both instruments exhibited a linear correlation. However, at supratherapeutic range for anti-Xa, ACT results from Hemochron exhibited more linear correlation, while i-STAT ACT demonstrated a plateau effect. No patient had any evidence of severe postprocedural neurological bleeding.</p><p><strong>Conclusions.—: </strong>The i-STAT analyzers produce more reproducible ACT results, but the target range should be lowered to 200 to 250 seconds. This range appears to provide adequate and safe heparin therapy, confirmed by anti-Xa assay results and clinical outcome.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143588600","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}

{"title":"Standardization of Bone Marrow Reporting for Myelodysplastic Syndromes/Neoplasms on Behalf of the International Consortium for Myelodysplastic Syndromes/Neoplasms.","authors":"Savanah D Gisriel, Fnu Aakash, John M Bennett, Robert P Hasserjian, Sanam Loghavi, Amy E DeZern, Valeria Santini, Michael R Savona, Andrew M Brunner, Rena Buckstein, Andrew H Wei, Matteo G Della Porta, Rami S Komrokji, Uma M Borate, Mikkael A Sekeres, Uwe Platzbecker, Pierre Fenaux, Gail J Roboz, Arjan van de Loosdrecht, Amer M Zeidan, Mina L Xu","doi":"10.5858/arpa.2024-0322-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0322-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Standardized bone marrow reporting specifically for myelodysplastic syndromes/neoplasms (MDS) is currently lacking in the literature and much needed in practice.</p><p><strong>Objective.—: </strong>To propose a standardized approach to MDS evaluation in bone marrow specimens by (1) enhancing interinstitutional and intrainstitutional collaborations and clinical decision-making among hematopathologists and clinical hematologists and (2) allowing for efficient data extraction for clinical trials, institutional databases, and registry templates. This suggested approach is summarized in a modifiable, user-friendly template for hematopathologists to reference as they examine bone marrows (in the Supplemental Digital Content).</p><p><strong>Data sources.—: </strong>We built upon the bone marrow template reporting guideline outlined by the College of American Pathologists Pathology and Laboratory Quality Center for Evidence-Based Guidelines and gathered expert insight from hematopathologists and hematologists-oncologists who specialize in MDS.</p><p><strong>Conclusions.—: </strong>This proposed approach to MDS evaluation in the bone marrow standardizes reporting, which enhances communication among health care professionals and allows for efficient data extraction.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143588628","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}

{"title":"The State of Pathology Student Interest Groups in Allopathic and Osteopathic Medical Schools in the United States: Current Practices and Opportunities for Improvement.","authors":"Cullen M Lilley, Kamran M Mirza, Kalisha Hill","doi":"10.5858/arpa.2024-0279-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0279-OA","url":null,"abstract":"<p><strong>Context.—: </strong>With the gradual decline in pathology residency applicants during the past few decades, the successful recruitment of quality medical students into the field will rely on a multidimensional approach. One of the means by which medical students are exposed to and recruited into the field of pathology is through student interest groups (SIGs). Though SIGs have been cited as a successful method for recruitment, the strategies for running a successful SIG have not been fully explored.</p><p><strong>Objective.—: </strong>To assess the functioning of pathology SIGs and provide a cross-sectional analysis of the challenges pathology SIGs face, what resources are needed, and how national organizations can most effectively support their functioning.</p><p><strong>Design.—: </strong>A multi-institutional survey was developed and deployed in December 2023 via email to College of American Pathologists medical student members and Future Pathologist Champions.</p><p><strong>Results.—: </strong>Of the 125 responses elicited from medical student members and Future Pathologist Champions, 78% (n = 97) indicated their institution had a pathology SIG. Faculty members were noted to be an important aspect to the SIG's success, especially by providing guidance and mentorship. Respondents also touted the regular hosting of events as another key component to success. Importantly, when asked about funding, most of the 78 respondents reported that their pathology SIGs relied on funding from their institution (58%; n = 45), but a large minority also received funding through grants/scholarships (36%; n = 28) or sponsorships from external organizations (28%; n = 22).</p><p><strong>Conclusions.—: </strong>This study provides a first-of-its-kind quantitative and qualitative account of the establishment and maintenance of pathology SIGs from the personnel participating in their daily functioning.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143544105","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}

{"title":"Differentiation Versus Grade for Pancreatic Neuroendocrine Neoplasms.","authors":"Guido Rindi, Frediano Inzani","doi":"10.5858/arpa.2024-0410-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0410-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Pancreatic neuroendocrine neoplasia (panNEN) is a tumor disease with distinctive morphology and often poses diagnostic challenges.</p><p><strong>Objective.—: </strong>To present and discuss the current diagnostic criteria of PanNEN.</p><p><strong>Data sources.—: </strong>PanNENs are classified by the World Health Organization (WHO) criteria into well-differentiated neuroendocrine tumor (panNET) and poorly differentiated neuroendocrine carcinoma (panNEC) of large or small cell type. panNETs are graded as G1-G3 on the basis of their proliferation capacity by mitotic count and/or Ki-67 proliferation index. Differentiation and grading are overlapping tools essentially directed to the definition of tumor cell resemblance to the normal cell counterpart (differentiation) and its proliferation capacity (grading). Both tools aim at defining the panNEN malignant potential, and ultimately the overall and event-free survival. The 2 panNEN families mirror different molecular backgrounds. The panNET genotype consistently displays mutation/copy number variation of DAXX (death domain associated protein), ATRX (ATRX chromatin remodeler), and MEN1 (menin 1) genes, while in panNEC the usual cancer drivers TP53 (tumor protein 53), RB1 (RB transcriptional corepressor 1), and KRAS (KRAS proto-oncogene, GTPase) genes are mutated/abnormal. The more subtle differences measured by grade in panNET G1-G3 reflect a progressive gene disorder, with G3 often involving TP53. This rare genetic setting is usually associated with a difficult differential diagnosis between panNET G3 and panNEC. Immunohistochemistry for the informative genes DAXX, ATRX, TP53, RB1, P16 (cyclin-dependent kinase inhibitor 2A), and SST2 (somatostatin receptor 2) are the key to separating panNETG3 and panNEC; however, molecular investigation is often required and decisive. Nonetheless, ambiguous cases may remain unresolved.</p><p><strong>Conclusions.—: </strong>The WHO diagnostic criteria for panNEN are simple and effective tools for a clinically meaningful patient stratification. Areas of uncertainty remain and deserve further investigation.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543930","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}

{"title":"Comparison of Molecular Testing Methodologies for CIC-Rearranged Sarcomas.","authors":"Selene C Koo, Maria Cardenas, Patricia Stow, Jennifer Neary, David A Wheeler, Zonggao Shi, Larissa V Furtado","doi":"10.5858/arpa.2024-0407-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0407-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Molecular detection of a capicua transcriptional repressor (CIC) rearrangement is critical for diagnosing CIC-rearranged sarcoma (CIC-RS) but is analytically challenging.</p><p><strong>Objective.—: </strong>To compare the technical performance of fluorescence in situ hybridization (FISH), whole-transcriptome sequencing (RNA-seq), and DNA methylation profiling for CIC-rearrangement detection in a large, mainly pediatric cohort.</p><p><strong>Design.—: </strong>The study cohort consisted of 44 distinct patient tumors that were positive, equivocal, or suggestive for CIC rearrangement, including 18 central nervous system and 26 extra-central nervous system solid tumors. Forty tumors underwent FISH to detect CIC rearrangement, 31 underwent transcriptome sequencing, and 34 underwent methylation array analysis. Results for tumors tested by multiple testing modalities were compared.</p><p><strong>Results.—: </strong>Fusions were detected in 27 cases: CIC::double homeobox 4 (DUX4) (n = 15), CIC::NUT midline carcinoma family member 1 (NUTM1) (n = 4), CIC::leucine twenty homeobox (LEUTX) (n = 3), CIC::NUT family member 2B (NUTM2B) (n = 1), ataxin 1 (ATXN1)::NUTM1 (n = 1), ATXN1::NUT family member 2A/B (NUTM2A/B) (n = 1), CIC::DUX4 proximity effect (n = 1), and dedicator of cytokinesis 1 (DOCK1)::DUX4 (n = 1). Twenty-five tumors were tested by all 3 testing modalities. Apparent false-negative rates were 20% (3 of 15) for CIC FISH, 14% (2 of 14) for transcriptome sequencing, and 14% (2 of 14) for methylation array analysis. Both false-negative methylation array results had CIC::LEUTX fusion.</p><p><strong>Conclusions.—: </strong>Awareness of molecular testing pitfalls in the appropriate detection of CIC rearrangement is critical. Any CIC FISH result may need to be further confirmed, either with unequivocal immunohistochemical support or by another molecular method. A positive RNA-seq or methylation array analysis result may be sufficient evidence for a diagnosis of CIC-RS in the appropriate histologic context. A negative or inconclusive/unclassified RNA-seq or methylation array analysis result in a tumor with high initial suspicion for CIC-RS likely requires careful reevaluation.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476896","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}

{"title":"Loss of H3K27me3 Is Not Specific to Malignant Triton Tumor: Immunohistochemical Analysis of 23 Cases of Embryonal Rhabdomyosarcoma.","authors":"Laura M Warmke, Jessica L Davis, Alyaa Al-Ibraheemi, Michael Arnold, Serena Tan, Archana Shenoy, Lea F Surrey, David M Parham, Erin R Rudzinski","doi":"10.5858/arpa.2024-0199-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0199-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Malignant peripheral nerve sheath tumor (MPNST) is a rare, often high-grade sarcoma. A small subset of MPNST shows evidence of heterologous rhabdomyoblastic differentiation, also known as malignant triton tumor (MTT). Immunohistochemical loss of histone 3 lysine 27 trimethylation (H3K27me3) has previously been described as a reliable marker for both MPNST and MTT.</p><p><strong>Objective.—: </strong>To assess the loss of H3K27me3 as a potential tool for discriminating MTT from embryonal rhabdomyosarcoma (ERMS).</p><p><strong>Design.—: </strong>We studied the immunohistochemical expression of H3K27me3 in 23 pediatric cases of confirmed ERMS. Of the 23 patients, 21 were male and 2 were female, with an age range of 2 months to 18 years (median, 5 years). Most of the tumors arose in the paratesticular soft tissue (n = 14), with other locations including the pelvis (n = 3), thigh (n = 2), abdomen (n = 1), orbit (n = 1), prostate gland (n = 1), and parotid gland (n = 1). All cases had characteristic morphologic features of ERMS.</p><p><strong>Results.—: </strong>By immunohistochemistry, all tested cases expressed desmin (18 of 18), myogenin (20 of 20), and MyoD1 (5 of 5). More than half of the cases (12 of 23; 52%) showed loss (nuclear absence) of H3K27me3, defined as staining in less than 5% of the tumor cells. The remaining cases demonstrated some degree of partial staining with H3K27me3, ranging from 5 to 40% of the tumor cells. No significant correlation between H3K27me3 expression and clinicopathologic features was identified.</p><p><strong>Conclusions.—: </strong>Loss of H3K27me3 frequently occurs in ERMS (52%) and is not reliable in distinguishing ERMS from MTT.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434583","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}

{"title":"Artificial Intelligence-Based Classification of Renal Oncocytic Neoplasms: Advancing From a 2-Class Model of Renal Oncocytoma and Low-Grade Oncocytic Tumor to a 3-Class Model Including Chromophobe Renal Cell Carcinoma.","authors":"Katrina Collins, Shubham Innani, Kingsley Ebare, Mohammed Saad, Stephanie E Siegmund, Sean R Williamson, Fiona Maclean, Andres Matoso, Ankur Sangoi, Michelle S Hirsch, Dibson D Gondim, Andres M Acosta, Bhakti Baheti, Spyridon Bakas, Muhammad T Idrees","doi":"10.5858/arpa.2024-0374-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0374-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Distinguishing between renal oncocytic tumors, such as renal oncocytoma (RO), and a subset of tumors with overlapping characteristics, including the recently identified low-grade oncocytic tumor (LOT), can present a diagnostic challenge for pathologists owing to shared histopathologic features.</p><p><strong>Objective.—: </strong>To develop an automatic computational classifier for stratifying whole slide images of biopsy and resection specimens into 2 distinct groups: RO and LOT.</p><p><strong>Design.—: </strong>A total of 269 whole slide images from 125 cases across 6 institutions were collected. A weakly supervised attention-based multiple-instance-learning deep learning (DL) model was trained and initially evaluated through 5-fold cross validation with case-level stratification, followed by validation using an independent holdout data set. Quantitative performance evaluation was based on accuracy and the area under the receiver operating characteristic curve (AUC).</p><p><strong>Results.—: </strong>The developed model data set yielded generalizable performance, with a 5-fold average testing accuracy of 84% (AUC = 0.78), and a closely aligning accuracy of 83% (AUC = 0.92) on the independent holdout data set.</p><p><strong>Conclusions.—: </strong>The proposed artificial intelligence approach contributes toward a comprehensive solution for addressing commonly encountered renal oncocytic neoplasms, encompassing well-established entities like RO along with the challenging \"gray zone\" LOT, thereby proving applicable in clinical practice.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434579","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}

{"title":"Turnaround Time for Image-Guided Breast Core Biopsies: A College of American Pathologists Survey Q-Probes Study.","authors":"Anthony J Guidi, Barbara J Blond, Thomas A Long, Suzanne N Coulter, Richard W Brown","doi":"10.5858/arpa.2024-0316-CP","DOIUrl":"https://doi.org/10.5858/arpa.2024-0316-CP","url":null,"abstract":"<p><strong>Context.—: </strong>Timely breast core biopsy results help expedite appropriate treatment for patients. Many institutions track turnaround times from biopsy to report; however, there are no established benchmarks to evaluate performance and identify potential improvement opportunities.</p><p><strong>Objective.—: </strong>To determine benchmark turnaround times for breast core biopsy reports and identify key drivers impacting turnaround time.</p><p><strong>Design.—: </strong>Participants enrolled in the College of American Pathologists Q-Probes study entitled Turnaround Time for Image-Guided Breast Needle Biopsy Specimens provided intervals for processing steps through report completion, and details regarding potential influencing variables.</p><p><strong>Results.—: </strong>Nineteen participants submitted data for 876 cases. The median turnaround time from accession to report completion was 31.0 hours, with a median time of 19.2 hours from accessioning to slide delivery to pathologists. The median time from biopsy to accessioning (3.4 hours) and slide delivery to report completion (7.5 hours) was notably shorter. Cases with malignant diagnoses were associated with longer median turnaround times than those with benign/atypical/borderline diagnoses (44.1 versus 29.4 hours; P = .04). Cases requiring additional testing or consultation were associated with longer median turnaround times than straightforward cases (45.3 versus 27.4 hours; P < .001). Fixation time variability was noted between laboratories (median, 11.0 hours; 10th and 90th percentile times: 7.1 and 31.3 hours, respectively). Variability was seen in the total processing times among laboratories (mean, 9.1 hours; range, 4.5-12.5 hours).</p><p><strong>Conclusions.—: </strong>Participating laboratories provided timely breast core biopsy results. Benchmark data presented may be useful for laboratories to assess performance and develop strategies for improvement.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434585","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}

{"title":"A Multicenter Study to Evaluate Diagnostic Accuracy by Pathologists Using the Aperio GT 450 DX in Local and Remote Viewing Stations.","authors":"Alexander D Borowsky, Dylan V Miller, Thomas W Bauer, Richard M Feddersen, Dorina Gui, Brian J Hall, James E Albro, Isaac E Lloyd, John W Bishop, Morgan A Darrow, James H Spigel, David R Martin, Samuel J Reynolds, Thomas G McConnell, Eric F Glassy, Jonathan Zuckerman, Nathash S Kallichanda, Xiaozhi Zhou, Jenny V Lewis, Shubham Dayal, Joseph Chiweshe, Aysegul Ergin Sutcu, Michael White","doi":"10.5858/arpa.2024-0204-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0204-OA","url":null,"abstract":"<p><strong>Context.—: </strong>The adoption of digital pathology may enable pathologists to perform primary diagnosis in both local and remote whole slide image viewing settings, improving logistics and convenience.</p><p><strong>Objective.—: </strong>To test the performance of a new whole slide imaging system (Aperio GT 450 DX), both local intranet-based and remote internet-based viewing were compared with manual glass slide light microscopy.</p><p><strong>Design.—: </strong>A total of 1161 curated cases, enriched with difficult clinical diagnoses, were enrolled in this accuracy study and digitally scanned on 3 Aperio GT 450 DX instruments at 3 clinical sites. Ten reading pathologists across the 3 study sites viewed images either locally (directly connected to the image server) or remotely (viewed over an internet connection). Each diagnosis was scored (concordant, minor, or major discrepancy) by a separate team of 3 adjudication pathologists. The diagnostic accuracy of the Aperio GT 450 DX was tested by comparing the whole slide image review diagnosis with the conventional light microscope manual slide review diagnosis.</p><p><strong>Results.—: </strong>The difference in the major discrepancy rate between whole slide image review diagnosis and manual slide review diagnosis was 2.40% (95% CI, 1.40%-3.39%), meeting the predefined acceptance criterion of the 95% CI upper bound of 4% or less. Secondary end points were also met, including an upper bound of 7% or less and both local-only and remote-only upper-bound discrepancy rates of 4% or less. Major discrepancies were slightly lower for the remotely viewed cases (2.17%) compared with local direct server connection (2.61%), and time per read was not different.</p><p><strong>Conclusions.—: </strong>The diagnoses made using the Aperio GT 450 DX, using both local and remote access image data, are noninferior to the diagnoses made using conventional light microscopy.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143411665","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}