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Lymphangioleiomyomatosis: A Review. 淋巴管瘤病:综述。
Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0206-RA
Mohammed Amine Bouanzoul, Yale Rosen

Context.—: Lymphangioleiomyomatosis is a rare multisystem disorder belonging to the family of neoplasms exhibiting perivascular epithelioid differentiation. It primarily affects women of childbearing age. The disease is characterized by a proliferation of smooth muscle-like cells (lymphangioleiomyomatosis cells) within all lung compartments, leading to cystic parenchymal destruction and, in some cases, respiratory failure. These cells carry mutations in one or both tuberous sclerosis (TSC) genes and coexpress smooth muscle and melanocytic markers. Female hormones, particularly estrogens, influence the course of the disease. Symptoms of lymphangioleiomyomatosis vary significantly among patients, ranging from exertional dyspnea and coughing to chest pain and recurrent pneumothorax.

Objective.—: To present the latest advancements in the understanding of disease pathogenesis and diagnosis, illustrate the pathologic and radiologic findings, provide a reference for pathologists and other health care professionals, briefly discuss recent evidence-based therapeutic approaches, and emphasize the importance of adopting a multidisciplinary approach to diagnosis and optimization of patient care.

Data sources.—: A comprehensive review of pertinent medical literature published in the last 30 years, focusing on publications written in the English language, was performed.

Conclusions.—: Despite the recent significant advancements in the understanding and management of lymphangioleiomyomatosis, there are still significant gaps in our knowledge of its pathophysiology and the role of the immune system in the genesis and progression of the disease. The current changes in diagnostic algorithms favor the adoption of minimally invasive procedures as the standard of care. As a result, the clinical laboratory will play a larger role in the diagnosis of lymphangioleiomyomatosis, and surgical pathologists will likely be less involved in the diagnosis of pulmonary lymphangioleiomyomatosis than they currently are.

内涵:淋巴管瘤病是一种罕见的多系统疾病,属于血管周围上皮样分化的肿瘤家族。它主要影响育龄妇女。该病的特点是平滑肌样细胞(淋巴管瘤细胞)在肺部各处增生,导致肺实质囊性破坏,在某些情况下还会导致呼吸衰竭。这些细胞携带一个或两个结节性硬化症(TSC)基因突变,共同表达平滑肌和黑色素细胞标记。女性荷尔蒙,尤其是雌激素会影响疾病的进程。淋巴管瘤病的症状因人而异,从劳累性呼吸困难和咳嗽到胸痛和复发性气胸不等:介绍在了解疾病发病机制和诊断方面的最新进展,说明病理学和放射学检查结果,为病理学家和其他医护人员提供参考,简要讨论最新的循证治疗方法,并强调采用多学科方法进行诊断和优化患者护理的重要性:数据来源:对过去 30 年出版的相关医学文献进行了全面回顾,重点是以英语撰写的出版物:尽管近年来对淋巴管瘤病的认识和治疗取得了重大进展,但我们对其病理生理学以及免疫系统在疾病发生和发展过程中的作用的认识仍有很大差距。目前诊断算法的变化有利于采用微创手术作为治疗标准。因此,临床实验室将在淋巴管瘤病的诊断中发挥更大的作用,而外科病理学家在肺淋巴管瘤病的诊断中的参与度可能会比现在低。
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引用次数: 0
Exploring the Incidence of Testicular Neoplasms in the Transgender Population: A Case Series. 探索变性人睾丸肿瘤的发病率:病例系列。
Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0218-OA
Elayna M Shanker, Qinghu Ren, Lee C Zhao, Rachel Bluebond-Langner, Fang-Ming Deng

Context.—: The use of hormonal therapy and gender-affirming surgery in the transgender community has been rising during the last several years. Although it is generally safe, hormonal therapy's link to testicular cancer remains uncertain.

Objective.—: To review the incidence of testicular cancer in specimens from gender-affirming orchiectomies at our institution and evaluate the tumors for histologic and genetic alterations.

Design.—: Pathology reports for gender-affirming orchiectomies (January 1, 2018, to August 1, 2023) were reviewed for testicular neoplasms, with additional analysis for chromosome 12 abnormalities. Incidence and chromosome variations were compared with those in the general population.

Results.—: Among 458 cases during 5.5 years, 5 germ cell neoplasms in 4 patients emerged. Our institution's annual incidence rate (159 per 100 000) is 26.5 times higher than the National Cancer Institute's previous report (6.0 per 100 000). Although they were morphologically no different from germ cell neoplasms in the general population, fluorescence in situ hybridization tests showed no i(12p) in 4 of 5 neoplasms (80%) in our cohort.

Conclusions.—: The cause behind this rise in incidence remains uncertain but may be due to long term pretreatment with hormones or blockers. The lower isochromosome 12p frequency suggests an alternative mechanism driving tumor development, which requires more detailed molecular studies.

背景在过去几年中,变性人群体中使用激素疗法和性别确认手术的人数不断增加。尽管激素疗法总体上是安全的,但它与睾丸癌的关系仍不确定:回顾我院性别确认睾丸切除术标本中睾丸癌的发病率,并评估肿瘤的组织学和遗传学改变:对性别确认睾丸切除术(2018年1月1日至2023年8月1日)的病理报告进行了睾丸肿瘤审查,并对12号染色体异常进行了额外分析。将发病率和染色体变异情况与普通人群进行了比较:在5年半的458例病例中,有4名患者罹患5种生殖细胞肿瘤。我院的年发病率(159/10 万)是美国国家癌症研究所之前报告(6.0/10 万)的 26.5 倍。虽然这些肿瘤在形态上与普通人群中的生殖细胞瘤无异,但荧光原位杂交检测显示,在我们的队列中,5 个肿瘤中有 4 个(80%)没有 i(12p):结论:发病率上升的原因尚不明确,但可能与长期使用激素或阻断剂预处理有关。较低的 12p 染色体同工酶频率表明,肿瘤发生有另一种机制,需要进行更详细的分子研究。
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引用次数: 0
Global Pathology: A Snapshot of the Problems, the Progress, and the Potential. 全球病理学:问题、进展和潜力掠影》。
Pub Date : 2024-11-11 DOI: 10.5858/arpa.2024-0183-RA
Andria Chada, Aisha Jibril Suleiman, Zewditu Chanyalew, Lewis Hassell, Bereket Berhane Woldeab, Giorgis Yeabo, Dana Razzano

Context.—: For equitable global health care, the United Nations has outlined Sustainable Development Goals for health in low-income and middle-income countries (LMICs) with the goal of reaching universal health care by 2030. Currently, 47% of the global population lacks access to basic diagnostics for many common diseases. The need for diagnostic access has never been more critical owing to the dramatic rise of noncommunicable diseases in LMICS. In a recent analysis, The Lancet Commission on Diagnostics estimated that 1.1 million deaths occurring on an annual basis could be avoided if the diagnostic gap were reduced to 10% for only 6 priority conditions.

Objective.—: To provide a nonexhaustive summary of the progress made to overcome the barriers to adequate access and explore the potential solutions needed to achieve global diagnostic equity.

Data sources.—: Several experts in global pathology were interviewed in addition to pathologists working in low-resource settings outside of the United States. Published literature on the topic of global pathology work was analyzed and summarized to provide a cohesive snapshot of the status of global pathology.

Conclusions.—: Working to increase access to diagnostics in low-resource settings will save millions of lives. The solution to the current inadequate availability of global pathology services will require a global commitment from the entire pathology and laboratory medicine community, government support, and collaboration between the public-private sectors to achieve equitable health care.

背景为了实现公平的全球医疗保健,联合国为低收入和中等收入国家(LMICs)的医疗保健制定了可持续发展目标,目标是到 2030 年实现全民医疗保健。目前,全球 47% 的人口无法获得许多常见疾病的基本诊断。由于非传染性疾病在低收入和中等收入国家急剧增加,对诊断服务的需求从未像现在这样迫切。柳叶刀诊断委员会在最近的一项分析中估计,如果仅将 6 种重点疾病的诊断差距缩小到 10%,每年就可避免 110 万人死亡:数据来源:对全球病理学领域的多位专家进行了访谈:除了在美国以外的低资源环境中工作的病理学家外,还采访了几位全球病理学专家。对已发表的有关全球病理学工作主题的文献进行了分析和总结,从而为全球病理学的现状提供了一个具有凝聚力的缩影:结论:努力提高低资源环境中诊断的可及性将挽救数百万人的生命。要解决目前全球病理学服务不足的问题,需要整个病理学和实验室医学界做出全球性承诺,需要政府的支持,也需要公私部门的合作,以实现公平的医疗保健。
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引用次数: 0
Adherence to Synoptic Cancer Pathology Reporting Among Pathologists in the National Department of Veterans Affairs Health Care System. 国家退伍军人事务部医疗保健系统病理学家对癌症病理同步报告的遵守情况。
Pub Date : 2024-11-08 DOI: 10.5858/arpa.2024-0229-OA
Abdol Aziz Ould Ismail, Soham Kale, Kathryn McGonagle, Brent Hill, Jason R Pettus, Scott L DuVall, Jeffrey P Ferraro, Florian R Schroeck

Context.—: Quality communication between clinicians and pathologists is required for optimal cancer care. The College of American Pathologists provides anatomic site-specific cancer protocols that facilitate synoptic reporting for efficient communication, contributing to accuracy and completeness of cancer staging.

Objective.—: To evaluate synoptic cancer pathology reporting across the Department of Veterans Affairs (VA), the largest integrated health system in the United States, for 4 common cancers: melanoma and colon, bladder, and kidney cancer.

Design.—: For each cancer type, we investigated at least 200 biopsy and 200 resection reports from 2019 to 2021. In each report, we determined whether a synoptic format was used. The reports were selected using random sampling across all VA health care facilities. We also identified a set of core elements that were underdocumented.

Results.—: Among 1618 pathology reports, 778 (48%; 95% CI, 46%-50%) were synoptic reports. Synoptic reporting was much more common among resections (621 of 811; 77%; 95% CI, 74%-79%) than among biopsies (157 of 807; 19%; 95% CI, 17%-22%). It was most common in colorectal resections (200 of 206; 97%; 95% CI, 94%-99%) and least common in colon biopsy reports (1 of 200; 0.5%; 95% CI, 0%-3%). Core elements that were underdocumented included procedure and regional lymph nodes for resections of bladder and kidney cancer and of melanoma.

Conclusions.—: Synoptic reporting was used about three-quarters of the time for resections and about 1 in 5 times for biopsies. Future work should develop implementation strategies to improve synoptic reporting, especially for biopsy specimens and core elements that were relatively underdocumented.

背景临床医生和病理学家之间需要进行高质量的沟通,以获得最佳的癌症治疗效果。美国病理学家学会(College of American Pathologists)提供了针对特定解剖部位的癌症协议,这些协议有助于同步报告,从而实现高效沟通,提高癌症分期的准确性和完整性:评估美国退伍军人事务部(VA)(美国最大的综合医疗系统)对 4 种常见癌症(黑色素瘤、结肠癌、膀胱癌和肾癌)的同步癌症病理报告:对于每种癌症类型,我们调查了 2019 年至 2021 年期间至少 200 份活检报告和 200 份切除报告。在每份报告中,我们都确定是否使用了综述格式。这些报告是在退伍军人事务部所有医疗机构中随机抽样选出的。我们还确定了一组记录不足的核心要素:在 1618 份病理报告中,778 份(48%;95% CI,46%-50%)是综合报告。切除病理报告(811 份中有 621 份;77%;95% CI,74%-79%)比活检病理报告(807 份中有 157 份;19%;95% CI,17%-22%)更常见。这种情况在结直肠切除术中最常见(206 例中有 200 例;97%;95% CI,94%-99%),在结肠活检报告中最少见(200 例中有 1 例;0.5%;95% CI,0%-3%)。记录不足的核心要素包括膀胱癌、肾癌和黑色素瘤切除术的过程和区域淋巴结:结论:切除术中约有四分之三的时间使用了同步报告,活检中约有五分之一的时间使用了同步报告。今后的工作应制定实施策略,以改进同步报告,尤其是对活检标本和核心要素的记录相对较少。
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引用次数: 0
Correlation of Serum Galactose-Deficient IgA1 and Oxford Class in Cases of IgA Nephropathy. IgA 肾病病例血清缺失半乳糖 IgA1 与牛津分级的相关性
Pub Date : 2024-11-01 DOI: 10.5858/arpa.2023-0190-OA
Monika Shukla, Kiran Preet Malhotra, Abhilash Chandra, Namrata Sarvepalli Rao, Mohammad Kaleem Ahmad

Context.—: Galactose-deficient immunoglobulin A1 (Gd-IgA1) deposition in the renal mesangium plays a role in the pathogenesis of IgA nephropathy.

Objective.—: To assess the serum Gd-IgA1 level in biopsy-proven IgA nephropathy cases at diagnosis and 3 months post treatment and its relation with histologic Oxford classification.

Design.—: In this hospital-based prospective cohort study, 40 cases and 20 controls were enrolled. Serum samples of biopsy-proven IgA nephropathy cases collected on the day of biopsy and 3 months post treatment were evaluated. Solid-phase ELISA (enzyme-linked immunosorbent assay) was performed for assessment of Gd-IgA1 level. All renal biopsies were scored by using the Oxford classification (C-MEST score). The association of serum Gd-IgA1 levels with other established prognostic parameters was assessed. To estimate the prognostic value of markers, logistic regression analysis and Kruskal-Wallis ANOVA (analysis of variance) were used.

Results.—: A significant difference was observed in the serum Gd-IgA1 level values in the IgA nephropathy cases and healthy controls (P = .001) at baseline. However, no significant correlation between serum Gd-IgA1 levels at baseline and 3 months of follow-up (P = .31) or between baseline levels and age, proteinuria, hematuria, or estimated glomerular filtration rate was noted. There was no significant correlation between C-MEST score and serum Gd-IgA1 levels at baseline (P > .05); however, the distribution of Gd-IgA1 at 3 months was found to differ significantly between different grades of S score (P = .008).

Conclusions.—: Serum Gd-IgA1 levels may be of utility in predicting disease progression in IgA nephropathy cases. Measurement of serum Gd-IgA1 levels for the diagnosis and prognosis of IgA nephropathy may preclude the need for invasive renal biopsies.

背景在IgA肾病的发病机制中,肾间质中的半乳糖缺乏性免疫球蛋白A1(Gd-IgA1)沉积起了一定作用:评估活检证实的IgA肾病病例在确诊时和治疗后3个月的血清Gd-IgA1水平及其与组织学牛津分类的关系:在这项基于医院的前瞻性队列研究中,共纳入了 40 例病例和 20 例对照。对活检证实的 IgA 肾病病例在活检当天和治疗后 3 个月采集的血清样本进行了评估。固相酶联免疫吸附试验(ELISA)用于评估 Gd-IgA1 水平。所有肾活检均采用牛津分类法(C-MEST 评分)进行评分。评估了血清 Gd-IgA1 水平与其他既定预后参数的关联。为估算指标的预后价值,采用了逻辑回归分析和 Kruskal-Wallis ANOVA(方差分析):IgA肾病病例和健康对照组的血清Gd-IgA1水平在基线值上存在显著差异(P = .001)。然而,基线和随访 3 个月的血清 Gd-IgA1 水平之间(P = .31)或基线水平与年龄、蛋白尿、血尿或估计肾小球滤过率之间均无明显相关性。C-MEST评分与基线时的血清Gd-IgA1水平之间无明显相关性(P > .05);但3个月时的Gd-IgA1分布在S评分的不同等级之间存在明显差异(P = .008):结论:血清 Gd-IgA1 水平可能有助于预测 IgA 肾病病例的病情发展。测量血清 Gd-IgA1 水平用于 IgA 肾病的诊断和预后可避免进行侵入性肾活检。
{"title":"Correlation of Serum Galactose-Deficient IgA1 and Oxford Class in Cases of IgA Nephropathy.","authors":"Monika Shukla, Kiran Preet Malhotra, Abhilash Chandra, Namrata Sarvepalli Rao, Mohammad Kaleem Ahmad","doi":"10.5858/arpa.2023-0190-OA","DOIUrl":"10.5858/arpa.2023-0190-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Galactose-deficient immunoglobulin A1 (Gd-IgA1) deposition in the renal mesangium plays a role in the pathogenesis of IgA nephropathy.</p><p><strong>Objective.—: </strong>To assess the serum Gd-IgA1 level in biopsy-proven IgA nephropathy cases at diagnosis and 3 months post treatment and its relation with histologic Oxford classification.</p><p><strong>Design.—: </strong>In this hospital-based prospective cohort study, 40 cases and 20 controls were enrolled. Serum samples of biopsy-proven IgA nephropathy cases collected on the day of biopsy and 3 months post treatment were evaluated. Solid-phase ELISA (enzyme-linked immunosorbent assay) was performed for assessment of Gd-IgA1 level. All renal biopsies were scored by using the Oxford classification (C-MEST score). The association of serum Gd-IgA1 levels with other established prognostic parameters was assessed. To estimate the prognostic value of markers, logistic regression analysis and Kruskal-Wallis ANOVA (analysis of variance) were used.</p><p><strong>Results.—: </strong>A significant difference was observed in the serum Gd-IgA1 level values in the IgA nephropathy cases and healthy controls (P = .001) at baseline. However, no significant correlation between serum Gd-IgA1 levels at baseline and 3 months of follow-up (P = .31) or between baseline levels and age, proteinuria, hematuria, or estimated glomerular filtration rate was noted. There was no significant correlation between C-MEST score and serum Gd-IgA1 levels at baseline (P > .05); however, the distribution of Gd-IgA1 at 3 months was found to differ significantly between different grades of S score (P = .008).</p><p><strong>Conclusions.—: </strong>Serum Gd-IgA1 levels may be of utility in predicting disease progression in IgA nephropathy cases. Measurement of serum Gd-IgA1 levels for the diagnosis and prognosis of IgA nephropathy may preclude the need for invasive renal biopsies.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"1244-1250"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139577125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine. 开发米韦妥昔单抗索拉坦星的 FRα 辅助诊断免疫组化测定。
Pub Date : 2024-11-01 DOI: 10.5858/arpa.2023-0149-OA
Racheal L James, Taryn Sisserson, Zhuangyu Cai, Megan E Dumas, Landon J Inge, James Ranger-Moore, Albert Mason, Callum M Sloss, Katherine McArthur

Context.—: Folate receptor-α (FRα, encoded by the FOLR1 gene) is overexpressed in several solid tumor types, including epithelial ovarian cancer (EOC), making it an attractive biomarker and target for FRα-based therapy in ovarian cancer.

Objective.—: To describe the development, analytic verification, and clinical performance of the VENTANA FOLR1 Assay (Ventana Medical Systems Inc) in EOC.

Design.—: We used industry standard studies to establish the analytic verification of the VENTANA FOLR1 Assay. Furthermore, the VENTANA FOLR1 Assay was used in the ImmunoGen Inc-sponsored SORAYA study to select patients for treatment with mirvetuximab soravtansine (MIRV) in platinum-resistant EOC.

Results.—: The VENTANA FOLR1 Assay is highly reproducible, demonstrated by a greater than 98% overall percent agreement (OPA) for repeatability and intermediate precision studies, greater than 93% OPA for interreader and greater than 96% for intrareader studies, and greater than 90% OPA across all observations in the interlaboratory reproducibility study. The performance of the VENTANA FOLR1 Assay in the SORAYA study was evaluated by the overall staining acceptability rate, which was calculated using the number of patient specimens that were tested with the VENTANA FOLR1 Assay that had an evaluable result. In the SORAYA trial, data in patients who received MIRV demonstrated clinically meaningful efficacy, and the overall staining acceptability rate of the assay was 98.4%, demonstrating that the VENTANA FOLR1 Assay is safe and effective for selecting patients who may benefit from MIRV. Together, these data showed that the assay is highly reliable, consistently producing evaluable results in the clinical setting.

Conclusions.—: The VENTANA FOLR1 Assay is a robust and reproducible assay for detecting FRα expression and identifying a patient population that derived clinically meaningful benefit from MIRV in the SORAYA study.

背景叶酸受体-α(FRα,由 FOLR1 基因编码)在包括上皮性卵巢癌(EOC)在内的几种实体瘤类型中过度表达,使其成为一种有吸引力的生物标记物和基于 FRα 的卵巢癌治疗靶点:描述 VENTANA FOLR1 检测试剂盒(Ventana Medical Systems Inc)在 EOC 中的开发、分析验证和临床表现:我们采用行业标准研究来确定 VENTANA FOLR1 检测试剂盒的分析验证。此外,VENTANA FOLR1检测法还被用于ImmunoGen公司赞助的SORAYA研究,以选择接受米韦曲单抗(MIRV)治疗的铂类耐药EOC患者:VENTANA FOLR1测定的可重复性很高,这体现在重复性和中间精度研究的总百分数一致率(OPA)超过98%,读数器间研究的OPA超过93%,读数器内研究的OPA超过96%,实验室间可重复性研究中所有观察指标的OPA超过90%。在 SORAYA 研究中,VENTANA FOLR1 检测试剂盒的性能是通过总体染色可接受性率来评估的,而总体染色可接受性率是通过使用 VENTANA FOLR1 检测试剂盒检测并得出可评估结果的患者标本数量来计算的。在 SORAYA 试验中,接受 MIRV 治疗的患者的数据显示出了有临床意义的疗效,该检测方法的总体染色可接受性为 98.4%,这表明 VENTANA FOLR1 检测方法在选择可能从 MIRV 中获益的患者方面是安全有效的。这些数据共同表明,该检测方法非常可靠,能在临床环境中持续产生可评估的结果:VENTANA FOLR1 检测试剂盒是一种稳健且可重复的检测试剂盒,可用于检测 FRα 的表达,并在 SORAYA 研究中确定可从 MIRV 中获得有临床意义的获益的患者群体。
{"title":"Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine.","authors":"Racheal L James, Taryn Sisserson, Zhuangyu Cai, Megan E Dumas, Landon J Inge, James Ranger-Moore, Albert Mason, Callum M Sloss, Katherine McArthur","doi":"10.5858/arpa.2023-0149-OA","DOIUrl":"10.5858/arpa.2023-0149-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Folate receptor-α (FRα, encoded by the FOLR1 gene) is overexpressed in several solid tumor types, including epithelial ovarian cancer (EOC), making it an attractive biomarker and target for FRα-based therapy in ovarian cancer.</p><p><strong>Objective.—: </strong>To describe the development, analytic verification, and clinical performance of the VENTANA FOLR1 Assay (Ventana Medical Systems Inc) in EOC.</p><p><strong>Design.—: </strong>We used industry standard studies to establish the analytic verification of the VENTANA FOLR1 Assay. Furthermore, the VENTANA FOLR1 Assay was used in the ImmunoGen Inc-sponsored SORAYA study to select patients for treatment with mirvetuximab soravtansine (MIRV) in platinum-resistant EOC.</p><p><strong>Results.—: </strong>The VENTANA FOLR1 Assay is highly reproducible, demonstrated by a greater than 98% overall percent agreement (OPA) for repeatability and intermediate precision studies, greater than 93% OPA for interreader and greater than 96% for intrareader studies, and greater than 90% OPA across all observations in the interlaboratory reproducibility study. The performance of the VENTANA FOLR1 Assay in the SORAYA study was evaluated by the overall staining acceptability rate, which was calculated using the number of patient specimens that were tested with the VENTANA FOLR1 Assay that had an evaluable result. In the SORAYA trial, data in patients who received MIRV demonstrated clinically meaningful efficacy, and the overall staining acceptability rate of the assay was 98.4%, demonstrating that the VENTANA FOLR1 Assay is safe and effective for selecting patients who may benefit from MIRV. Together, these data showed that the assay is highly reliable, consistently producing evaluable results in the clinical setting.</p><p><strong>Conclusions.—: </strong>The VENTANA FOLR1 Assay is a robust and reproducible assay for detecting FRα expression and identifying a patient population that derived clinically meaningful benefit from MIRV in the SORAYA study.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":"1226-1233"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Comparison Between Immunohistochemistry and mRNA Expression to Identify Human Epidermal Growth Factor Receptor 2-Low Breast Cancer. 免疫组织化学与 mRNA 表达的比较,以鉴别人类表皮生长因子受体 2 低水平乳腺癌。
Pub Date : 2024-10-30 DOI: 10.5858/arpa.2024-0255-OA
Ximena Baez-Navarro, Mieke R van Bockstal, Angelique van der Made, Carolien H M van Deurzen

Context.—: Breast cancers (BCs) with low levels of human epidermal growth factor receptor 2 (HER2) expression (HER2-low) have become a targetable subset because of novel antibody-drug conjugates. HER2 immunohistochemistry (IHC) is the recommended assay for HER2 classification but is associated with limited interobserver agreement concerning HER2-low identification.

Objective.—: To investigate whether mRNA expression quantified via quantitative reverse transcription-polymerase chain reaction (RT-qPCR) could serve as a valuable complementary and more objective method to identify HER2-low BCs.

Design.—: We selected all cases from a previously published interobserver study, which included 105 needle biopsies from HER2 nonamplified BC cases. HER2 IHC was evaluated by 16 pathologists. For the current study, mRNA was extracted from microdissected invasive tumor cells. RT-qPCR was performed for quantitative evaluation of HER2, using the cutoff values of the MammaTyper assay. We compared the mRNA expression levels with the IHC scores of the majority agreement (IHC 0, IHC >0, <1+ [ultralow], 1+, 2+) and the following HER2 subcategories: HER2 0/ultralow and HER2-low (IHC 1+ and 2+/fluorescence in situ hybridization negative).

Results.—: In total, 88 nonamplified HER2 cases could be analyzed. Based on IHC, 17 cases were HER2 0/ultralow and 71 were HER2-low. The mean rank HER2 mRNA level was significantly higher in HER2-low cases than in the HER2 0/ultralow group (P < .001). However, 10 of 17 HER2 0/ultralow cases by IHC (58.8%) were classified as HER2-low by MammaTyper, 2 of 71 cases (2.8%) were HER2-low by IHC and HER2 0/ultralow by MammaTyper, and 2 (2.8%) were HER2-low by IHC and HER2-positive by RP-qPCR.

Conclusions.—: Our findings indicate a strong agreement between mRNA expression quantified by RT-qPCR and HER2 IHC scores, although there was a substantial proportion of discordant HER2 results between both methods owing to overestimation of HER2 expression by MammaTyper compared to IHC. Future large-scale trials should determine which technique is best associated with clinical outcome.

背景由于新型抗体-药物共轭物的出现,人表皮生长因子受体 2(HER2)表达水平较低(HER2-low)的乳腺癌(BCs)已成为一个靶向亚群。HER2免疫组化(IHC)是HER2分类的推荐检测方法,但在HER2-low的识别方面,观察者之间的一致性有限:研究通过定量反转录聚合酶链反应(RT-qPCR)量化的 mRNA 表达是否可作为一种有价值的补充和更客观的方法来识别 HER2 低的 BC:我们从先前发表的一项观察者间研究中选取了所有病例,其中包括 105 例 HER2 非扩增 BC 的针刺活检。16 位病理学家对 HER2 IHC 进行了评估。在本次研究中,我们从显微解剖的浸润性肿瘤细胞中提取了 mRNA。使用 MammaTyper 检测法的临界值进行 RT-qPCR 检测,对 HER2 进行定量评估。我们将 mRNA 表达水平与多数人同意的 IHC 评分(IHC 0、IHC >0、Results.-)进行了比较:共分析了 88 例非扩增 HER2 病例。根据 IHC,17 例为 HER2 0/超低,71 例为 HER2 低。HER2 低水平病例的 HER2 mRNA 平均水平明显高于 HER2 0/ultralow 组(P < .001)。然而,通过 IHC 检测的 17 例 HER2 0/ultralow 病例中有 10 例(58.8%)通过 MammaTyper 被归类为 HER2-low,71 例病例中有 2 例(2.8%)通过 IHC 检测为 HER2-low,通过 MammaTyper 检测为 HER2 0/ultralow,2 例(2.8%)通过 IHC 检测为 HER2-low,通过 RP-qPCR 检测为 HER2 阳性:我们的研究结果表明,RT-qPCR 定量的 mRNA 表达与 HER2 IHC 评分之间存在很高的一致性,但由于 MammaTyper 与 IHC 相比高估了 HER2 的表达,因此两种方法的 HER2 结果有很大一部分不一致。未来的大规模试验应确定哪种技术与临床结果最相关。
{"title":"A Comparison Between Immunohistochemistry and mRNA Expression to Identify Human Epidermal Growth Factor Receptor 2-Low Breast Cancer.","authors":"Ximena Baez-Navarro, Mieke R van Bockstal, Angelique van der Made, Carolien H M van Deurzen","doi":"10.5858/arpa.2024-0255-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0255-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Breast cancers (BCs) with low levels of human epidermal growth factor receptor 2 (HER2) expression (HER2-low) have become a targetable subset because of novel antibody-drug conjugates. HER2 immunohistochemistry (IHC) is the recommended assay for HER2 classification but is associated with limited interobserver agreement concerning HER2-low identification.</p><p><strong>Objective.—: </strong>To investigate whether mRNA expression quantified via quantitative reverse transcription-polymerase chain reaction (RT-qPCR) could serve as a valuable complementary and more objective method to identify HER2-low BCs.</p><p><strong>Design.—: </strong>We selected all cases from a previously published interobserver study, which included 105 needle biopsies from HER2 nonamplified BC cases. HER2 IHC was evaluated by 16 pathologists. For the current study, mRNA was extracted from microdissected invasive tumor cells. RT-qPCR was performed for quantitative evaluation of HER2, using the cutoff values of the MammaTyper assay. We compared the mRNA expression levels with the IHC scores of the majority agreement (IHC 0, IHC >0, <1+ [ultralow], 1+, 2+) and the following HER2 subcategories: HER2 0/ultralow and HER2-low (IHC 1+ and 2+/fluorescence in situ hybridization negative).</p><p><strong>Results.—: </strong>In total, 88 nonamplified HER2 cases could be analyzed. Based on IHC, 17 cases were HER2 0/ultralow and 71 were HER2-low. The mean rank HER2 mRNA level was significantly higher in HER2-low cases than in the HER2 0/ultralow group (P < .001). However, 10 of 17 HER2 0/ultralow cases by IHC (58.8%) were classified as HER2-low by MammaTyper, 2 of 71 cases (2.8%) were HER2-low by IHC and HER2 0/ultralow by MammaTyper, and 2 (2.8%) were HER2-low by IHC and HER2-positive by RP-qPCR.</p><p><strong>Conclusions.—: </strong>Our findings indicate a strong agreement between mRNA expression quantified by RT-qPCR and HER2 IHC scores, although there was a substantial proportion of discordant HER2 results between both methods owing to overestimation of HER2 expression by MammaTyper compared to IHC. Future large-scale trials should determine which technique is best associated with clinical outcome.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificial Intelligence-Assisted Daily Quality Control System for the Histologic Diagnosis of Gastrointestinal Endoscopic Biopsies: A 1-Year Experience. 人工智能辅助胃肠道内窥镜活检组织学诊断日常质量控制系统:一年的经验。
Pub Date : 2024-10-25 DOI: 10.5858/arpa.2024-0173-OA
Seung-Yeon Yoo, Yuri Hwang, Seokju Yun, Ok Hee Lee, Jiwook Jang, Youngjin Park, Tae Young Cho, Young Sin Ko

Context.—: Seegene Medical Foundation, one of the major clinical laboratories in South Korea, developed SeeDP, an artificial intelligence (AI)-based postanalytic daily quality control (QC) system that reassesses all gastrointestinal (GI) endoscopic biopsy (EB) slides for incorrect diagnoses.

Objective.—: To review the operational records and clinical impact of SeeDP since its launch in March 2022.

Design.—: Operational records of SeeDP were retrieved for the period of March 1, 2022, to February 28, 2023. Among cases scanned during 40 working days (March 10, 2022, to May 4, 2022), all discordant cases encountered by 2 pathologists were reviewed. Cases of SeeDP-assisted revised diagnoses were collected and compared with cases recognized using conventional methods.

Results.—: Occasional scanner failures and various types of aberrant errors compromised QC coverage, resulting in the scanning of only 67.7% (572 254 of 844 906) of all EB slides submitted and 0.8% of the scanned slides being further excluded from the AI analysis. The AI predictions differed from the pathologists' diagnoses in 42 760 of the 557 672 gastrointestinal EB slides (7.7%) successfully assessed by the AI models; however, a detailed review of discordant slides revealed that true misdiagnosis accounted for only 5.5% (25 of 454) of the disagreements. Compared with conventional error recognition methods, SeeDP detected more misdiagnoses (7 versus 14) within a significantly shorter time (average, 3.6 versus 38.7 days; P < .001), including 1 signet ring cell carcinoma initially diagnosed as gastritis.

Conclusions.—: AI-based daily QC systems are plausible solutions to guarantee high-quality pathologic diagnosis by enabling rapid detection and correction of misdiagnosis.

背景Seegene 医疗基金会是韩国主要的临床实验室之一,它开发了基于人工智能(AI)的分析后日常质量控制(QC)系统 SeeDP,该系统可重新评估所有胃肠道(GI)内窥镜活检(EB)切片的错误诊断:回顾 SeeDP 自 2022 年 3 月启动以来的运行记录和临床影响:检索了2022年3月1日至2023年2月28日期间SeeDP的运行记录。在 40 个工作日(2022 年 3 月 10 日至 2022 年 5 月 4 日)内扫描的病例中,对 2 名病理学家遇到的所有不一致病例进行了审查。收集 SeeDP 辅助修订诊断的病例,并与使用传统方法确认的病例进行比较:扫描仪偶发故障和各种类型的异常错误影响了质控覆盖率,导致提交的所有 EB 切片中仅有 67.7%(844 906 张中的 572 254 张)被扫描,0.8% 的扫描切片被进一步排除在人工智能分析之外。在人工智能模型成功评估的 557 672 张胃肠道 EB 病理切片中,有 42 760 张(7.7%)的人工智能预测与病理学家的诊断存在差异;然而,对不一致病理切片的详细审查显示,真正的误诊仅占不一致病理切片的 5.5%(454 张中的 25 张)。与传统的错误识别方法相比,SeeDP 在更短的时间内(平均 3.6 天对 38.7 天;P < .001)发现了更多的误诊(7 例对 14 例),其中包括 1 例最初诊断为胃炎的印戒细胞癌:基于人工智能的日常质控系统能够快速检测和纠正误诊,是保证高质量病理诊断的可行解决方案。
{"title":"Artificial Intelligence-Assisted Daily Quality Control System for the Histologic Diagnosis of Gastrointestinal Endoscopic Biopsies: A 1-Year Experience.","authors":"Seung-Yeon Yoo, Yuri Hwang, Seokju Yun, Ok Hee Lee, Jiwook Jang, Youngjin Park, Tae Young Cho, Young Sin Ko","doi":"10.5858/arpa.2024-0173-OA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0173-OA","url":null,"abstract":"<p><strong>Context.—: </strong>Seegene Medical Foundation, one of the major clinical laboratories in South Korea, developed SeeDP, an artificial intelligence (AI)-based postanalytic daily quality control (QC) system that reassesses all gastrointestinal (GI) endoscopic biopsy (EB) slides for incorrect diagnoses.</p><p><strong>Objective.—: </strong>To review the operational records and clinical impact of SeeDP since its launch in March 2022.</p><p><strong>Design.—: </strong>Operational records of SeeDP were retrieved for the period of March 1, 2022, to February 28, 2023. Among cases scanned during 40 working days (March 10, 2022, to May 4, 2022), all discordant cases encountered by 2 pathologists were reviewed. Cases of SeeDP-assisted revised diagnoses were collected and compared with cases recognized using conventional methods.</p><p><strong>Results.—: </strong>Occasional scanner failures and various types of aberrant errors compromised QC coverage, resulting in the scanning of only 67.7% (572 254 of 844 906) of all EB slides submitted and 0.8% of the scanned slides being further excluded from the AI analysis. The AI predictions differed from the pathologists' diagnoses in 42 760 of the 557 672 gastrointestinal EB slides (7.7%) successfully assessed by the AI models; however, a detailed review of discordant slides revealed that true misdiagnosis accounted for only 5.5% (25 of 454) of the disagreements. Compared with conventional error recognition methods, SeeDP detected more misdiagnoses (7 versus 14) within a significantly shorter time (average, 3.6 versus 38.7 days; P < .001), including 1 signet ring cell carcinoma initially diagnosed as gastritis.</p><p><strong>Conclusions.—: </strong>AI-based daily QC systems are plausible solutions to guarantee high-quality pathologic diagnosis by enabling rapid detection and correction of misdiagnosis.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neoadjuvant Therapy and Lung Cancer: Role of Pathologists. 新辅助疗法与肺癌:病理学家的作用。
Pub Date : 2024-10-25 DOI: 10.5858/arpa.2024-0203-RA
Sanja Dacic

Context.—: Recent neoadjuvant clinical trials in lung cancer have demonstrated the survival benefits in carefully selected patients. Standardization of the assessment of pathologic response to neoadjuvant therapy in surgically resected specimens is required.

Objective.—: To review the current pathology practices in the gross processing and microscopic assessment of surgically resected non-small cell lung carcinoma specimens after neoadjuvant therapy.

Data sources.—: PubMed publications and experience of the author.

Conclusions.—: Gross processing of the surgically resected lung carcinoma after neoadjuvant therapy needs further refinement and standardization in clinical trials and in a real-world clinical practice. Microscopic assessment of the response includes quantification of viable tumor, necrosis, and stroma. The best approach would be to use a single standardized and most reproducible scoring system. Published studies on gross processing of lung carcinoma specimens in the neoadjuvant setting and microscopic assessment of pathologic response provide a good foundation for the future standardization of pathology practice.

背景最近的肺癌新辅助治疗临床试验表明,经过严格筛选的患者可获得生存益处。需要对手术切除标本的新辅助治疗病理反应进行标准化评估:回顾目前病理学对新辅助治疗后手术切除的非小细胞肺癌标本进行大体处理和显微镜评估的做法:论文发表和作者的经验:新辅助治疗后手术切除肺癌的大体处理需要在临床试验和实际临床实践中进一步完善和标准化。对反应的显微评估包括存活肿瘤、坏死和基质的量化。最好的方法是使用单一的标准化和可重复性最高的评分系统。已发表的关于新辅助治疗中肺癌标本大体处理和病理反应显微评估的研究为未来病理实践的标准化奠定了良好的基础。
{"title":"Neoadjuvant Therapy and Lung Cancer: Role of Pathologists.","authors":"Sanja Dacic","doi":"10.5858/arpa.2024-0203-RA","DOIUrl":"https://doi.org/10.5858/arpa.2024-0203-RA","url":null,"abstract":"<p><strong>Context.—: </strong>Recent neoadjuvant clinical trials in lung cancer have demonstrated the survival benefits in carefully selected patients. Standardization of the assessment of pathologic response to neoadjuvant therapy in surgically resected specimens is required.</p><p><strong>Objective.—: </strong>To review the current pathology practices in the gross processing and microscopic assessment of surgically resected non-small cell lung carcinoma specimens after neoadjuvant therapy.</p><p><strong>Data sources.—: </strong>PubMed publications and experience of the author.</p><p><strong>Conclusions.—: </strong>Gross processing of the surgically resected lung carcinoma after neoadjuvant therapy needs further refinement and standardization in clinical trials and in a real-world clinical practice. Microscopic assessment of the response includes quantification of viable tumor, necrosis, and stroma. The best approach would be to use a single standardized and most reproducible scoring system. Published studies on gross processing of lung carcinoma specimens in the neoadjuvant setting and microscopic assessment of pathologic response provide a good foundation for the future standardization of pathology practice.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Two Accreditation Options for Biorepositories. 生物资料库的两种认证选择。
Pub Date : 2024-10-23 DOI: 10.5858/arpa.2023-0221-CP
Richard C Davis, Joan Rose, Helena J Ellis, Erik Zmuda, Nalin Leelatian, Thomas Summers, Rebecca Obeng, Jim Vaught, Nilsa C Ramirez, Shannon J McCall

Context.—: Biomedical research relies on available biomaterials and associated data, and the quality of this starting material can have a significant impact on the quality of the experimental results. In the 2000s, best-practice documents and guidelines for biorepositories were published, followed in the 2010s by standards documents used to support accreditation. The College of American Pathologists Biorepository Accreditation Program and the International Standards Organization's standard 20387 were launched in 2012 and 2018, respectively.

Objective.—: To identify quantitative and qualitative differences between the two aforementioned biorepository accreditation standards for use by the larger biomedical research community; the results will empower biorepositories to select an accreditation program that best fits their goals.

Design.—: Individual requirements of both accreditation standards were identified and a bidirectional crosswalk was performed to identify gaps. Requirements were assigned to one of several standardized categories to enable comparison of the relative emphasis of different categories between the standards.

Results.—: Quantitatively, the College of American Pathologists program is comprehensive and stands alone, with 523 requirements, whereas the International Standards Organization program contains 167 requirements and is comprehensive through its incorporation and reference to numerous related standards documents. Qualitatively, both programs rely heavily on the implementation of an overarching quality management system and both programs can accommodate different types of biobanks (eg, human and animal).

Conclusions.—: The standards differ in number of requirements, distribution of requirements across categories, and amount of reliance on separate standard documents. This information may aid in selection of an appropriate accreditation standard.

背景生物医学研究依赖于可用的生物材料和相关数据,这些初始材料的质量会对实验结果的质量产生重大影响。2000 年代,生物库的最佳实践文件和指南相继出版,2010 年代又出版了用于支持认证的标准文件。美国病理学家学会生物库认证计划和国际标准化组织的 20387 标准分别于 2012 年和 2018 年推出:确定上述两个生物库认证标准的定量和定性差异,供更广泛的生物医学研究界使用;结果将使生物库能够选择最适合其目标的认证计划:设计:确定了两个认证标准中的个别要求,并进行了双向对照,以找出差距。要求被归入几个标准化类别之一,以便比较不同标准对不同类别的相对重视程度:从数量上看,美国病理学家学会的计划全面而独立,有 523 项要求,而国际标准化组织的计划则包含 167 项要求,并通过纳入和参考众多相关标准文件而变得全面。从质量上讲,这两项计划都非常依赖于总体质量管理体系的实施,而且这两项计划都能适应不同类型的生物库(如人类和动物):结论:这两项标准在要求数量、不同类别要求的分布以及对不同标准文件的依赖程度方面存在差异。这些信息有助于选择合适的认证标准。
{"title":"Two Accreditation Options for Biorepositories.","authors":"Richard C Davis, Joan Rose, Helena J Ellis, Erik Zmuda, Nalin Leelatian, Thomas Summers, Rebecca Obeng, Jim Vaught, Nilsa C Ramirez, Shannon J McCall","doi":"10.5858/arpa.2023-0221-CP","DOIUrl":"https://doi.org/10.5858/arpa.2023-0221-CP","url":null,"abstract":"<p><strong>Context.—: </strong>Biomedical research relies on available biomaterials and associated data, and the quality of this starting material can have a significant impact on the quality of the experimental results. In the 2000s, best-practice documents and guidelines for biorepositories were published, followed in the 2010s by standards documents used to support accreditation. The College of American Pathologists Biorepository Accreditation Program and the International Standards Organization's standard 20387 were launched in 2012 and 2018, respectively.</p><p><strong>Objective.—: </strong>To identify quantitative and qualitative differences between the two aforementioned biorepository accreditation standards for use by the larger biomedical research community; the results will empower biorepositories to select an accreditation program that best fits their goals.</p><p><strong>Design.—: </strong>Individual requirements of both accreditation standards were identified and a bidirectional crosswalk was performed to identify gaps. Requirements were assigned to one of several standardized categories to enable comparison of the relative emphasis of different categories between the standards.</p><p><strong>Results.—: </strong>Quantitatively, the College of American Pathologists program is comprehensive and stands alone, with 523 requirements, whereas the International Standards Organization program contains 167 requirements and is comprehensive through its incorporation and reference to numerous related standards documents. Qualitatively, both programs rely heavily on the implementation of an overarching quality management system and both programs can accommodate different types of biobanks (eg, human and animal).</p><p><strong>Conclusions.—: </strong>The standards differ in number of requirements, distribution of requirements across categories, and amount of reliance on separate standard documents. This information may aid in selection of an appropriate accreditation standard.</p>","PeriodicalId":93883,"journal":{"name":"Archives of pathology & laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Archives of pathology & laboratory medicine
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