Archives of pathology & laboratory medicine最新文献

{"title":"Inpatient Test Utilization and Test Volume Benchmarking: A Q-Probes Study.","authors":"Peter L Perrotta, Suzanne Coulter, Barbara J Blond, Thomas Long, Ron B Schifman","doi":"10.5858/arpa.2024-0104-CP","DOIUrl":"10.5858/arpa.2024-0104-CP","url":null,"abstract":"<p><strong>Context.—: </strong>Test-ordering practices vary widely between and within health care organizations, and methods used to benchmark test utilization data are unstandardized.</p><p><strong>Objective.—: </strong>To develop and apply standardized methodology to compare inpatient test utilization data submitted by laboratories enrolled in a College of American Pathologists Q-Probes study.</p><p><strong>Design.—: </strong>Participating laboratories provided inpatient test volumes for 50 designated analytes and total inpatient days for 2019 or a recent 12-month period. Test utilization patterns were characterized by studying test volumes standardized per 1000 inpatient days. Test volume variability used the standardized median absolute deviation; standardized test volumes were evaluated by calculating comparative ranges for each analyte. Standardized test volumes falling outside their respective comparative ranges are referred to as outliers in this study. Volume data were tested for association with stewardship practices and institutional demographics.</p><p><strong>Results.—: </strong>Methodology using standardized test volume data identified test groups that are commonly used in the inpatient setting and efficiently identified volume outliers. High test volume outliers included creatine kinase myocardial band, free prostate-specific antigen, myoglobin, serotonin release assay, and hepatitis B serologies; no low-volume outliers were observed. Among 33 participants, 13 (39%) had no test volume outliers, while 5 (15%) showed multiple tests (13-34) with comparatively high volumes. No statistically significant relationships were found between stewardship practices and test-ordering patterns.</p><p><strong>Conclusions.—: </strong>Our approach can be used to measure inpatient test volume data across organizations and for identifying test volumes falling outside of the standardized comparative ranges that may require interventions to change test utilization practices.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"701-708"},"PeriodicalIF":3.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741648","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":"Red Blood Cell Transfusion Practices: College of American Pathologists Q-Probes Studies of Red Blood Cell Utilization and Single and Double Red Blood Cell Unit Transfusions.","authors":"Paul F Lindholm, Rasleen K Saluja, Thomas Long, Suzanne Coulter, Barbara J Blond, Peter L Perrotta","doi":"10.5858/arpa.2024-0182-CP","DOIUrl":"10.5858/arpa.2024-0182-CP","url":null,"abstract":"<p><strong>Context.—: </strong>Opportunities to improve transfusion safety occur at lower hemoglobin (Hgb) thresholds and single-unit transfusions. Efforts to improve compliance with transfusion guidelines and single-unit transfusion practices reduce transfusions and lead to improved outcomes.</p><p><strong>Objective.—: </strong>To evaluate demographic and practice characteristics associated with lower Hgb thresholds and single red blood cell (RBC) unit transfusion practices.</p><p><strong>Design.—: </strong>This study used the College of American Pathologists (CAP) Q-Probes format with the recent 2020 and 2017 surveys of participating institutions.</p><p><strong>Results.—: </strong>High rates of transfusion review and compliance were observed with institutions reporting RBC transfusions meeting institutional guidelines. CAP inspection participants and those with a formal policy to encourage single-unit transfusions showed a trend toward greater compliance. Comparison of 2020 and 2017 survey results showed favorable downward trends in the Hgb threshold for transfusion compliance review and pretransfusion and posttransfusion Hgb values. Institutions reporting initiatives to decrease transfusions, teaching hospitals, and those with updated guidelines in alignment with recent literature reported lower pretransfusion Hgb levels in both studies. The 2020 study showed greater single-unit transfusion use among hospitals with patient blood management programs, larger institutions, and those training pathology residents. Single-unit transfusion rates varied by hospital service, with highest rates reported within hematology/oncology (99 of 138 [71.7%]), intensive care (147 of 215 [68.4%]), and medicine (419 of 666 [62.9%]) services.</p><p><strong>Conclusions.—: </strong>Transfusion practice improvement programs to decrease RBC transfusions include the use of single-unit transfusions and lower institutional pretransfusion Hgb thresholds. Opportunities to lower transfusion thresholds and increase single-unit transfusions exist in surgical and obstetrics services.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"709-716"},"PeriodicalIF":3.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678117","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 Simple Morphometric Analysis of Preoperative Therapy Response for Esophageal Adenocarcinoma.","authors":"Madhurya Ramineni, Rena X Li, Xiaoyan Liao, Yansheng Hao","doi":"10.5858/arpa.2024-0167-OA","DOIUrl":"10.5858/arpa.2024-0167-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Histologic assessment of tumor regression grade (TRG) on esophagogastrectomy specimens after neoadjuvant therapy is an excellent predictor of local recurrence rate and long-term survival in esophageal adenocarcinomas. Although several grading systems exist globally, the modified Ryan system suggested by the College of American Pathologists (CAP) is widely used in North America. Most systems rely on quantitative percentage estimation of the residual tumor with or without additional qualitative descriptors, which is relatively subjective with poor interobserver agreement.</p><p><strong>Objective.—: </strong>To test a morphometric-based approach using the microscopic objective lens to estimate the size of the largest focus of the residual tumor.</p><p><strong>Design.—: </strong>A total of 69 esophageal specimens post neoadjuvant therapy were evaluated. Tumor size was morphometrically determined by the microscopic field, using an Olympus microscope with ×10/×22 eyepieces. Residual viable tumor was categorized into 4 groups, using ×2, ×4, and ×10 objectives: ≤ ×10, > ×10 and ≤ ×4, > ×4 and < ×2, and ≥ ×2.</p><p><strong>Results.—: </strong>Morphometric measurements significantly correlated with the CAP treatment effect scores. There was no significant difference in overall survival between ≥ ×2 and ×2 to ×4 groups; however, a 3-tier system (TRG1: ≤ ×10, TRG2: > ×10 and ≤ ×4, and TRG3: > ×4) showed significant survival differences (P = .01). Significant differences in the percentage of lymphovascular and perineural invasion, advanced TNM stage, and lymph node metastasis were identified among the 3 groups.</p><p><strong>Conclusions.—: </strong>The proposed 3-tier morphometric approach based on microscopic field size is a simple and easy-to-use method, which helps stratify patients into 3 groups with distinct histopathologic features and overall survival.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"769-774"},"PeriodicalIF":3.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142815242","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":"Challenges in Consistent Histologic Diagnosis of Superficially Invasive Anal Squamous Cell Carcinoma.","authors":"Faruk Erdem Kombak, Qingqing Liu, John D Paulsen, Xintong Wang, Fatemeh Ghazanfari Amlashi, Pei Hui, Wenxin Zheng, Alexandros D Polydorides, Yuxin Liu","doi":"10.5858/arpa.2024-0463-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0463-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Superficially invasive squamous cell carcinoma of the anus (SISCCA) is defined as a minimally invasive cancer measuring less than 3 mm in depth and less than 7 mm in horizontal spread. Its subtle morphologic alterations pose a significant challenge for histologic diagnosis.</p><p><strong>Objective.—: </strong>To evaluate the diagnostic agreement among pathologists for SISCCA and to identify potential areas for improvement.</p><p><strong>Design.—: </strong>Four gastrointestinal (GI) and 4 gynecologic (GYN) pathologists independently reviewed digitized hematoxylin-eosin images of 20 anal high-grade squamous intraepithelial lesions with suspected early invasion. Participants classified each lesion as either invasive or noninvasive and selected features indicative of invasion from a list compiled from major textbooks. Cohen κ coefficient was calculated to assess interobserver agreement.</p><p><strong>Results.—: </strong>Of the 20 lesions, 8 (40%) received unanimous diagnoses, while 12 (60%) had discrepancies. Overall agreement was moderate (κ = 0.46; 95% CI, 0.29-0.48), with similar levels between the GI (κ = 0.53; 95% CI, 0.45-0.74) and GYN (κ = 0.46; 95% CI, 0.25-0.48) groups (P > .01). The GYN group diagnosed a higher number of lesions as invasive than did the GI group (median, 14.5 versus 10.5; P > .01). In consensus SISCCA diagnoses, the most commonly noted feature was the presence of small irregular tumor nests, followed by desmoplastic response and paradoxical maturation.</p><p><strong>Conclusions.—: </strong>Variability in recognizing histologic features indicative of early invasion contributed to the poor reproducibility in the diagnosis of SISCCA. Efforts should focus on refining diagnostic criteria and integrating features that have proved effective in identifying early invasive cancer at other anatomic sites.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144602456","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":"Supporting the Deceased, Their Families, and Their Communities Part 2: Practical Guidance for Building an Office of Decedent Affairs.","authors":"Meagan Chambers, Tanner Bartholow, Zachary T Parker, Kristina Peters, R Ross Reichard, Daniel J Luthringer, Charles Tigard, Jody E Hooper, Paul Benson, Ronnie Davis, Robert Cool, Ben Beglarian, Sharon Mount, Nicole R Jackson, Kathryn P Scherpelz, Desiree Marshall, John Sinard, Lisbeth Harcourt, LaTresa E Wiley, Sonja Chen, Jessica M Comstock, Courtney Hyland, Holly Harper, David Priemer, Amy Rapkiewicz, Amyn M Rojiani, Harold Sanchez","doi":"10.5858/arpa.2025-0094-OA","DOIUrl":"10.5858/arpa.2025-0094-OA","url":null,"abstract":"<p><strong>Context.—: </strong>After-death care can be complicated and time-consuming for clinical staff, and frustrating for bereaved families. Delays and errors can have damaging legal and reputational consequences for hospitals. Offices of Decedent Affairs (ODAs) have been proposed as a solution, and their potential benefits have been described in several single institution reports. The literature lacks a contemporary and comprehensive review of existing ODAs and their approaches.</p><p><strong>Objective.—: </strong>To describe the process of establishing a new ODA and to provide a snapshot of the spectrum of structure, function, and impact of existing ODAs in the United States.</p><p><strong>Design.—: </strong>A survey was administered to 11 established ODAs spread across the continental United States. Programs were identified through the College of American Pathologists Autopsy Committee and a Medical Autopsy Listserv.</p><p><strong>Results.—: </strong>Eleven ODAs returned the survey, representing more than 190 cumulative years of experience in decedent care in the hospital setting (median, 10 years). There was a wide range in staffing (both staff size and background) as well as scope of services offered. The median ratio of hospital deaths to full-time equivalent (FTE) staffing was 360 deaths per FTE. Respondents report that ODAs unburden clinical providers and facilitate decedent management. Some respondents report a quicker turnover of hospital beds and shorter intervals between pronouncement of death and autopsy. ODAs increased autopsy rates when the autopsy services were part of the ODA.</p><p><strong>Conclusions.—: </strong>This survey provides practical information for hospitals considering establishing a new ODA and useful benchmarks for existing ODA programs.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585869","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":"Infantile Pyknocytosis Revisited: Possible Familial Trend in a Study of 9 Patients.","authors":"Aileen Y Hu, Amy M Coffey, Jyotinder N Punia, Andrea N Marcogliese, Choladda V Curry, M Tarek Elghetany","doi":"10.5858/arpa.2024-0504-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0504-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Infantile pyknocytosis (IP) is an uncommon cause of transient neonatal hemolytic anemia and hyperbilirubinemia occurring in approximately 10% of cases of unexplained neonatal hemolytic anemia.</p><p><strong>Objective.—: </strong>To study cases of IP with focus on long-term follow-up, perinatal events, and family history.</p><p><strong>Design.—: </strong>Cases were prospectively identified during review of peripheral blood smears for neonatal hyperbilirubinemia during an 11-year period. Clinical and laboratory parameters, follow-up data, and family history were recorded.</p><p><strong>Results.—: </strong>Nine cases of IP were identified from the morphologic recognition of pyknocytes and clinical and laboratory evidence of hemolysis, and included 6 males and 3 females. Age at diagnosis ranged from 1 to 18 days (median, 4 days), and gestational age at birth ranged from 29 to 38 weeks (median, 35 weeks). Hemoglobin nadir ranged from 4.9 to 8.1 g/dL (median, 6 g/dL), and maximum total bilirubin concentration ranged from 7.7 to 27.5 mg/dL (median, 22.0 mg/dL). All 9 patients required phototherapy and transfusions. Hemolysis spontaneously resolved without recurrence in all cases, with time to resolution ranging from 13 to 70 days (median, 33 days) and median follow-up of 7 years (range, 1-11 years). Six patients (67%) had a sibling with neonatal jaundice as well. A similar proportion had significant perinatal events.</p><p><strong>Conclusions.—: </strong>IP is associated with spontaneous resolution without long-term complications. The underlying etiology is unknown. Perinatal events may expose red blood cells to an overwhelming oxidative stress. Strong family history suggests familial predisposition causing transient red blood cell defect, making them more susceptible to hemolysis.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585867","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":"Supporting the Deceased, Their Families, and Their Communities Part 1: Why Establish an Office of Decedent Affairs.","authors":"Meagan Chambers, Tanner Bartholow, Zachary T Parker, Kristina Peters, R Ross Reichard, Daniel J Luthringer, Charles Tigard, Jody E Hooper, Paul Benson, Ronnie Davis, Robert Cool, Ben Beglarian, Sharon Mount, Nicole R Jackson, Kathryn P Scherpelz, Desiree Marshall, John Sinard, Lisbeth Harcourt, LaTresa E Wiley, Sonja Chen, Jessica M Comstock, Courtney Hyland, Holly Harper, David Priemer, Amy Rapkiewicz, Amyn M Rojiani, Harold Sanchez","doi":"10.5858/arpa.2025-0090-OA","DOIUrl":"10.5858/arpa.2025-0090-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Decedent Affairs Offices and Programs can serve as an avenue to assist medical centers in facilitating efficient and comprehensive decedent management, despite a paucity of literature on their roles, establishment, and efficacy.</p><p><strong>Objective.—: </strong>To characterize the motivations and rationales for establishing Decedent Affairs Offices.</p><p><strong>Design.—: </strong>A survey was administered to 11 established Decedent Affairs Offices/Programs, identified through the College of American Pathologists Autopsy Committee and a Medical Autopsy Listserv. The questions comprehensively cover establishment, operations, and outcomes data available by institution.</p><p><strong>Results.—: </strong>Survey respondents report the rationale for starting their programs, and the benefits such offices can have.</p><p><strong>Conclusions.—: </strong>Decedent Affairs Offices and Programs provide a useful option to medical centers to navigate the increasingly complex task of comprehensive decedent management. The present survey helps to delineate the similarities and differences between these programs at 11 institutions, to aid nascent programs in their establishment and growth over time.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585868","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":"College of American Pathologists Foundation Global Pathology Committee: Working to Expand Health Equity and Learning Globally.","authors":"Gail H Vance, Julia A Rankenburg","doi":"10.5858/arpa.2024-0272-ED","DOIUrl":"10.5858/arpa.2024-0272-ED","url":null,"abstract":"","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":"149 7","pages":"595-596"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144487426","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":"Gestational Choriocarcinoma: A Timely Review of Diagnostic Pathology.","authors":"Pei Hui","doi":"10.5858/arpa.2025-0156-RA","DOIUrl":"https://doi.org/10.5858/arpa.2025-0156-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Gestational choriocarcinoma is the most common form of gestational trophoblastic neoplasm. It is characterized by aggressive, destructive growth and a marked tendency for hematogenous spread, leading to high mortality if left untreated. However, with the advent of effective clinical treatment for postmolar gestational trophoblastic neoplasms in recent decades, the clinicopathologic presentation of gestational choriocarcinoma has significantly changed. Today, it more frequently presents at extrauterine sites and/or in an unexpected manner, posing considerable diagnostic challenges for pathologists. Nonetheless, prompt and accurate pathologic diagnosis remains essential for effective clinical management and optimal patient outcomes.</p><p><strong>Objective.—: </strong>To review the clinical features and pathologic diagnosis of gestational choriocarcinoma, including its early manifestations.</p><p><strong>Data sources.—: </strong>This review is based on literature and the author's personal diagnostic experience.</p><p><strong>Conclusions.—: </strong>In the era of precision medicine, gestational choriocarcinoma has become a rare encounter, largely owing to the implementation of postmolar surveillance programs and timely initiation of chemotherapy. Diagnostic recognition of the tumor requires a high index of suspicion, familiarity with its histologic features and early forms, awareness of the unexpected extrauterine presentations, and appropriate use of immunohistochemical and molecular biomarkers. These tools are essential in distinguishing gestational choriocarcinoma from nongestational mimics of germ cell or somatic origin, which have a profound therapeutic and prognostic implications.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144531559","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":"Filling in the Gaps of Examining Human Epidermal Growth Factor Receptor 2 (HER2)-Low and HER2-Ultralow in Breast Cancer: Clone Choice, Sample Size, and Reevaluating Scores Made on Archived Samples.","authors":"Emad Alqassim, Sayeeda Yasmeen, John Etter, Thaer Khoury","doi":"10.5858/arpa.2024-0334-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0334-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Human epidermal growth factor receptor 2 (HER2)-low breast carcinoma is a clinical entity that has targeted therapy.</p><p><strong>Objectives.—: </strong>To evaluate the effect of antibody clone/sample size on HER2 status and reinterpret archived HER2-stained slides following current guidelines.</p><p><strong>Design.—: </strong>We collected 86 estrogen-receptor+/HER2- breast carcinoma core needle biopsy (CNB) samples with archived slides stained with HER2 (HercepTest) and for Oncotype DX (ODX) assay. These slides were scored by 3 pathologists (consensus score) and then compared to the reported scores. The CNB and excisional biopsy (EB) samples were stained with 4B5. We performed a 3-way comparison between CNB-4B5, CNB-HercepTest, and EB-4B5. The mRNA values were abstracted from the ODX report. The mRNA values were compared with the EB-4B5 scores (semiquantitative [H-score] and categorical [zero, 1+, and 2+] system), the consensus score of CNB-HercepTest, and then with the consensus scores of CNB-4B5.</p><p><strong>Results.—: </strong>Upon rescoring the archived CNB-HercepTest slides, 45.3% were discordant; 12 of 19 (63.2%) reported as 1+ were HER2-zero. The discordance rate between CNB-4B5 and EB-4B5 was 24.4%; between CNB-4B5 and CNB-HercepTest, 59.3%; and between CNB-HercepTest and EB-4B5, 62.8%. The mRNA values correlated with EB-4B5 when using the H-score (P = .003) or the categorical system (zero, 1+, 2+) (P = .008), and with CNB-4B5 (P = .002), but did not correlate with CNB-HercepTest.</p><p><strong>Conclusions.—: </strong>The discordance of HER2 staining depended on the sample size and antibody clone. Tissue stained with 4B5 (CNB or EB), but not with CNB-HercepTest, correlated with mRNA values.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144512919","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}