Objectives: We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.
Methods: Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.
Results: The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.
Conclusions: Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.
研究目的我们比较了 Alinity i 分析仪(雅培实验室)上最新获得美国食品和药物管理局批准的他克莫司测定法(CMIA)和 2 家参考实验室基于液相色谱/串联质谱(LC-MS/MS)的方法得出的他克莫司浓度。我们还研究了 CMIA 他克莫司检测法与 Elecsys 他克莫司检测法之间的相关性:方法:使用 Alinity i 分析仪通过化学发光微粒子免疫分析法(CMIA)测定 EDTA 全血中他克莫司的浓度,然后将 2 份等分样品送至 2 个参考实验室,这 2 个实验室均使用阿霉素作为 LC-MS/MS 方法的内标:结果:CMIA 他克莫司测定法的总精密度非常高。将参考实验室 A 用 LC-MS/MS 方法获得的他克莫司浓度绘制在 x 轴上,相应的 CMIA 值绘制在 y 轴上,可观察到以下回归方程:y = 0.9721x + 1.005(r = 0.95),表明 CMIA 无明显偏差。然而,当使用参考实验室 B 的他克莫司值进行比较时,回归方程为 y = 0.7664x + 1.775(r = 0.93),表明 CMIA 存在明显的负偏差。当我们比较参考实验室 A 和 B 所获得的他克莫司浓度时,我们发现参考实验室 B 所获得的他克莫司浓度存在正偏差,但 CMIA 和 Elecsys 免疫测定法所获得的他克莫司浓度相当:由于使用 CMIA 和参考实验室 A(我们的长期药物分析参考实验室)的 LC-MS/MS 测得的他克莫司浓度具有良好的相关性,我们认为 Alinity i 上的 CMIA 可用于他克莫司的治疗药物监测。
{"title":"Good correlation between tacrolimus concentrations using improved CMIA on the Alinity i analyzer and LC-MS/MS method from a reference laboratory but unexpected negative bias with another LC-MS/MS method from a different reference laboratory.","authors":"Kelsey Woodard, Tracey Kisler, Amitava Dasgupta","doi":"10.1093/ajcp/aqae005","DOIUrl":"10.1093/ajcp/aqae005","url":null,"abstract":"<p><strong>Objectives: </strong>We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.</p><p><strong>Methods: </strong>Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.</p><p><strong>Results: </strong>The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.</p><p><strong>Conclusions: </strong>Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721202","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}
Miguel S Gonzalez-Mancera, Andrew Siref, Kambiz Kosari, Nicholas Nissen, Srinivas Gaddam, Andrew Hendifar, Arsen Osipov, Kevin Waters, Danielle Hutchings, Maha Guindi, Brent K Larson
Objectives: Adenocarcinomas of the biliary tract frequently present diagnostic challenges because of their histologic overlap with benign and preinvasive lesions. The molecular profiles of biliary adenocarcinomas vary by anatomical location. Variations in IDH1/2, common in intrahepatic cholangiocarcinoma, can lead to defective production of 5-hydroxymethylcytosine (5-hmC). Limited ancillary studies are available for biliary adenocarcinomas, and loss of 5-hmC staining could serve as a helpful ancillary diagnostic tool for biliary tract malignancies.
Methods: We evaluated 93 cases-20 benign biliary lesions, 15 preinvasive biliary neoplasms, 46 invasive biliary carcinomas, and 12 pancreatic adenocarcinomas-for 5-hmC staining. Preoperative biopsies from 16 cases of biliary carcinoma were also stained. Sixteen nonneoplastic/reactive bile duct biopsies served as controls.
Results: Loss of 5-hmC was seen in 41 of 46 (89.1%) biliary malignancies vs 0 of 20 benign tumors (P < .001), for a sensitivity and specificity of 89.1% and 100%, respectively. Intrahepatic cholangiocarcinoma showed loss of 5-hmC in 11 of 13 (84.6%) cases, similar to the 30 of 33 (90.9%) cases in other biliary adenocarcinomas (P = .61). Similarly, 5-hmC loss was more frequent in distal bile duct adenocarcinomas than in pancreatic ductal adenocarcinomas, at 15 of 17 (88.2%) vs 4 of 12 (33.3%), respectively (P = .0045). There was no difference in the frequency of 5-hmC loss in patients that received neoadjuvant therapy vs those who did not (90.9% vs 88.6%, P > .99). 5-hmC immunohistochemistry in preoperative biopsies was concordant with the resection specimen in 81.3% (13/16) of cases.
Conclusions: Loss of 5-hmC is not unique to intrahepatic cholangiocarcinoma among biliary carcinomas, but is a useful diagnostic marker differentiating malignancies of the biliary tree from benign mimics.
{"title":"5-Hydroxymethylcytosine (5-hmC) loss is a marker of malignancy in biliary neoplasms.","authors":"Miguel S Gonzalez-Mancera, Andrew Siref, Kambiz Kosari, Nicholas Nissen, Srinivas Gaddam, Andrew Hendifar, Arsen Osipov, Kevin Waters, Danielle Hutchings, Maha Guindi, Brent K Larson","doi":"10.1093/ajcp/aqae001","DOIUrl":"10.1093/ajcp/aqae001","url":null,"abstract":"<p><strong>Objectives: </strong>Adenocarcinomas of the biliary tract frequently present diagnostic challenges because of their histologic overlap with benign and preinvasive lesions. The molecular profiles of biliary adenocarcinomas vary by anatomical location. Variations in IDH1/2, common in intrahepatic cholangiocarcinoma, can lead to defective production of 5-hydroxymethylcytosine (5-hmC). Limited ancillary studies are available for biliary adenocarcinomas, and loss of 5-hmC staining could serve as a helpful ancillary diagnostic tool for biliary tract malignancies.</p><p><strong>Methods: </strong>We evaluated 93 cases-20 benign biliary lesions, 15 preinvasive biliary neoplasms, 46 invasive biliary carcinomas, and 12 pancreatic adenocarcinomas-for 5-hmC staining. Preoperative biopsies from 16 cases of biliary carcinoma were also stained. Sixteen nonneoplastic/reactive bile duct biopsies served as controls.</p><p><strong>Results: </strong>Loss of 5-hmC was seen in 41 of 46 (89.1%) biliary malignancies vs 0 of 20 benign tumors (P < .001), for a sensitivity and specificity of 89.1% and 100%, respectively. Intrahepatic cholangiocarcinoma showed loss of 5-hmC in 11 of 13 (84.6%) cases, similar to the 30 of 33 (90.9%) cases in other biliary adenocarcinomas (P = .61). Similarly, 5-hmC loss was more frequent in distal bile duct adenocarcinomas than in pancreatic ductal adenocarcinomas, at 15 of 17 (88.2%) vs 4 of 12 (33.3%), respectively (P = .0045). There was no difference in the frequency of 5-hmC loss in patients that received neoadjuvant therapy vs those who did not (90.9% vs 88.6%, P > .99). 5-hmC immunohistochemistry in preoperative biopsies was concordant with the resection specimen in 81.3% (13/16) of cases.</p><p><strong>Conclusions: </strong>Loss of 5-hmC is not unique to intrahepatic cholangiocarcinoma among biliary carcinomas, but is a useful diagnostic marker differentiating malignancies of the biliary tree from benign mimics.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721176","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}
Constance Béchu, Anne Rullier, Pierre-Emmanuel Lesoin, Lucie Gaillot-Durand, Alexis Trecourt, Pierre Gosset, Cyprien Tilmant
Objectives: The health sector contributes to climate disruption through greenhouse gas (GHG) emissions. It accounts for 8% to 10% of France's GHG emissions. Although the medical community has been alerted to the problem, more data are needed. This study aimed to determine the carbon footprint of a surgical pathology laboratory.
Methods: The study was conducted in the surgical pathology laboratory at Saint Vincent hospital (Lille) in 2021. It represented 17,242 patient cases corresponding to 54,124 paraffin blocks. The 17 staff members performed cytology, immunohistochemistry, and in situ hybridization. The study included all inputs, capital equipment, freight, travel, energy consumption, and waste. Carbon emission factors were based on the French Agence De l'Environnement et de la Maîtrise de l'Energie database.
Results: In 2021, the pathology laboratory's carbon footprint was 117 tons of CO2 equivalent (t CO2e), corresponding to 0.5% of Saint Vincent hospital's total emissions. The most significant emissions categories were inputs (60 t CO2e; 51%), freight associated with inputs (24 t CO2e; 20%), and travel (14 t CO2e; 12%). Waste and energy generated 10 t CO2e (9%) and 9 t CO2e (8%), respectively.
Conclusions: The pathology laboratory's carbon footprint was equivalent to the yearly carbon impact of 11 French inhabitants. This footprint is dominated by inputs and associated freight. This suggests an urgent need to develop ecodesign and self-sufficiency in our routine practices.
{"title":"The carbon footprint of a surgical pathology laboratory in France.","authors":"Constance Béchu, Anne Rullier, Pierre-Emmanuel Lesoin, Lucie Gaillot-Durand, Alexis Trecourt, Pierre Gosset, Cyprien Tilmant","doi":"10.1093/ajcp/aqae022","DOIUrl":"10.1093/ajcp/aqae022","url":null,"abstract":"<p><strong>Objectives: </strong>The health sector contributes to climate disruption through greenhouse gas (GHG) emissions. It accounts for 8% to 10% of France's GHG emissions. Although the medical community has been alerted to the problem, more data are needed. This study aimed to determine the carbon footprint of a surgical pathology laboratory.</p><p><strong>Methods: </strong>The study was conducted in the surgical pathology laboratory at Saint Vincent hospital (Lille) in 2021. It represented 17,242 patient cases corresponding to 54,124 paraffin blocks. The 17 staff members performed cytology, immunohistochemistry, and in situ hybridization. The study included all inputs, capital equipment, freight, travel, energy consumption, and waste. Carbon emission factors were based on the French Agence De l'Environnement et de la Maîtrise de l'Energie database.</p><p><strong>Results: </strong>In 2021, the pathology laboratory's carbon footprint was 117 tons of CO2 equivalent (t CO2e), corresponding to 0.5% of Saint Vincent hospital's total emissions. The most significant emissions categories were inputs (60 t CO2e; 51%), freight associated with inputs (24 t CO2e; 20%), and travel (14 t CO2e; 12%). Waste and energy generated 10 t CO2e (9%) and 9 t CO2e (8%), respectively.</p><p><strong>Conclusions: </strong>The pathology laboratory's carbon footprint was equivalent to the yearly carbon impact of 11 French inhabitants. This footprint is dominated by inputs and associated freight. This suggests an urgent need to develop ecodesign and self-sufficiency in our routine practices.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140100843","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}
V Rakesh Sethapati, Tho D Pham, Thinh Quach, Anhthu Nguyen, Jimmy Le, Wei Cai, Mrigender Singh Virk
Objectives: Cryoprecipitated antihemophilic factor (cryo) has been used for fibrinogen replacement in actively bleeding patients, dysfibrinogenemia, and hypofibrinogenemia. Cryo has a shelf life of 4 to 6 hours after thawing and a long turnaround time in issuing the product, posing a major limitation of its use. Recently, the US Food and Drug Administration approved Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex [IFC]) for the treatment of bleeding associated with fibrinogen deficiency, which can be stored at room temperature and has a shelf life of 5 days after thawing.
Methods: We identified locations and specific end users with high cryoprecipitate utilization and waste. We partnered with our blood supplier to use IFC in these locations. We analyzed waste and turnaround time before and after implementation.
Results: Operative locations had a waste rate that exceeded nonoperative locations (16.7% vs 3%) and were targeted for IFC implementation. IFC was added to our inventory to replace all cryo orders from adult operating rooms, and waste decreased to 2.2% in these locations. Overall waste of cryoprecipitated products across all locations was reduced from 8.8% to 2.4%. The turnaround time for cryoprecipitated products was reduced by 58% from 30.4 minutes to 14.6 minutes.
Conclusions: There has been a substantial decrease in waste with improved turnaround time after IFC implementation. This has improved blood bank logistics, improved efficiency of patient care, and reduced costly waste.
{"title":"Implementation and early outcomes with Pathogen Reduced Cryoprecipitated Fibrinogen Complex.","authors":"V Rakesh Sethapati, Tho D Pham, Thinh Quach, Anhthu Nguyen, Jimmy Le, Wei Cai, Mrigender Singh Virk","doi":"10.1093/ajcp/aqae073","DOIUrl":"https://doi.org/10.1093/ajcp/aqae073","url":null,"abstract":"<p><strong>Objectives: </strong>Cryoprecipitated antihemophilic factor (cryo) has been used for fibrinogen replacement in actively bleeding patients, dysfibrinogenemia, and hypofibrinogenemia. Cryo has a shelf life of 4 to 6 hours after thawing and a long turnaround time in issuing the product, posing a major limitation of its use. Recently, the US Food and Drug Administration approved Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex [IFC]) for the treatment of bleeding associated with fibrinogen deficiency, which can be stored at room temperature and has a shelf life of 5 days after thawing.</p><p><strong>Methods: </strong>We identified locations and specific end users with high cryoprecipitate utilization and waste. We partnered with our blood supplier to use IFC in these locations. We analyzed waste and turnaround time before and after implementation.</p><p><strong>Results: </strong>Operative locations had a waste rate that exceeded nonoperative locations (16.7% vs 3%) and were targeted for IFC implementation. IFC was added to our inventory to replace all cryo orders from adult operating rooms, and waste decreased to 2.2% in these locations. Overall waste of cryoprecipitated products across all locations was reduced from 8.8% to 2.4%. The turnaround time for cryoprecipitated products was reduced by 58% from 30.4 minutes to 14.6 minutes.</p><p><strong>Conclusions: </strong>There has been a substantial decrease in waste with improved turnaround time after IFC implementation. This has improved blood bank logistics, improved efficiency of patient care, and reduced costly waste.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533295","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}
Ashley Hagiya, Imran N Siddiqi, Endi Wang, Chuanyi M Lu
Objectives: To discuss VEXAS (vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic) syndrome, including the clinical and pathologic features, diagnostic challenges, and treatment options.
Methods: A case-based approach and pertinent literature review were used to highlight the features of VEXAS syndrome, describe how to make the diagnosis, and discuss available therapies.
Results: VEXAS syndrome is an adult-onset, progressive systemic inflammatory disorder with overlapping rheumatologic and hematologic manifestations, including an increased risk of myelodysplastic neoplasms and plasma cell neoplasms. The disorder is associated with a somatic mutation of the X-linked UBA1 gene involved in ubiquitylation, typically involving p.Met41; however, rare variations have been identified outside this region. Patients often present with complex histories and see physicians from multiple specialties before receiving the diagnosis, which is often delayed. Symptoms are related to inflammation as well as cytopenias, particularly macrocytic anemia. Characteristic cytoplasmic vacuoles are present in myeloid (granulocytic, monocytic) and erythroid precursors in the vast majority of cases.
Conclusions: Either clinicians or pathologists may suspect a diagnosis of VEXAS syndrome depending on the clinical presentation and bone marrow findings. More studies are needed to determine the best therapeutic options, which are currently limited.
摘要讨论VEXAS(空泡、E1酶、X连锁、自身炎症、体质)综合征,包括临床和病理特征、诊断难题和治疗方案:方法:采用基于病例的方法和相关文献综述来突出 VEXAS 综合征的特征,描述如何做出诊断,并讨论可用的疗法:VEXAS综合征是一种成人发病的进行性全身炎症性疾病,具有重叠的风湿病学和血液学表现,包括骨髓增生异常性肿瘤和浆细胞肿瘤的风险增加。这种疾病与参与泛素化的 X 连锁 UBA1 基因的体细胞突变有关,通常涉及 p.Met41;但也发现了该区域以外的罕见变异。患者通常病史复杂,在确诊前要看多个专科的医生,而确诊往往被延迟。症状与炎症和细胞减少有关,尤其是巨幼红细胞性贫血。绝大多数病例的骨髓(粒细胞、单核细胞)和红细胞前体都存在特征性胞浆空泡:结论:临床医生或病理学家可根据临床表现和骨髓检查结果怀疑 VEXAS 综合征的诊断。需要进行更多的研究,以确定目前有限的最佳治疗方案。
{"title":"How I diagnose and manage VEXAS syndrome.","authors":"Ashley Hagiya, Imran N Siddiqi, Endi Wang, Chuanyi M Lu","doi":"10.1093/ajcp/aqae017","DOIUrl":"10.1093/ajcp/aqae017","url":null,"abstract":"<p><strong>Objectives: </strong>To discuss VEXAS (vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic) syndrome, including the clinical and pathologic features, diagnostic challenges, and treatment options.</p><p><strong>Methods: </strong>A case-based approach and pertinent literature review were used to highlight the features of VEXAS syndrome, describe how to make the diagnosis, and discuss available therapies.</p><p><strong>Results: </strong>VEXAS syndrome is an adult-onset, progressive systemic inflammatory disorder with overlapping rheumatologic and hematologic manifestations, including an increased risk of myelodysplastic neoplasms and plasma cell neoplasms. The disorder is associated with a somatic mutation of the X-linked UBA1 gene involved in ubiquitylation, typically involving p.Met41; however, rare variations have been identified outside this region. Patients often present with complex histories and see physicians from multiple specialties before receiving the diagnosis, which is often delayed. Symptoms are related to inflammation as well as cytopenias, particularly macrocytic anemia. Characteristic cytoplasmic vacuoles are present in myeloid (granulocytic, monocytic) and erythroid precursors in the vast majority of cases.</p><p><strong>Conclusions: </strong>Either clinicians or pathologists may suspect a diagnosis of VEXAS syndrome depending on the clinical presentation and bone marrow findings. More studies are needed to determine the best therapeutic options, which are currently limited.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140179074","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}
Objectives: Previous studies have been inconsistent concerning the association between the prognostic value of CD30 expression and extranodal natural killer/T-cell lymphoma (ENKTL).
Methods: CD30 expression in 82 patients with newly diagnosed ENKTL (mean age, 50 years; 73.2% male) was assessed by immunohistochemistry on paraffin-embedded sections. The level of CD30 expression was categorized into negative (0%, no staining) and positive groups.
Results: Sixty-seven cases exhibited positive CD30 expression, and the main between-group difference was the Chinese Southwest Oncology Group and Asia Lymphoma Study Group (CA) ENKTL stage and Eastern Cooperative Oncology Group (ECOG) performance status. The cutoff point for CD30 expression was 40% by restricted cubic splines analysis. The overall survival of patients with high expression (>40%) was statistically superior to negative (0%) and low-expression groups. A positive correlation was observed between CD30 and Epstein-Barr virus-encoded small RNA status (r = 0.305). Multivariable analysis suggested that positive CD30 expression (hazard ratio, 0.420 [95% CI, 0.193-0.914]; P = .029) and CA advanced stage (hazard ratio, 2.844 [95% CI, 1.371-5.896]; P = .005) were independent prognostic factors for ENKTL.
Conclusions: Positive CD30 expression was a favorable prognostic factor for ENKTL, and CD30 expression could restratify the survival of patients in clinical subgroups.
{"title":"Clinicopathologic features and survival outcomes of CD30 expression in extranodal natural killer/T-cell lymphoma.","authors":"Ziyuan Shen, Yubo Wang, Ruiyang Xie, Qing Zhang, Xing Xing, Shuo Zhang, Hui Liu, Wei Sang","doi":"10.1093/ajcp/aqae012","DOIUrl":"10.1093/ajcp/aqae012","url":null,"abstract":"<p><strong>Objectives: </strong>Previous studies have been inconsistent concerning the association between the prognostic value of CD30 expression and extranodal natural killer/T-cell lymphoma (ENKTL).</p><p><strong>Methods: </strong>CD30 expression in 82 patients with newly diagnosed ENKTL (mean age, 50 years; 73.2% male) was assessed by immunohistochemistry on paraffin-embedded sections. The level of CD30 expression was categorized into negative (0%, no staining) and positive groups.</p><p><strong>Results: </strong>Sixty-seven cases exhibited positive CD30 expression, and the main between-group difference was the Chinese Southwest Oncology Group and Asia Lymphoma Study Group (CA) ENKTL stage and Eastern Cooperative Oncology Group (ECOG) performance status. The cutoff point for CD30 expression was 40% by restricted cubic splines analysis. The overall survival of patients with high expression (>40%) was statistically superior to negative (0%) and low-expression groups. A positive correlation was observed between CD30 and Epstein-Barr virus-encoded small RNA status (r = 0.305). Multivariable analysis suggested that positive CD30 expression (hazard ratio, 0.420 [95% CI, 0.193-0.914]; P = .029) and CA advanced stage (hazard ratio, 2.844 [95% CI, 1.371-5.896]; P = .005) were independent prognostic factors for ENKTL.</p><p><strong>Conclusions: </strong>Positive CD30 expression was a favorable prognostic factor for ENKTL, and CD30 expression could restratify the survival of patients in clinical subgroups.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929503","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}
Roa Harb, Robert Tuggey, Jack H Ladenson, Timothy Amukele
Objectives: This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017.
Methods: Laboratories were enrolled in the condensed chemical pathology EQA program provided by the Royal College of Pathologists of Australasia Quality Assurance Program. Participants were given an initial 2- to 4-day in-person training, followed by 1 year of active feedback on performance via emails or phone calls by a PO volunteer.
Results: There were 2 performance metrics: percentage of reported results as a measure of compliance and percentage of acceptable reported results as a measure of accuracy. Laboratories demonstrated high compliance with result reporting, with medians of 69.9%, 71.7%, and 81.3% before, during, and after feedback, respectively. Concomitant medians for the percentage of acceptable reported results were 41.2%, 57.3%, and 53.5%, respectively. Six laboratories had low performance in terms of accuracy at baseline (<60%). Active feedback improved the percentage of acceptable reported results for these lower-performing laboratories.
Conclusions: External quality assessment programs can be successfully adopted long term by laboratories in low-resource settings. Active feedback requires significant time and effort but could be especially beneficial for laboratories with poor baseline performance.
{"title":"Remote support of an external quality assessment program in 10 laboratories in Bhutan, Uganda, and Malawi: Pathologists Overseas experience between 2009 and 2017.","authors":"Roa Harb, Robert Tuggey, Jack H Ladenson, Timothy Amukele","doi":"10.1093/ajcp/aqae009","DOIUrl":"10.1093/ajcp/aqae009","url":null,"abstract":"<p><strong>Objectives: </strong>This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017.</p><p><strong>Methods: </strong>Laboratories were enrolled in the condensed chemical pathology EQA program provided by the Royal College of Pathologists of Australasia Quality Assurance Program. Participants were given an initial 2- to 4-day in-person training, followed by 1 year of active feedback on performance via emails or phone calls by a PO volunteer.</p><p><strong>Results: </strong>There were 2 performance metrics: percentage of reported results as a measure of compliance and percentage of acceptable reported results as a measure of accuracy. Laboratories demonstrated high compliance with result reporting, with medians of 69.9%, 71.7%, and 81.3% before, during, and after feedback, respectively. Concomitant medians for the percentage of acceptable reported results were 41.2%, 57.3%, and 53.5%, respectively. Six laboratories had low performance in terms of accuracy at baseline (<60%). Active feedback improved the percentage of acceptable reported results for these lower-performing laboratories.</p><p><strong>Conclusions: </strong>External quality assessment programs can be successfully adopted long term by laboratories in low-resource settings. Active feedback requires significant time and effort but could be especially beneficial for laboratories with poor baseline performance.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929505","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":"How Do I: The Academy of Clinical Laboratory Physicians and Scientists (ACLPS) publication series.","authors":"Amit A Gokhale","doi":"10.1093/ajcp/aqae006","DOIUrl":"10.1093/ajcp/aqae006","url":null,"abstract":"","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140179073","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}
Sarah E Bergholtz, Sophia R Kurnot, Esha Elahi, Melissa DeJonckheere, Sarah T Hawley, Scott R Owens, Simpa Salami, Todd M Morgan, Cathryn J Lapedis
Objectives: To characterize the role of pathology explanation clinics (PECs) in prostate cancer care and determine their impact on patients, urologic oncologists, and quality of care.
Methods: Semistructured interviews with 10 patients with newly diagnosed prostate cancer were conducted before and after a PEC pilot and at the 1- and 6-month follow-up visits. Information about participants' cancer knowledge and anxiety were collected quantitatively. Documented pathologist communications and proper review of outside biopsy slides were collected. Semistructured interviews were also completed with participating urologic oncologists following the pilot.
Results: Pathology explanation clinics improved participants' understanding of their diagnosis, cognitively and emotionally supporting them first in their urologic oncology visit and later in making an informed treatment decision. Mean knowledge scores were high, and a minority of participants had prostate cancer anxiety. Urologic oncologists noted improved understanding and reduced anxiety among participants, enabling nuanced conversations about prognosis and management during the visit. By ensuring review of outside biopsy slides and communication of clinically significant or unexpected diagnoses, PECs supported high-quality care and patient safety.
Conclusions: In this small pilot, PECs positively affected patients with prostate cancer, their clinicians, and the overall care system. Additional studies in larger populations and diverse settings will be useful.
{"title":"A longitudinal mixed-methods study of pathology explanation clinics in patients with newly diagnosed localized prostate cancer.","authors":"Sarah E Bergholtz, Sophia R Kurnot, Esha Elahi, Melissa DeJonckheere, Sarah T Hawley, Scott R Owens, Simpa Salami, Todd M Morgan, Cathryn J Lapedis","doi":"10.1093/ajcp/aqae008","DOIUrl":"10.1093/ajcp/aqae008","url":null,"abstract":"<p><strong>Objectives: </strong>To characterize the role of pathology explanation clinics (PECs) in prostate cancer care and determine their impact on patients, urologic oncologists, and quality of care.</p><p><strong>Methods: </strong>Semistructured interviews with 10 patients with newly diagnosed prostate cancer were conducted before and after a PEC pilot and at the 1- and 6-month follow-up visits. Information about participants' cancer knowledge and anxiety were collected quantitatively. Documented pathologist communications and proper review of outside biopsy slides were collected. Semistructured interviews were also completed with participating urologic oncologists following the pilot.</p><p><strong>Results: </strong>Pathology explanation clinics improved participants' understanding of their diagnosis, cognitively and emotionally supporting them first in their urologic oncology visit and later in making an informed treatment decision. Mean knowledge scores were high, and a minority of participants had prostate cancer anxiety. Urologic oncologists noted improved understanding and reduced anxiety among participants, enabling nuanced conversations about prognosis and management during the visit. By ensuring review of outside biopsy slides and communication of clinically significant or unexpected diagnoses, PECs supported high-quality care and patient safety.</p><p><strong>Conclusions: </strong>In this small pilot, PECs positively affected patients with prostate cancer, their clinicians, and the overall care system. Additional studies in larger populations and diverse settings will be useful.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929560","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}
Belinda L Sun, Alexis S Elliott, David Nolte, Xiaoguang Sun
Objectives: Immune checkpoint inhibitors, a revolutionary class of cancer immunotherapy drugs, have transformed cancer treatment by bolstering antitumor immunity for various advanced-stage solid cancers. The US Food and Drug Administration has approved 7 immune checkpoint inhibitors that target 3 major immune checkpoint proteins: cytotoxic T-lymphocyte-associated protein 4, programmed cell death 1 protein, and programmed cell death 1 ligand 1. In addition to their remarkable efficacy, however, these inhibitors have been observed causing immune-related adverse events, particularly immune checkpoint inhibitor-related colitis, which often results in severe or life-threatening clinical issues.
Methods: The diagnosis of immune checkpoint inhibitor-related colitis relies on incorporation of clinical evaluation as well as endoscopic and histopathologic examination, with exclusion of other potential etiologies.
Results: The common histopathologic manifestations of immune checkpoint inhibitor-related colitis are acute active colitis, chronic active colitis, microscopic colitis (collagenous or lymphocytic), and ischemic colitis, with patterns overlapping. Notably, enterocyte apoptosis is a unique feature of immune checkpoint inhibitor toxicity. The proposed mechanisms for the pathogenesis of immune checkpoint inhibitor-related colitis are primarily associated with autoimmune-type dysregulation and gut microbiome alteration. This review summarizes the clinical and pathologic characteristics of immune checkpoint inhibitor-related colitis and elucidates its underlying pathogenic mechanisms.
Conclusions: Future successful management of this form of colitis relies on our comprehension of the intricate interplay between tumoral and systemic immune responses to immune checkpoint inhibitors and innovative approaches to modify these responses, along with specific immune cell populations, to preclude immune-related adverse events while achieving antitumor therapeutic outcomes.
{"title":"Immune checkpoint inhibitor-related colitis in patients on immunotherapy for cancer.","authors":"Belinda L Sun, Alexis S Elliott, David Nolte, Xiaoguang Sun","doi":"10.1093/ajcp/aqae002","DOIUrl":"10.1093/ajcp/aqae002","url":null,"abstract":"<p><strong>Objectives: </strong>Immune checkpoint inhibitors, a revolutionary class of cancer immunotherapy drugs, have transformed cancer treatment by bolstering antitumor immunity for various advanced-stage solid cancers. The US Food and Drug Administration has approved 7 immune checkpoint inhibitors that target 3 major immune checkpoint proteins: cytotoxic T-lymphocyte-associated protein 4, programmed cell death 1 protein, and programmed cell death 1 ligand 1. In addition to their remarkable efficacy, however, these inhibitors have been observed causing immune-related adverse events, particularly immune checkpoint inhibitor-related colitis, which often results in severe or life-threatening clinical issues.</p><p><strong>Methods: </strong>The diagnosis of immune checkpoint inhibitor-related colitis relies on incorporation of clinical evaluation as well as endoscopic and histopathologic examination, with exclusion of other potential etiologies.</p><p><strong>Results: </strong>The common histopathologic manifestations of immune checkpoint inhibitor-related colitis are acute active colitis, chronic active colitis, microscopic colitis (collagenous or lymphocytic), and ischemic colitis, with patterns overlapping. Notably, enterocyte apoptosis is a unique feature of immune checkpoint inhibitor toxicity. The proposed mechanisms for the pathogenesis of immune checkpoint inhibitor-related colitis are primarily associated with autoimmune-type dysregulation and gut microbiome alteration. This review summarizes the clinical and pathologic characteristics of immune checkpoint inhibitor-related colitis and elucidates its underlying pathogenic mechanisms.</p><p><strong>Conclusions: </strong>Future successful management of this form of colitis relies on our comprehension of the intricate interplay between tumoral and systemic immune responses to immune checkpoint inhibitors and innovative approaches to modify these responses, along with specific immune cell populations, to preclude immune-related adverse events while achieving antitumor therapeutic outcomes.</p>","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911848","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}