American journal of clinical pathology最新文献

{"title":"Gallbladder amyloidosis is often unexpected and may have systemic implications.","authors":"Catherine E Hagen, Surendra Dasari, Jason D Theis, Karen Rech, Linda Dao, Matthew Howard, Daniel P Larson, Samih H Nasr, Angela Dispenzieri, April Chiu, Joanna Dalland, Morie Gertz, Taxiarchis Kourelis, Eli Muchtar, Julie A Vrana, Ellen D McPhail","doi":"10.1093/ajcp/aqaf090","DOIUrl":"10.1093/ajcp/aqaf090","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to evaluate a large cohort of gallbladder amyloid cases to determine clinical and morphologic features.</p><p><strong>Methods: </strong>Cholecystectomy specimens (N = 118) typed using proteomics-based techniques between 2008 and 2023 were identified. Clinical and morphologic features were reviewed.</p><p><strong>Results: </strong>Six amyloid types were identified: ATTR (n = 63, 53.4%), AL (n = 46, 39.0%), AA (n = 4, 3.4%), AApoA1 (n = 2, 1.7%), ALECT2 (n = 2, 1.7%), and AEFEMP1 (n = 1, 0.8%). Amyloidogenic mutations were detected in 3 ATTR cases and 2 AApoA1 cases. Morphologic review (n = 26) revealed perimuscular vessel involvement in all cases. Amyloidosis was an unexpected diagnosis first made on the cholecystectomy specimen in half of the patients with clinical information (n = 10). All 9 patients with follow-up had evidence of systemic disease. In 2 patients, cholecystic involvement was initially missed and only retrospectively identified after the diagnosis of cardiac amyloidosis.</p><p><strong>Conclusions: </strong>In patients with clinical data, amyloidosis was often unexpected, the gallbladder was commonly the first tissue sampled with amyloidosis, and all patients had systemic disease. Thorough review of cholecystectomy specimens with careful inspection of perimuscular vessels, coupled with a low threshold for ordering Congo red stain in elderly individuals and amyloid typing using a robust method such as proteomics, can prevent a delay in amyloid diagnosis and management.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"613-619"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An immunohistochemical germinal center B-cell dark zone signature identifies Burkitt lymphoma and molecular high-grade B-cell lymphomas.","authors":"Xiaoxian Zhao, Alexandra Balmaceda, Via S Abiera, Lisa M Rimsza, Desiree Garber, Lynne S Rosenblum, David W Scott, Eric D Hsi","doi":"10.1093/ajcp/aqaf074","DOIUrl":"10.1093/ajcp/aqaf074","url":null,"abstract":"<p><strong>Objective: </strong>We hypothesized that a set of immunohistochemistry (IHC) stains could be used to distinguish Burkitt lymphoma (BL), the quintessential B-cell lymphoma with a germinal center B-cell (GCB) dark zone (DZ) expression signature, from diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS). This might also be applicable to high-grade B-cell lymphomas (HGBCLs) with MYC and BCL2 rearrangements (double-hit lymphomas [DHLs]) and triple-hit lymphomas (THLs).</p><p><strong>Methods: </strong>A 5-marker IHC algorithm was designed from gene lists that distinguish physiologic DZ from light zone GCBs.</p><p><strong>Results: </strong>In training and validation cohorts, we distinguished BL from DLBCL, NOS with high sensitivity and specificity. Because DHLs/THLs are enriched for the gene expression DZ signature (DZsig), we evaluated 19 DHLs/THLs and 4 HGBCLs, NOS. Most (83%) cases were IHC DZ. The NanoString DLBCL90 assay was performed on 34 cases to correlate IHC DZ results with the molecular DZsig. The IHC DZ call was significantly associated with the DZsig (P = .0011). The sensitivity and specificity of IHC to recognize DZsig+ cases among DLBCL, NOS and DHLs with BCL2 rearrangements/THLs were 91% and 100%, respectively.</p><p><strong>Conclusions: </strong>The IHC DZ algorithm can support a diagnosis of BL and identifies MYC-BCL2 DHLs/THLs with a molecular DZsig.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"559-566"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reproducibility of Ki67 Haralick entropy as a prognostic marker in estrogen receptor-positive HER2-negative breast cancer.","authors":"Dovile Zilenaite-Petrulaitiene, Allan Rasmusson, Ruta Barbora Valkiuniene, Aida Laurinaviciene, Linas Petkevicius, Arvydas Laurinavicius","doi":"10.1093/ajcp/aqaf081","DOIUrl":"10.1093/ajcp/aqaf081","url":null,"abstract":"<p><strong>Objective: </strong>Intratumoral heterogeneity (ITH) of Ki67 expression reflects the proliferative diversity of breast cancer (BC) cells and has been associated with disease progression. Quantification of Ki67 ITH using Haralick entropy metric from digital image analysis (DIA) has been reported as an independent predictor of breast cancer-specific survival (BCSS); however, its reproducibility across DIA platforms and dependence on tumor tissue sampling have not been investigated.</p><p><strong>Methods: </strong>Whole-slide images of Ki67-stained tumor sections from 254 patients with ER+/HER2- BC were analyzed independently using HALO and Aiforia DIA platforms. The DIA outputs were subsampled using hexagonal grids to compute Ki67 Haralick entropy. Reproducibility was tested across DIA platforms and under simulated surgical excision and core biopsy scenarios. Lastly, the impact on prognostic modeling for BCSS was assessed.</p><p><strong>Results: </strong>Haralick entropy demonstrated strong Ki67 ITH cross-platform reproducibility. For prognosis, it provided stronger model performance than conventional Ki67% metrics and independently predicted worse BCSS alongside lymph node involvement. Its prognostic value remained consistent across simulated sampling scenarios.</p><p><strong>Conclusions: </strong>Ki67 Haralick entropy is a reproducible and robust image-derived ITH metric in ER+/HER2- BC. It demonstrated improved prognostic modeling performance compared to conventional Ki67% across 2 different DIA platforms and sampling conditions, supporting its potential for clinical implementation.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"567-580"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495521/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144833704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a fully automated ADAMTS13 activity assay utilizing fluorescence resonance energy transfer with a practical approach to address high background fluorescence interference.","authors":"Jing Jin, Lu M Yang, Derick Okwan, James L Zehnder","doi":"10.1093/ajcp/aqaf061","DOIUrl":"10.1093/ajcp/aqaf061","url":null,"abstract":"<p><strong>Objective: </strong>This study evaluates an automated fluorescence resonant energy transfer (FRET)-based ADAMTS13 activity assay on the Ceveron S100 instrument for the diagnosis of thrombotic thrombocytopenic purpura. It addresses the challenge of high background fluorescence (HBF), a known concern from our manual FRET assay, and proposes strategies to minimize erroneous results.</p><p><strong>Methods: </strong>We compared FRET-Ceveron results with FRET-Manual (n = 100) and Technozym (Technoclone) enzyme-linked immunosorbent assay (ELISA) (n = 52) using retrospective and prospective patient samples collected throughout 2024, alongside proficiency samples and standards with assigned values (n = 24). We analyzed 7 spiked samples with HBF and 14 patient samples exhibiting HBF while exploring predilution methods. Over 200 FRET-Ceveron reactions were examined to identify abnormal patterns and establish thresholds for HBF interference.</p><p><strong>Results: </strong>The FRET-Ceveron assay demonstrated a strong correlation (r² > 0.97) with Technozym ELISA, FRET-Manual, and target results. It successfully detected critically low ADAMTS13 levels (<10%) across various sample types (n = 15). While HBF affected both FRET methods, FRET-Ceveron displayed greater tolerance to HBF. No significant difference was found in FRET-Ceveron result accuracy for initial carbon nanotubes (CNTs) up to 1100 (P = .39), but significant differences were observed when CNTs exceeded 1100 (P = .02). Predilution effectively reduced HBF (P < .05), validating the results confirmed by Technozym ELISA.</p><p><strong>Conclusions: </strong>The fully automated FRET-Ceveron assay is a rapid and accurate method for ADAMTS13 testing, and it is particularly effective when a normal reaction pattern is observed (initial CNTs ≤1000 with a good linearity in reaction tracing during 7- to 22-minute measurements). New sample collection is preferred in the presence of HBF, with predilution as a viable option.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"545-558"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying false-positive chlamydia and gonorrhea results using nonmanufacturer relative light unit cutoffs for the Aptima Combo 2 Assay.","authors":"Savannah N Rios, Derrick J Chen","doi":"10.1093/ajcp/aqaf085","DOIUrl":"10.1093/ajcp/aqaf085","url":null,"abstract":"<p><strong>Objective: </strong>Chlamydia trachomatis and Neisseria gonorrhoeae present substantial public health challenges. Accurate diagnostic testing is essential to prevent misdiagnosis and unnecessary treatment. Although nucleic acid amplification tests offer excellent performance, they are not infallible. This study sought to evaluate the semiquantitative utility of relative light unit (RLU) values from the Hologic Aptima Combo 2 Assay to improve the diagnostic accuracy of testing for C trachomatis and N gonorrhoeae.</p><p><strong>Methods: </strong>Data were analyzed from January 2021 to December 2021. Manufacturer guidelines define results as positive if the RLU value is above 100 for C trachomatis only, above 150 for N gonorrhoeae only, and above 250 for dual C trachomatis and N gonorrhoeae detection; equivocal if the RLU value is 25 to 99 for C trachomatis, 60 to 149 for N gonorrhoeae, and 85 to 249 for both; and negative if the RLU value is below 25 for C trachomatis, below 60 for N gonorrhoeae, and below 85 for both. Manufacturer guidance recommends repeat testing only for equivocal results. In contrast, the University of Wisconsin University Hospital adopted a modified criterion, classifying all results with an RLU value at or below 900 as equivocal and requiring repeat testing.</p><p><strong>Results: </strong>In this retrospective review of 20 875 Aptima Combo 2 assays performed from January to December 2021, 7 patients had initial positive results, with RLU values at or below 900. Of these, 5 were ultimately determined to be false positives.</p><p><strong>Conclusions: </strong>These findings demonstrate that expanding the definition of equivocal results to include low positive RLU values (≤900) increases identification of false positives with minimal additional repeat testing. This modified approach may improve diagnostic specificity and reduce unnecessary treatment and patient anxiety.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":"608-612"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The American Society for Clinical Pathology 2024 Vacancy Survey of medical laboratories in the United States.","authors":"Edna Garcia, Jenny Diaz, Iman Kundu, Melissa Kelly, Ryan Soles","doi":"10.1093/ajcp/aqaf101","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf101","url":null,"abstract":"<p><strong>Objective: </strong>We sought to determine the extent and distribution of workforce shortages within US medical laboratories.</p><p><strong>Methods: </strong>The survey was conducted through collaboration between the American Society for Clinical Pathology's (ASCP's) Institute for Science, Technology and Policy in Washington, DC, and the Evaluation, Measurement and Assessment Department and ASCP Board of Certification in Chicago, Illinois. Data were collected using an internet survey distributed to individuals in a position to report on staffing and certifications for their laboratories.</p><p><strong>Results: </strong>Findings from the ASCP 2024 Vacancy Survey indicate that although vacancy rates have declined compared with 2022, they remain elevated relative to those observed before the COVID-19 pandemic. Retirement rates continue to rise, with 10 of the 17 laboratory departments surveyed reporting increases. Among surveyed laboratory departments, the most frequently cited concern regarding artificial intelligence was the challenge of adapting to emerging technologies. Despite this sentiment, the perceived potential of artificial intelligence to transform laboratory operations remains a major source of enthusiasm.</p><p><strong>Conclusions: </strong>Current vacancy survey data suggest continued challenges in recruitment of laboratory professionals. Qualitative analysis results show that there is an urgent need for advocacy for laboratory professionals, increased credentialing of laboratory professionals, and an increase in the number of laboratory education and training programs.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interobserver agreement and histologic analysis of atypical ductal hyperplasia bordering on ductal carcinoma in situ: A multi-institutional study.","authors":"Ujunwa Korie, Di Ai, Peter Podany, Huina Zhang, Haiying Zhan, Mohamed Kahila, Lorraine Colon-Cartagena, Shi Wei, Hongxia Sun, Jing Du, Uma Krishnamurti, Yuanxin Liang","doi":"10.1093/ajcp/aqaf088","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf088","url":null,"abstract":"<p><strong>Objective: </strong>Atypical ductal hyperplasia (ADH) shares histologic features with low-grade ductal carcinoma in situ (DCIS). \"ADH bordering on DCIS\" represents a diagnostic gray zone with variable interobserver agreement, complicating clinical management.</p><p><strong>Methods: </strong>We retrospectively analyzed 54 cases of ADH bordering on DCIS between 2010 and 2023. Each case underwent independent histologic review by multiple breast pathologists from different institutions. Histologic features, radiologic findings, clinical follow-up data, and interobserver agreement were analyzed.</p><p><strong>Results: </strong>While pathologists showed moderate to substantial agreement on individual histologic features, agreement in distinguishing ADH from DCIS was poor (κ = 0.16). Lesion extent (47.7%) was the most frequently cited diagnostic factor, followed by nuclear features (24.9%) and duct involvement (18.5%). Among biopsy cases, those with carcinoma (DCIS or invasive) on subsequent excision (n = 22) were compared to those without (n = 16). Nuclear size more than 2-fold of background epithelial cells (P = .02), spindle-shaped nuclei (P = .006), and necrosis (P = .048) were significantly associated with carcinoma on excision. The presence of any 1 feature had 36.4% sensitivity and 72.2% specificity.</p><p><strong>Conclusions: </strong>Breast pathologists demonstrated substantial agreement on individual histologic features but poor agreement on final diagnoses, likely due to differences in weighting histologic parameters. While lesion extent was frequently cited, it did not significantly differ between cases with and without carcinoma on excision. Instead, nuclear enlargement, necrosis, and spindle-shaped nuclei were significantly associated with carcinoma in subsequent excision. We propose that biopsy cases exhibiting a nuclear size more than 2-fold of background epithelial cells, necrosis, or spindle-shaped nuclei should be suggestive of DCIS.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Secondary review of extramural hematopathology cases for patients referred to an academic center: The increasing importance of subspecialized hematopathology practice.","authors":"Hans Magne Hamnvag, Steven Van Norman, Yuxuan Chen, Kristen M Pettit, Lili Zhao, Daniel Boyer, Noah Brown, Winston Y Lee, Charles W Ross, Russell Ryan, Lauren B Smith, Riccardo Valdez, Anamarija M Perry","doi":"10.1093/ajcp/aqaf105","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf105","url":null,"abstract":"<p><strong>Objective: </strong>We sought to investigate the frequency of diagnostic changes in hematopathology cases referred to the University of Michigan during a 3-year period and explore which parameters contribute to diagnostic change.</p><p><strong>Methods: </strong>Pathology reports from hematology patients who came to the University of Michigan for a second opinion from 2017 to 2019 were reviewed. Diagnostic discrepancies were classified into major or minor. Specimen type, hematopathology board certification and practice time of the outside pathologists, referring practice type, and whether the second review was done at the referring institution were recorded too. Agreement in diagnosis by the above-listed specimen characteristics was analyzed.</p><p><strong>Results: </strong>A total of 2786 cases were reviewed (2016 bone marrow and 770 tissue specimens). Disagreements in diagnosis were found in 263 cases (9.4% of total cases), and 163 (5.9%) were major disagreements. Among the major disagreements, 119 (73%) were in bone marrow specimens and 44 (27%) in tissue specimens. Among bone marrows, the most common revisions were myeloid neoplasm reclassifications (35.3%), whereas lymphoma subtype revisions comprised 70.4% of all changes in tissues. Univariate analysis showed that major disagreement rates were significantly higher in cases signed out by pathologists without hematopathology certification, those practicing for more than 10 years, and in cases from nonacademic institutions. When analyzing bone marrows and tissues separately, these differences remained significant only for bone marrows.</p><p><strong>Conclusions: </strong>Second review of pathology material serves as an important quality assurance and patient safety measure. Lack of hematopathology training of the referring pathologists may contribute to the rate of diagnostic discrepancy.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep learning model for automated detection of Helicobacter pylori and intestinal metaplasia on gastric biopsy digital whole slide images.","authors":"Li Y Khor, Calvin C Neo, Karthik Prathaban, Esther Choa, Wai K Quah, Eunice N Lum, Raphael Chen, Seow Y Heng, Valerie C Koh, Jia X Seow, Nagalakshmi Jegannathan, Ruoyu Shi, Shihleone Loong, Lee H Song, Anand Natarajan, Sudha Ravi, Kevin S Oh, Chee L Cheng","doi":"10.1093/ajcp/aqaf110","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf110","url":null,"abstract":"<p><strong>Objective: </strong>To develop an automated detection tool for Helicobacter pylori (HP) microorganisms (HPOrg) and intestinal metaplasia (IM) identification on gastric biopsy specimens on hematoxylin and eosin (H&E) whole-slide images (WSIs), incorporating background histopathologic features.</p><p><strong>Methods: </strong>A total of 180 H&E gastric biopsy WSIs, archived at the Department of Anatomical Pathology, Singapore General Hospital, were used to train, validate, and test (60:20:20) a decision support tool. Eighty WSIs displayed non-HP inflammation; 100 were annotated for HP-associated gastritis, HPOrg, and IM. A 2-stage model was employed-a Vision Transformer-based model filtered artifacts after stain normalization, and then a Graph Attention Network component aggregated patch-level features, giving a prediction for each of 6 tissue sections within each WSI, with a majority vote determining the final WSI prediction.</p><p><strong>Results: </strong>A total of 776 636 patches were used for training/validation and testing. The optimized model showed HPOrg classification (precision: 0.604, F1-score: 0.617, and top 10 micro F1-score: 0.714) and IM classification (precision: 0.905, F1-score: 0.861, and top 10 micro F1-score: 1.0). The macro average F1-score was 0.739, section-level precision was 0.981, and the F1-score was 0.945. The WSI-level precision achieved was 1.0, with a F1-score of 0.96.</p><p><strong>Conclusions: </strong>We demonstrate a 2-stage model to detect HP and IM in gastric biopsy specimens, considering background inflammation, which more closely reflects real-world clinical diagnosis.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the Genius Digital Diagnostics System on workflow and accuracy compared with the ThinPrep Imaging System for review of ThinPrep Papanicolaou tests.","authors":"Kathleen M Murphy, Kristina Weatherhead, Carrie Chenault, Chinh Nguyen, Kari Sefcik, Sarah Harrington, Kasey Johnson, Yan Lemeshev","doi":"10.1093/ajcp/aqaf099","DOIUrl":"https://doi.org/10.1093/ajcp/aqaf099","url":null,"abstract":"<p><strong>Objective: </strong>In this study, we compared the workflow of the Genius Digital Diagnostics System (Hologic, Inc) with our current workflow based on the ThinPrep Imaging System (Hologic, Inc) to assess potential efficiencies associated with digitalization of Papanicolaou screening.</p><p><strong>Methods: </strong>Each step of the current workflow (glass slide movement and slide review) and the experimental workflow were documented. Substantial workflow efficiencies were associated with the reduction of glass slide movement observed with the experimental workflow of the Genius system compared with the ThinPrep system.</p><p><strong>Results: </strong>The ThinPrep-based workflow required more than 5 hours of hands-on time at specific synchronized times throughout the day, whereas the hands-on time of the experimental Genius Digital Diagnostics System was just over an hour and allowed glass movement at flexible times. In addition to these workflow efficiencies, the Genius Digital Diagnostics System resulted in much shorter review times (70.1 seconds) than the ThinPrep Imaging system (138.0 seconds) while maintaining similar agreement to the sign-out diagnosis.</p><p><strong>Conclusions: </strong>This study demonstrated that implementing a Genius Dx-based workflow may result in substantial efficiency gains, which can mitigate workforce shortages and improve turnaround time without compromising screening accuracy.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}