American journal of clinical pathology最新文献

{"title":"CEACAM1 expression by immunohistochemistry in B-cell lymphomas and plasma cell myeloma.","authors":"V Rakesh Sethapati, Vu Ngo, Alexey Danilov, Tycel Phillips, Geoffrey Shouse, Alex Herrera, Anamarija M Perry, Aimin Li, Larry Kwak, Dennis D Weisenburger, Wing C Chan, Joo Y Song","doi":"10.1093/ajcp/aqag078","DOIUrl":"10.1093/ajcp/aqag078","url":null,"abstract":"<p><strong>Objectives: </strong>Mantle cell lymphoma (MCL) is an aggressive B-cell lymphoma with limited curative treatment options. Carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1) has recently been implicated in B-cell receptor signaling in MCL. We evaluated CEACAM1 expression by immunohistochemistry across MCL and other mature B-cell neoplasms, including small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM).</p><p><strong>Methods: </strong>We retrospectively analyzed 164 lymphoma cases, 35 MM cases, and 2 plasmacytomas. CEACAM1 expression was assessed on tissue microarrays by immunohistochemistry and scored using a prespecified dichotomous cutoff. In DLBCL, CEACAM1 status was correlated with cell-of-origin classification and targeted mutational data.</p><p><strong>Results: </strong>CEACAM1 was expressed in 27 of 30 MCL cases (90%), higher than in the other lymphoma subtypes combined (35%; P < .0001). Expression was also seen in SLL (20/30, 67%), MM (23/35, 66%), MZL (8/22, 36%), and DLBCL (19/82, 23%). In DLBCL, expression was more frequent in germinal center B-cell subtype than activated B-cell subtype cases (30% vs 13%; P = .023). Within sequenced DLBCL cases, CEACAM1 expression was associated with BCL2 and TNFRSF14 mutations. In MM, CEACAM1 expression was not significantly associated with recurrent cytogenetic abnormalities, although a nonsignificant trend toward higher expression in t(11;14) cases (75% vs 53%, Fisher exact P = .28).</p><p><strong>Conclusions: </strong>CEACAM1 is frequently expressed in MCL and in subsets of other mature B-cell neoplasms and MM. These findings support further investigation of CEACAM1 as a biologically relevant marker and potential therapeutic target in selected lymphoid malignancies.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13312280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148343759","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":"Clinicopathologic features of systemic ALK-negative anaplastic large cell lymphoma with TP53 deletion.","authors":"Wei J Wang, Guilin Tang, L Jeffrey Medeiros, Shaoying Li, Pei Lin, Sa A Wang, Wei Wang, Joseph D Khoury, Sanam Loghavi, Swaminathan P Iyer, Luis Malpica, Lianqun Qiu, Hong Fang, Qing Wei, Wen Shuai, Francisco Vega, Jie Xu","doi":"10.1093/ajcp/aqag036","DOIUrl":"10.1093/ajcp/aqag036","url":null,"abstract":"<p><strong>Objectives: </strong>In this study, we illustrated the significance of TP53 deletion (D) in systemic ALK-negative anaplastic large cell lymphoma (ALCL), an area that remains unknown.</p><p><strong>Methods: </strong>We evaluated TP53-D by fluorescence in situ hybridization in 66 patients with systemic ALK-negative ALCL and compared the results with clinicopathologic features.</p><p><strong>Results: </strong>TP53-D was identified in 32 (48%) cases. Peripheral blood involvement occurred exclusively in the TP53-D group compared with the TP53-not deleted (ND) group (50% vs 0%, P = .01). TP53-D cases more frequently showed p53 overexpression by immunohistochemistry than TP53-ND cases (P = .03). Among the International Prognostic Index (IPI) score, TP53-D, DUSP22 rearrangement (DUSP22-R), and stem cell transplantation status, for the entire cohort, only a low IPI score (<3) was associated with superior overall survival (P = .04), while none of these factors affected progression-free survival (PFS). In TP53-ND patients, low IPI and DUSP22-R were associated with significantly longer PFS (P = .04 and P = .02); these associations were absent in TP53-D patients.</p><p><strong>Conclusions: </strong>TP53-D is common in systemic ALK-negative ALCL and is associated with leukemic disease and p53 overexpression. TP53-D did not directly affect survival, but it negated the favorable impact of low IPI and DUSP22-R on PFS, suggesting its potential value as an adverse prognostic marker.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148161437","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":"Development and validation of a quantitative ultra-performance liquid chromatography quadrupole time-of-flight method for urine organic acid analysis.","authors":"Yi Xiao, Michael Wakefield, Mari Ishak Gabra, Lidong Zhai, Edward Ki Yun Leung","doi":"10.1093/ajcp/aqag061","DOIUrl":"10.1093/ajcp/aqag061","url":null,"abstract":"<p><strong>Objectives: </strong>Urine organic acid analysis is essential for diagnosing inborn errors of metabolism and is conventionally performed using multistep, labor-intensive sample preparation and gas chromatography-mass spectrometry (GC-MS). We sought to develop and validate a quantitative ultra-performance liquid chromatography quadrupole time-of-flight (UPLC-QTOF) method with a \"dilute-and-shoot\" approach.</p><p><strong>Methods: </strong>20 µL of calibrator, quality control material, or urine specimen, normalized by creatinine concentration, was mixed with mobile phase A (0.05% formic acid in water) and internal standards to a final volume of 440 µL. The supernatant was injected onto a Waters ACUITY Premier HSS T3 UPLC column, with data acquired in MSE mode on a Waters Xevo G3 QTOF mass spectrometer and quantification achieved using both linear and quadratic regressions.</p><p><strong>Results: </strong>The method quantifies 27 analytes and separates diagnostically important isomers in 20 minutes. Repeatability and reproducibility were 12% or less coefficient of variation, with no carryover observed. Spike-recovery studies demonstrated recoveries between 85% and 115%, and concordant results were obtained from 51 urine specimens vs the conventional GC-MS method. No matrix effect was identified except for 3-hydroxyglutaric acid. Compared with other UPLC-QTOF methods, improved chromatographic performance was achieved with the Premier HSS T3 column, while MSE high-resolution MS data provided fragmentation information to support higher-confidence compound identification. Compared with conventional GC-MS methods, this method requires substantially lower specimen volume and simplified sample preparation.</p><p><strong>Conclusions: </strong>This UPLC-QTOF dilute-and-shoot urine organic acid method demonstrated acceptable analytical and clinical performance. Continued optimization will be pursued to expand the panel and support the diagnosis of a broader range of inborn errors of metabolism.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148175235","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":"Intestinal spirochetosis in the modern era: a decade-long clinicopathologic study.","authors":"Poojaben Dhorajiya, Mansi Singal, Rifat Mannan","doi":"10.1093/ajcp/aqag069","DOIUrl":"10.1093/ajcp/aqag069","url":null,"abstract":"<p><strong>Objectives: </strong>Intestinal spirochetosis (IS) is infrequently identified in about 1% of human colonic biopsy specimens. On routine sections, it is diagnosed by identifying a thick band of basophilia on the apical surface of colonic mucosa. Intestinal spirochetosis is caused by Brachyspira pilosicoli and Brachyspira aalborgi, but whether it represents a commensalism or a pathogenic process remains debated.</p><p><strong>Methods: </strong>We studied 175 cases of IS diagnosed at our institution over a 10-year period. The clinicopathologic features were reviewed using hematoxylin and eosin (H&E)-stained slides, along with the results from histochemical and immunohistochemical analyses.</p><p><strong>Results: </strong>All cases were diagnosed by colonoscopic biopsy, except for 1 case. Indications for colonoscopy were unexplained diarrhea (48.6%), colorectal cancer screening (36%), rectal bleeding (6.3%), abdominal pain (4%), follow-up for ulcerative colitis (4%), Crohn disease (0.6%), and constipation (0.6%). Associated significant clinical conditions included HIV-positive status (14.3%), diabetes mellitus (1.7%), post-liver transplant (0.6%), retroperitoneal liposarcoma (0.6%), prostate cancer (0.6%), and Kaposi sarcoma (0.6%). Pathologic changes in background colonic mucosa included unremarkable (89%), active inflammation (6%), hyperplastic polyp (1.7%), tubular adenoma (1.7%), and Trichuris trichiura infestation (0.6%). On H&E, all cases had the characteristic basophilic hue on the epithelial surface of colonic mucosa.</p><p><strong>Conclusions: </strong>Intestinal spirochetosis in our study had a striking male predominance and affected both immunocompetent and immunosuppressed individuals. Nearly two-thirds of the patients were symptomatic, indicating that IS is likely a pathogenic infection of low virulence. Histologically, IS can involve normal, inflamed, and dysplastic epithelium.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148248792","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":"Diagnostic practices and variability in autoimmune gastritis: a national survey of gastrointestinal pathologists.","authors":"Muhammad Hassaan Khalid, Asad Ur Rehman, Bennett Phuoc Christie-Nguyen, Alexander Banerjee, Amirali Tahanan, Minjae Lee, Erin Rubin, Suhair Al Salihi, Antonio Galvao Neto, Rossana Kazemimood","doi":"10.1093/ajcp/aqag068","DOIUrl":"10.1093/ajcp/aqag068","url":null,"abstract":"<p><strong>Objectives: </strong>Autoimmune gastritis (AIG) is characterized by well-described histologic features, yet diagnostic thresholds and reporting practices vary in routine pathology practice. This study aimed to characterize variability in evaluation, ancillary testing, and reporting of AIG across diverse pathology practice settings and training backgrounds.</p><p><strong>Methods: </strong>We conducted a national, anonymized, cross-sectional online survey for practicing pathologists who routinely sign out gastric biopsies. The survey assessed diagnostic criteria for AIG, use of ancillary studies, reporting practices, and approaches to overlapping Helicobacter pylori gastritis. Associations between respondent characteristics and diagnostic behaviors were evaluated using χ2 tests and multivariable logistic regression.</p><p><strong>Results: </strong>A total of 163 pathologists completed the survey. Diagnostic thresholds for AIG varied widely, ranging from strict criteria requiring oxyntic gland atrophy, intestinal metaplasia, and enterochromaffin-like-cell hyperplasia to broader approaches recognizing atrophy alone. Only 22% of respondents reported AIG in the main report, while 43% reported in the comments and only one-third routinely subtyped intestinal metaplasia. In all, 52% of respondents routinely ordered gastrin immunohistochemistry in random gastric biopsies. Academic settings were associated with greater reporting detail, while gastrointestinal pathology fellowship training was associated with the use of qualifying terminology such as \"early\" or \"suspicious\" AIG (P = .01). Approaches to cases with concurrent H pylori gastritis and oxyntic gland atrophy also showed substantial variability.</p><p><strong>Conclusions: </strong>Diagnostic evaluation and reporting of AIG remain highly variable and are associated with subspecialty training, practice environment, and years of experience. These findings highlight the need for consensus-based guidance to improve consistency, communication, and clinical integration of AIG diagnoses.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148248761","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":"Factors predicting histopathologic response to neoadjuvant chemotherapy in patients with peritoneal metastases from colorectal cancer.","authors":"Coca-Mihaela Vieru, Wenceslao Vásquez Jiménez, Olga Mateo Sierra, Emma Sola Vendrell, María Jesús Fernández Aceñero","doi":"10.1093/ajcp/aqag055","DOIUrl":"10.1093/ajcp/aqag055","url":null,"abstract":"<p><strong>Objectives: </strong>Select patients with colorectal cancer with peritoneal metastases may undergo a curative-intent cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy after neoadjuvant systemic chemotherapy. Factors predicting pathologic complete response (CR) remain poorly defined, as do eligibility criteria for this aggressive therapy. We aimed to evaluate the pathologic CR rate following neoadjuvant chemotherapy and develop a predictive model for treatment response to optimize patient selection and benefit-risk assessment within the personalized medicine framework.</p><p><strong>Methods: </strong>This single-center retrospective cohort study included 178 patients treated with neoadjuvant chemotherapy followed by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy between 2003 and 2019. After analyzing demographic, clinicopathologic, and perioperative variables, we performed a multivariate analysis.</p><p><strong>Results: </strong>The median peritoneal carcinomatosis index was 9, complete cytoreduction was achieved in 88.7% of patients, and pathologic CR was observed in 19 (10.7%) patients. Tumor histological subtype, lymph node involvement, vascular invasion, and peritoneal carcinomatosis index were statistically significantly associated with histologic response (P = .016, P = .032, P = .035, and P < .001, respectively). In multivariate analysis, tumor histologic subtype was the only independent predictor of response (odds ratio, 0.271 [95% CI, 0.075-0.988], P = .048) and was used to generate a logistic regression model with moderate discriminative performance (area under the curve = 0.638 [95% CI, 0.519-0.757], P = .049). Mucinous histology is a negative prognostic factor, with approximately 3-fold lower probability of achieving pathologic CR compared with enteroid type.</p><p><strong>Conclusions: </strong>Although larger prospective studies are needed to validate these findings, our model supports the potential integration of histologic subtype into prognostic scoring systems to better define criteria for selecting patients more bound to respond to this aggressive therapy.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148248764","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":"Autoimmune central nervous system testing at an academic medical center: the challenges of improving test utilization.","authors":"Paul E Bernard, Emily J Gilmore, Erin E Longbrake, Marie L Landry","doi":"10.1093/ajcp/aqag038","DOIUrl":"10.1093/ajcp/aqag038","url":null,"abstract":"<p><strong>Objectives: </strong>We sought to improve test utilization for 8 autoimmune antibody panels.</p><p><strong>Methods: </strong>Three interventions (test ordering guidance, clinical pathway guidance, and duplicate test blocking) were implemented at 6-month intervals. Over 3 years, we recorded trends in test volumes, duplicate tests, and positive results. We conducted chart reviews for two 3-month periods 1 year apart to assess the impact on patient Antibody Prevalence in Epilepsy and Encephalopathy (APE2) scores.</p><p><strong>Results: </strong>Comparing the first 6 months with the last 6 months of the 3-year study, we observed a 36.5% decrease in overall test volume and a 95.5% reduction in duplicate tests. The final true-positive rate based on clinical diagnosis was low, however, at only 1.6% (40/2550) of tests performed and 1.3% (24/1883) of patients tested. Performance did not improve over the study period. Chart reviews (n = 194) showed only 8 of 106 (7.5%) patients had an APE2 score of at least 4 in January through March 2023, and 12 of 88 (13.6%) met this threshold in January through March 2024. Two of 20 total patients with an APE2 score of at least 4 had a new diagnosis of autoimmune central nervous system disease compared with 0 of 174 patients with a score below 4 (P < .001), affirming the predictive value of the scorecard.</p><p><strong>Conclusions: </strong>Although reductions in test volume and duplicate testing were observed, clinicians continued to order a substantial number of tests for patients whose clinical picture was not suggestive of autoimmune epilepsy or encephalopathy. Although there was some improvement in appropriate ordering when assessed by retrospective APE2 scores, this value did not reach statistical significance.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148161429","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":"Reevaluation of Lyme serologic quantitative test indexes: confirmation that high first-tier test index values predict a positive second-tier result in a modified 2-tier Lyme testing algorithm.","authors":"Elizabeth- Lee-Lewandrowski, Kent Lewandrowski","doi":"10.1093/ajcp/aqag051","DOIUrl":"10.1093/ajcp/aqag051","url":null,"abstract":"<p><strong>Objectives: </strong>In a previous study, we reported that using a first-tier quantitative Lyme serologic index may obviate the need for second-tier confirmatory testing in samples above a defined cutoff value. Here we have expanded on the sample size to confirm and better refine the potential utility of the serologic index to aid in timely clinical decision-making.</p><p><strong>Methods: </strong>We reviewed 1 year of Lyme serologic test results sent to our laboratory for testing using a modified 2-tier testing algorithm (MTTT) to determine the probability of second-tier confirmation based on the initial Lyme index value.</p><p><strong>Results: </strong>Using the original Lyme index cutoff at which 100% of samples confirmed on second-tier testing (2.68), in the expanded dataset, 98.7% of samples confirmed at this cutoff. Using all of the expanded sample set data, we defined 6 Lyme index brackets from highly positive to equivocal to estimate the probability of the first-tier test confirming on second-tier testing. We also constructed a formula relating the index to the probability of confirmation across the continuum of index values to predict second-tier confirmation in an MTTT algorithm.</p><p><strong>Conclusions: </strong>The use of a Lyme test index value may eliminate the need for confirmatory testing on many positive first-tier samples in patients suspected of having Lyme disease. First-tier Lyme test results may be improved by reporting the index value along with the probability of confirmation. This may facilitate more timely diagnosis and clinical decision-making and potentially improve the time to antimicrobial therapy.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148196822","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":"CD48 expression in T-lymphoblastic leukemia/lymphoma and mature T-cell neoplasms: role in detecting measurable residual disease and potential confounders, a single-institution retrospective review.","authors":"Alireza Torabi, Jonathan R Fromm, Russell Dorer, Yanna Ding, Emily Glynn, Kerstin L Edlefsen, Afshin Shameli, David Wu, Sindhu Cherian","doi":"10.1093/ajcp/aqag060","DOIUrl":"10.1093/ajcp/aqag060","url":null,"abstract":"<p><strong>Objectives: </strong>Assessing the stage of maturation is critical for the classification of T-cell neoplasms and is helpful in minimal/measurable residual disease (MRD) testing for T-lymphoblastic leukemia (T-ALL). This study analyzes the utility of CD48 in characterizing T-cell neoplasms at diagnosis and posttherapy.</p><p><strong>Methods: </strong>This retrospective review characterizes the expression of CD48 in T-ALL and mature T-cell neoplasms at diagnosis and posttreatment. CD48 intensity was assessed qualitatively by flow cytometry relative to the background T cells. Potential confounders were also evaluated.</p><p><strong>Results: </strong>T cells show increases in CD48 expression with progressive maturation, with high-level expression on mature T cells. CD48 expression by flow cytometry was decreased to absent (compared with expression on mature T cells) in 100% of T-ALL cases at diagnosis and in 92% of cases positive for MRD posttherapy. By contrast, among mature T-cell neoplasms, CD48 expression at diagnosis overlapped with expression on background mature T cells in most cases (91%). Reduced CD48 expression on background, nonneoplastic T cells was seen in the setting of alemtuzumab therapy and in samples with glycosylphosphatidylinositol (GPI)-deficient populations.</p><p><strong>Conclusions: </strong>CD48 expression is diminished compared with normal background T cells in most cases of T-ALL at diagnosis and posttherapy, whereas it was typically retained in mature T-cell/natural killer-cell neoplasms. While CD48 levels may fluctuate after chemotherapy in T-ALL, reduced CD48 can be used as a marker of immaturity in most MRD cases. Potential confounders in the assessment of CD48 include alemtuzumab therapy and the presence of GPI-deficient populations.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148215866","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":"Lower limit of detection of commercial respiratory virus reverse transcriptase-polymerase chain reaction panels for bovine influenza A(H5N1).","authors":"Grant P Higerd-Rusli, Seth A Hoffman, Abraar Karan, ChunHong Huang, Malaya K Sahoo, Matthew M Hernandez, Benjamin A Pinsky","doi":"10.1093/ajcp/aqag067","DOIUrl":"10.1093/ajcp/aqag067","url":null,"abstract":"<p><strong>Objectives: </strong>The adaptation of clade 2.3.4.4b influenza A(H5N1) to dozens of mammalian species, including dairy cattle, raises concerns about potential spillover into humans. If the virus develops human-to-human transmissibility, sensitive diagnostics will be critical to containment efforts. We sought to determine the lower limit of detection of commercial influenza A tests for the circulating bovine-adapted strain of H5N1.</p><p><strong>Methods: </strong>We determined the 95% lower limit of detection (LLOD) of 4 commercial respiratory virus panels for detecting inactivated bovine H5N1 (A/bovine/Ohio/B24OSU-439/2024). Two of the tested panels provide seasonal influenza A subtyping, the BioFire Respiratory Panel 2.1 (BioFire Diagnostics/BioMérieux) and the cobas eplex respiratory pathogen panel 2 (Roche Diagnostics), while 2 panels provide pan-influenza A detection, the Xpert Xpress CoV-2/Flu/RSV plus (Cepheid), and the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (Hologic, Inc). Serial dilutions of H5 RNA (400-25 copies/mL) were prepared in respiratory virus-negative nasopharyngeal swab matrix, and 20 replicates were tested at each concentration. The 95% LLOD for each test was calculated using probit regression.</p><p><strong>Results: </strong>All 4 tests detected H5 with 95% LLODs below 1000 H5 RNA copies/mL. Xpert demonstrated the highest analytical sensitivity (50 copies/mL; 95% CI, 39-160), followed by BioFire (297 copies/mL; 95% CI, 196-3955), Panther Fusion (531 copies/mL; 95% CI, 421-792), and eplex (883 copies/mL; 95% CI, 588-2741).</p><p><strong>Conclusions: </strong>Existing commercial respiratory virus panels can effectively detect bovine H5N1. These platforms could support screening in the event of an H5N1 outbreak, followed by confirmation with specific H5 subtyping, as needed.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":"165 6","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148269974","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}