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The Impact of Pathologist Review on Peripheral Blood Smears: A College of American Pathologists Q-Probes Study of 22 Laboratories. 病理学家审查对外周血涂片的影响:美国病理学家学会对 22 个实验室进行的 Q-Probes 研究。
Archives of pathology & laboratory medicine Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0117-CP
Megan O Nakashima, Suzanne Nelson Coulter, Barbara J Blond, Richard W Brown, Jeffrey A Vos
{"title":"The Impact of Pathologist Review on Peripheral Blood Smears: A College of American Pathologists Q-Probes Study of 22 Laboratories.","authors":"Megan O Nakashima, Suzanne Nelson Coulter, Barbara J Blond, Richard W Brown, Jeffrey A Vos","doi":"10.5858/arpa.2024-0117-CP","DOIUrl":"https://doi.org/10.5858/arpa.2024-0117-CP","url":null,"abstract":"<p><strong>Context.—: </strong>The aim of the study was to determine the impact of peripheral blood (PB) smear review by a pathologist when requested by a technologist or provider to measure the rate of pathologist-detected clinically relevant findings.</p><p><strong>Objective.—: </strong>To report and analyze the results of clinically relevant morphologic findings on PB smears that were pathologist reviewed because of either a request from a technologist or an order from a provider.</p><p><strong>Design.—: </strong>During a 4-week study period, participants enrolled in the College of American Pathologists Q-Probes program submitted data on PB smear reviews including review request source, reason for review request, and if the pathologist's review resulted in a clinically relevant morphologic finding.</p><p><strong>Results.—: </strong>Twenty-two institutions submitted data on 835 eligible PB smears. Pathologists identified clinically relevant findings on a median 53.4% of technologist-requested PB smear reviews and a median 14.3% of provider-ordered PB smear reviews .The most frequently identified pathologist finding on technologist-requested PB smear reviews was \"blasts\" in 91 of 532 (17.1%) followed by \"atypical (possibly neoplastic) lymphocytes\" in 74 of 532 (13.9%); the most frequent finding on provider-ordered reviews was \"other\" in 55 of 315 (17.5%) followed by \"immature cells/left shift in myeloid cells or monocytes\" in 12 of 315 (3.8%). Pathologists agreed with technologists' indications for review in 458 of 513 requested reviews (89.3%). Institutions that conducted postanalytic follow-up on previously reviewed PB smears had a higher rate of clinically relevant findings detected on technologist-requested smears.</p><p><strong>Conclusions.—: </strong>Pathologist review of PB smears flagged by technologists for review frequently yielded clinically relevant findings. This was higher in institutions that conducted postanalytic reviews. Provider-ordered reviews resulted in clinically relevant findings in a median of 14.3% of smears.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634264","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
Pathologists Providing Direct Patient Care in Thoracic Transplant: Same Objective, Different Scope. 病理学家在胸腔移植手术中直接为患者提供护理:目标相同,范围不同。
Archives of pathology & laboratory medicine Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0226-OA
Melanie C Bois, Marie-Christine Aubry, Anja C Roden, Jennifer M Boland, Diane M Meyer, Rachel K Askelson, Kevin M Praska, Alfredo Clavell, Cassie Kennedy, John P Scott, Rebecca K Ameduri, Jonathan M Morris, Ying-Chun Lo, Nicole L Larson, Kelsey L Ness, Kally M Gleichner, Kristina Peters, Andrew J Layman, Eunhee S Yi, Joseph J Maleszewski
{"title":"Pathologists Providing Direct Patient Care in Thoracic Transplant: Same Objective, Different Scope.","authors":"Melanie C Bois, Marie-Christine Aubry, Anja C Roden, Jennifer M Boland, Diane M Meyer, Rachel K Askelson, Kevin M Praska, Alfredo Clavell, Cassie Kennedy, John P Scott, Rebecca K Ameduri, Jonathan M Morris, Ying-Chun Lo, Nicole L Larson, Kelsey L Ness, Kally M Gleichner, Kristina Peters, Andrew J Layman, Eunhee S Yi, Joseph J Maleszewski","doi":"10.5858/arpa.2024-0226-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0226-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Cardiac and pulmonary allograft recipients represent a unique population, frequently interacting with support groups and exhibiting intense curiosity about their pathology. Like other solid organ transplant patients, they have enduring and frequent interaction with the laboratory for routine allograft surveillance.</p><p><strong>Objective.—: </strong>To address patient requests to understand what happens to their explanted organ and to better understand their disease while simultaneously improving awareness of pathologists' role in their continuing care.</p><p><strong>Design.—: </strong>At routine follow-up appointments, transplant nurse coordinators offer each allograft recipient the opportunity to interact with a pathologist in our \"On My Path\" program. Organ viewing occurs in a private setting, in a specialized room. Relevant pathology is discussed, and questions are answered, with documentation in the medical record. The patient is subsequently gifted a 3-dimensional model of their explanted organ. Transplant coordinators were surveyed for their feedback on the experience.</p><p><strong>Results.—: </strong>One hundred fifty-eight interactions have been documented (2017-2022), including patients who underwent cardiac transplant (96, 61%), single or bilateral lung transplant (54, 34%), or combination lung and heart transplant (8, 5%). Transplant coordinators reported an increase in patient understanding of their disease and emotional closure related to the disease through the On My Path program.</p><p><strong>Conclusions.—: </strong>Pathologists providing direct patient care is a feasible model that addresses currently unmet desires of the transplant population to better understand their pathology. Providing a 3-dimensional model helps to empower patients and drives satisfaction. These interactions also improve awareness about pathology as a discipline and its importance in the continued care of transplant recipients.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634181","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
Lymphangioleiomyomatosis: A Review. 淋巴管瘤病:综述。
Archives of pathology & laboratory medicine Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0206-RA
Mohammed Amine Bouanzoul, Yale Rosen
{"title":"Lymphangioleiomyomatosis: A Review.","authors":"Mohammed Amine Bouanzoul, Yale Rosen","doi":"10.5858/arpa.2024-0206-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0206-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Lymphangioleiomyomatosis is a rare multisystem disorder belonging to the family of neoplasms exhibiting perivascular epithelioid differentiation. It primarily affects women of childbearing age. The disease is characterized by a proliferation of smooth muscle-like cells (lymphangioleiomyomatosis cells) within all lung compartments, leading to cystic parenchymal destruction and, in some cases, respiratory failure. These cells carry mutations in one or both tuberous sclerosis (TSC) genes and coexpress smooth muscle and melanocytic markers. Female hormones, particularly estrogens, influence the course of the disease. Symptoms of lymphangioleiomyomatosis vary significantly among patients, ranging from exertional dyspnea and coughing to chest pain and recurrent pneumothorax.</p><p><strong>Objective.—: </strong>To present the latest advancements in the understanding of disease pathogenesis and diagnosis, illustrate the pathologic and radiologic findings, provide a reference for pathologists and other health care professionals, briefly discuss recent evidence-based therapeutic approaches, and emphasize the importance of adopting a multidisciplinary approach to diagnosis and optimization of patient care.</p><p><strong>Data sources.—: </strong>A comprehensive review of pertinent medical literature published in the last 30 years, focusing on publications written in the English language, was performed.</p><p><strong>Conclusions.—: </strong>Despite the recent significant advancements in the understanding and management of lymphangioleiomyomatosis, there are still significant gaps in our knowledge of its pathophysiology and the role of the immune system in the genesis and progression of the disease. The current changes in diagnostic algorithms favor the adoption of minimally invasive procedures as the standard of care. As a result, the clinical laboratory will play a larger role in the diagnosis of lymphangioleiomyomatosis, and surgical pathologists will likely be less involved in the diagnosis of pulmonary lymphangioleiomyomatosis than they currently are.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634057","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
Exploring the Incidence of Testicular Neoplasms in the Transgender Population: A Case Series. 探索变性人睾丸肿瘤的发病率:病例系列。
Archives of pathology & laboratory medicine Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0218-OA
Elayna M Shanker, Qinghu Ren, Lee C Zhao, Rachel Bluebond-Langner, Fang-Ming Deng
{"title":"Exploring the Incidence of Testicular Neoplasms in the Transgender Population: A Case Series.","authors":"Elayna M Shanker, Qinghu Ren, Lee C Zhao, Rachel Bluebond-Langner, Fang-Ming Deng","doi":"10.5858/arpa.2024-0218-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0218-OA","url":null,"abstract":"<p><strong>Context.—: </strong>The use of hormonal therapy and gender-affirming surgery in the transgender community has been rising during the last several years. Although it is generally safe, hormonal therapy's link to testicular cancer remains uncertain.</p><p><strong>Objective.—: </strong>To review the incidence of testicular cancer in specimens from gender-affirming orchiectomies at our institution and evaluate the tumors for histologic and genetic alterations.</p><p><strong>Design.—: </strong>Pathology reports for gender-affirming orchiectomies (January 1, 2018, to August 1, 2023) were reviewed for testicular neoplasms, with additional analysis for chromosome 12 abnormalities. Incidence and chromosome variations were compared with those in the general population.</p><p><strong>Results.—: </strong>Among 458 cases during 5.5 years, 5 germ cell neoplasms in 4 patients emerged. Our institution's annual incidence rate (159 per 100 000) is 26.5 times higher than the National Cancer Institute's previous report (6.0 per 100 000). Although they were morphologically no different from germ cell neoplasms in the general population, fluorescence in situ hybridization tests showed no i(12p) in 4 of 5 neoplasms (80%) in our cohort.</p><p><strong>Conclusions.—: </strong>The cause behind this rise in incidence remains uncertain but may be due to long term pretreatment with hormones or blockers. The lower isochromosome 12p frequency suggests an alternative mechanism driving tumor development, which requires more detailed molecular studies.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634116","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
Global Pathology: A Snapshot of the Problems, the Progress, and the Potential. 全球病理学:问题、进展和潜力掠影》。
Archives of pathology & laboratory medicine Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0183-RA
Andria Chada, Aisha Jibril Suleiman, Zewditu Chanyalew, Lewis Hassell, Bereket Berhane Woldeab, Giorgis Yeabo, Dana Razzano
{"title":"Global Pathology: A Snapshot of the Problems, the Progress, and the Potential.","authors":"Andria Chada, Aisha Jibril Suleiman, Zewditu Chanyalew, Lewis Hassell, Bereket Berhane Woldeab, Giorgis Yeabo, Dana Razzano","doi":"10.5858/arpa.2024-0183-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0183-RA","url":null,"abstract":"<p><strong>Context.—: </strong>For equitable global health care, the United Nations has outlined Sustainable Development Goals for health in low-income and middle-income countries (LMICs) with the goal of reaching universal health care by 2030. Currently, 47% of the global population lacks access to basic diagnostics for many common diseases. The need for diagnostic access has never been more critical owing to the dramatic rise of noncommunicable diseases in LMICS. In a recent analysis, The Lancet Commission on Diagnostics estimated that 1.1 million deaths occurring on an annual basis could be avoided if the diagnostic gap were reduced to 10% for only 6 priority conditions.</p><p><strong>Objective.—: </strong>To provide a nonexhaustive summary of the progress made to overcome the barriers to adequate access and explore the potential solutions needed to achieve global diagnostic equity.</p><p><strong>Data sources.—: </strong>Several experts in global pathology were interviewed in addition to pathologists working in low-resource settings outside of the United States. Published literature on the topic of global pathology work was analyzed and summarized to provide a cohesive snapshot of the status of global pathology.</p><p><strong>Conclusions.—: </strong>Working to increase access to diagnostics in low-resource settings will save millions of lives. The solution to the current inadequate availability of global pathology services will require a global commitment from the entire pathology and laboratory medicine community, government support, and collaboration between the public-private sectors to achieve equitable health care.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634123","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
Adherence to Synoptic Cancer Pathology Reporting Among Pathologists in the National Department of Veterans Affairs Health Care System. 国家退伍军人事务部医疗保健系统病理学家对癌症病理同步报告的遵守情况。
Archives of pathology & laboratory medicine Pub Date : 2024-11-08 DOI: 10.5858/arpa.2024-0229-OA
Abdol Aziz Ould Ismail, Soham Kale, Kathryn McGonagle, Brent Hill, Jason R Pettus, Scott L DuVall, Jeffrey P Ferraro, Florian R Schroeck
{"title":"Adherence to Synoptic Cancer Pathology Reporting Among Pathologists in the National Department of Veterans Affairs Health Care System.","authors":"Abdol Aziz Ould Ismail, Soham Kale, Kathryn McGonagle, Brent Hill, Jason R Pettus, Scott L DuVall, Jeffrey P Ferraro, Florian R Schroeck","doi":"10.5858/arpa.2024-0229-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0229-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Quality communication between clinicians and pathologists is required for optimal cancer care. The College of American Pathologists provides anatomic site-specific cancer protocols that facilitate synoptic reporting for efficient communication, contributing to accuracy and completeness of cancer staging.</p><p><strong>Objective.—: </strong>To evaluate synoptic cancer pathology reporting across the Department of Veterans Affairs (VA), the largest integrated health system in the United States, for 4 common cancers: melanoma and colon, bladder, and kidney cancer.</p><p><strong>Design.—: </strong>For each cancer type, we investigated at least 200 biopsy and 200 resection reports from 2019 to 2021. In each report, we determined whether a synoptic format was used. The reports were selected using random sampling across all VA health care facilities. We also identified a set of core elements that were underdocumented.</p><p><strong>Results.—: </strong>Among 1618 pathology reports, 778 (48%; 95% CI, 46%-50%) were synoptic reports. Synoptic reporting was much more common among resections (621 of 811; 77%; 95% CI, 74%-79%) than among biopsies (157 of 807; 19%; 95% CI, 17%-22%). It was most common in colorectal resections (200 of 206; 97%; 95% CI, 94%-99%) and least common in colon biopsy reports (1 of 200; 0.5%; 95% CI, 0%-3%). Core elements that were underdocumented included procedure and regional lymph nodes for resections of bladder and kidney cancer and of melanoma.</p><p><strong>Conclusions.—: </strong>Synoptic reporting was used about three-quarters of the time for resections and about 1 in 5 times for biopsies. Future work should develop implementation strategies to improve synoptic reporting, especially for biopsy specimens and core elements that were relatively underdocumented.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142606937","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
Correlation of Serum Galactose-Deficient IgA1 and Oxford Class in Cases of IgA Nephropathy. IgA 肾病病例血清缺失半乳糖 IgA1 与牛津分级的相关性
Archives of pathology & laboratory medicine Pub Date : 2024-11-01 DOI: 10.5858/arpa.2023-0190-OA
Monika Shukla, Kiran Preet Malhotra, Abhilash Chandra, Namrata Sarvepalli Rao, Mohammad Kaleem Ahmad
{"title":"Correlation of Serum Galactose-Deficient IgA1 and Oxford Class in Cases of IgA Nephropathy.","authors":"Monika Shukla, Kiran Preet Malhotra, Abhilash Chandra, Namrata Sarvepalli Rao, Mohammad Kaleem Ahmad","doi":"10.5858/arpa.2023-0190-OA","DOIUrl":"10.5858/arpa.2023-0190-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Galactose-deficient immunoglobulin A1 (Gd-IgA1) deposition in the renal mesangium plays a role in the pathogenesis of IgA nephropathy.</p><p><strong>Objective.—: </strong>To assess the serum Gd-IgA1 level in biopsy-proven IgA nephropathy cases at diagnosis and 3 months post treatment and its relation with histologic Oxford classification.</p><p><strong>Design.—: </strong>In this hospital-based prospective cohort study, 40 cases and 20 controls were enrolled. Serum samples of biopsy-proven IgA nephropathy cases collected on the day of biopsy and 3 months post treatment were evaluated. Solid-phase ELISA (enzyme-linked immunosorbent assay) was performed for assessment of Gd-IgA1 level. All renal biopsies were scored by using the Oxford classification (C-MEST score). The association of serum Gd-IgA1 levels with other established prognostic parameters was assessed. To estimate the prognostic value of markers, logistic regression analysis and Kruskal-Wallis ANOVA (analysis of variance) were used.</p><p><strong>Results.—: </strong>A significant difference was observed in the serum Gd-IgA1 level values in the IgA nephropathy cases and healthy controls (P = .001) at baseline. However, no significant correlation between serum Gd-IgA1 levels at baseline and 3 months of follow-up (P = .31) or between baseline levels and age, proteinuria, hematuria, or estimated glomerular filtration rate was noted. There was no significant correlation between C-MEST score and serum Gd-IgA1 levels at baseline (P > .05); however, the distribution of Gd-IgA1 at 3 months was found to differ significantly between different grades of S score (P = .008).</p><p><strong>Conclusions.—: </strong>Serum Gd-IgA1 levels may be of utility in predicting disease progression in IgA nephropathy cases. Measurement of serum Gd-IgA1 levels for the diagnosis and prognosis of IgA nephropathy may preclude the need for invasive renal biopsies.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139577125","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
Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine. 开发米韦妥昔单抗索拉坦星的 FRα 辅助诊断免疫组化测定。
Archives of pathology & laboratory medicine Pub Date : 2024-11-01 DOI: 10.5858/arpa.2023-0149-OA
Racheal L James, Taryn Sisserson, Zhuangyu Cai, Megan E Dumas, Landon J Inge, James Ranger-Moore, Albert Mason, Callum M Sloss, Katherine McArthur
{"title":"Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine.","authors":"Racheal L James, Taryn Sisserson, Zhuangyu Cai, Megan E Dumas, Landon J Inge, James Ranger-Moore, Albert Mason, Callum M Sloss, Katherine McArthur","doi":"10.5858/arpa.2023-0149-OA","DOIUrl":"10.5858/arpa.2023-0149-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Folate receptor-α (FRα, encoded by the FOLR1 gene) is overexpressed in several solid tumor types, including epithelial ovarian cancer (EOC), making it an attractive biomarker and target for FRα-based therapy in ovarian cancer.</p><p><strong>Objective.—: </strong>To describe the development, analytic verification, and clinical performance of the VENTANA FOLR1 Assay (Ventana Medical Systems Inc) in EOC.</p><p><strong>Design.—: </strong>We used industry standard studies to establish the analytic verification of the VENTANA FOLR1 Assay. Furthermore, the VENTANA FOLR1 Assay was used in the ImmunoGen Inc-sponsored SORAYA study to select patients for treatment with mirvetuximab soravtansine (MIRV) in platinum-resistant EOC.</p><p><strong>Results.—: </strong>The VENTANA FOLR1 Assay is highly reproducible, demonstrated by a greater than 98% overall percent agreement (OPA) for repeatability and intermediate precision studies, greater than 93% OPA for interreader and greater than 96% for intrareader studies, and greater than 90% OPA across all observations in the interlaboratory reproducibility study. The performance of the VENTANA FOLR1 Assay in the SORAYA study was evaluated by the overall staining acceptability rate, which was calculated using the number of patient specimens that were tested with the VENTANA FOLR1 Assay that had an evaluable result. In the SORAYA trial, data in patients who received MIRV demonstrated clinically meaningful efficacy, and the overall staining acceptability rate of the assay was 98.4%, demonstrating that the VENTANA FOLR1 Assay is safe and effective for selecting patients who may benefit from MIRV. Together, these data showed that the assay is highly reliable, consistently producing evaluable results in the clinical setting.</p><p><strong>Conclusions.—: </strong>The VENTANA FOLR1 Assay is a robust and reproducible assay for detecting FRα expression and identifying a patient population that derived clinically meaningful benefit from MIRV in the SORAYA study.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572338","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
A Comparison Between Immunohistochemistry and mRNA Expression to Identify Human Epidermal Growth Factor Receptor 2-Low Breast Cancer. 免疫组织化学与 mRNA 表达的比较,以鉴别人类表皮生长因子受体 2 低水平乳腺癌。
Archives of pathology & laboratory medicine Pub Date : 2024-10-30 DOI: 10.5858/arpa.2024-0255-OA
Ximena Baez-Navarro, Mieke R van Bockstal, Angelique van der Made, Carolien H M van Deurzen
{"title":"A Comparison Between Immunohistochemistry and mRNA Expression to Identify Human Epidermal Growth Factor Receptor 2-Low Breast Cancer.","authors":"Ximena Baez-Navarro, Mieke R van Bockstal, Angelique van der Made, Carolien H M van Deurzen","doi":"10.5858/arpa.2024-0255-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0255-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Breast cancers (BCs) with low levels of human epidermal growth factor receptor 2 (HER2) expression (HER2-low) have become a targetable subset because of novel antibody-drug conjugates. HER2 immunohistochemistry (IHC) is the recommended assay for HER2 classification but is associated with limited interobserver agreement concerning HER2-low identification.</p><p><strong>Objective.—: </strong>To investigate whether mRNA expression quantified via quantitative reverse transcription-polymerase chain reaction (RT-qPCR) could serve as a valuable complementary and more objective method to identify HER2-low BCs.</p><p><strong>Design.—: </strong>We selected all cases from a previously published interobserver study, which included 105 needle biopsies from HER2 nonamplified BC cases. HER2 IHC was evaluated by 16 pathologists. For the current study, mRNA was extracted from microdissected invasive tumor cells. RT-qPCR was performed for quantitative evaluation of HER2, using the cutoff values of the MammaTyper assay. We compared the mRNA expression levels with the IHC scores of the majority agreement (IHC 0, IHC >0, <1+ [ultralow], 1+, 2+) and the following HER2 subcategories: HER2 0/ultralow and HER2-low (IHC 1+ and 2+/fluorescence in situ hybridization negative).</p><p><strong>Results.—: </strong>In total, 88 nonamplified HER2 cases could be analyzed. Based on IHC, 17 cases were HER2 0/ultralow and 71 were HER2-low. The mean rank HER2 mRNA level was significantly higher in HER2-low cases than in the HER2 0/ultralow group (P < .001). However, 10 of 17 HER2 0/ultralow cases by IHC (58.8%) were classified as HER2-low by MammaTyper, 2 of 71 cases (2.8%) were HER2-low by IHC and HER2 0/ultralow by MammaTyper, and 2 (2.8%) were HER2-low by IHC and HER2-positive by RP-qPCR.</p><p><strong>Conclusions.—: </strong>Our findings indicate a strong agreement between mRNA expression quantified by RT-qPCR and HER2 IHC scores, although there was a substantial proportion of discordant HER2 results between both methods owing to overestimation of HER2 expression by MammaTyper compared to IHC. Future large-scale trials should determine which technique is best associated with clinical outcome.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549502","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
Artificial Intelligence-Assisted Daily Quality Control System for the Histologic Diagnosis of Gastrointestinal Endoscopic Biopsies: A 1-Year Experience. 人工智能辅助胃肠道内窥镜活检组织学诊断日常质量控制系统:一年的经验。
Archives of pathology & laboratory medicine Pub Date : 2024-10-25 DOI: 10.5858/arpa.2024-0173-OA
Seung-Yeon Yoo, Yuri Hwang, Seokju Yun, Ok Hee Lee, Jiwook Jang, Youngjin Park, Tae Young Cho, Young Sin Ko
{"title":"Artificial Intelligence-Assisted Daily Quality Control System for the Histologic Diagnosis of Gastrointestinal Endoscopic Biopsies: A 1-Year Experience.","authors":"Seung-Yeon Yoo, Yuri Hwang, Seokju Yun, Ok Hee Lee, Jiwook Jang, Youngjin Park, Tae Young Cho, Young Sin Ko","doi":"10.5858/arpa.2024-0173-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0173-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Seegene Medical Foundation, one of the major clinical laboratories in South Korea, developed SeeDP, an artificial intelligence (AI)-based postanalytic daily quality control (QC) system that reassesses all gastrointestinal (GI) endoscopic biopsy (EB) slides for incorrect diagnoses.</p><p><strong>Objective.—: </strong>To review the operational records and clinical impact of SeeDP since its launch in March 2022.</p><p><strong>Design.—: </strong>Operational records of SeeDP were retrieved for the period of March 1, 2022, to February 28, 2023. Among cases scanned during 40 working days (March 10, 2022, to May 4, 2022), all discordant cases encountered by 2 pathologists were reviewed. Cases of SeeDP-assisted revised diagnoses were collected and compared with cases recognized using conventional methods.</p><p><strong>Results.—: </strong>Occasional scanner failures and various types of aberrant errors compromised QC coverage, resulting in the scanning of only 67.7% (572 254 of 844 906) of all EB slides submitted and 0.8% of the scanned slides being further excluded from the AI analysis. The AI predictions differed from the pathologists' diagnoses in 42 760 of the 557 672 gastrointestinal EB slides (7.7%) successfully assessed by the AI models; however, a detailed review of discordant slides revealed that true misdiagnosis accounted for only 5.5% (25 of 454) of the disagreements. Compared with conventional error recognition methods, SeeDP detected more misdiagnoses (7 versus 14) within a significantly shorter time (average, 3.6 versus 38.7 days; P < .001), including 1 signet ring cell carcinoma initially diagnosed as gastritis.</p><p><strong>Conclusions.—: </strong>AI-based daily QC systems are plausible solutions to guarantee high-quality pathologic diagnosis by enabling rapid detection and correction of misdiagnosis.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514517","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}
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