定量成像分析荧光原位杂交验证乳腺癌临床HER2检测。

IF 3.7 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Diane M Wilcock, Kristina H Moore, Leslie Rowe, Jonathan Mahlow, Jolanta Jedrzkiewicz, Allison S Cleary, Lesley Lomo, Ana L Ruano, Maarika Gering, Derek Bradshaw, Meghan Maughan, Phuong Tran, Jesse Burlingame, Richard Davis, Kajsa Affolter, Daniel J Albertson, Parisa Adelhardt, Jong Take Kim, Joshua F Coleman, Georgios Deftereos, Evin H Gulbahce, Deepika Sirohi
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引用次数: 0

摘要

上下文。定量成像是一种很有前途的工具,在病理学的几个领域得到了广泛的应用。尽管越来越多地采用形态学和免疫组织化学分析,但由于复杂性和缺乏实践指南,荧光原位杂交(FISH)对福尔马林固定石蜡包埋组织的评价受到限制。-:根据美国临床肿瘤学会/美国病理学家学会(ASCO/CAP) 2018指南,在乳腺癌中进行人表皮生长因子受体2 (HER2) FISH验证。-:使用美国食品和药物管理局批准的双探针HER2 IQFISH (Dako, Carpinteria, California)进行HER2 FISH的临床验证,并在PathFusion (Applied Spectral Imaging, Carlsbad, California)系统上进行数字扫描。评估的验证参数包括z堆叠、分类器、准确性、精密度、软件和硬件设置。最后,我们在现实世界中评估了数字枚举在临床样本上的性能。-:准确性样本显示HER2组1至5的最终一致性为95.3%至100%。在HER2组2、3和4的临床实施过程中,我们达到了76%的最终一致性(125例中的95例)。在这些病例中,只有8%(125例中的10例)与临床影响不一致,可以通过算法识别和分类进行人工审查。-:数字FISH枚举是提高HER2 FISH枚举效率和捕获HER2信号遗传异质性的有用工具。排除高背景或图像质量差的病例,手工复查ASCO/CAP组不一致的病例,可以进一步提高HER2 FISH数字计数的效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quantitative Imaging Analysis Fluorescence In Situ Hybridization Validation for Clinical HER2 Testing in Breast Cancer.

Context.—: Quantitative imaging is a promising tool that is gaining wide use across several areas of pathology. Although there has been increasing adoption of morphologic and immunohistochemical analysis, the adoption of evaluation of fluorescence in situ hybridization (FISH) on formalin-fixed, paraffin-embedded tissue has been limited because of complexity and lack of practice guidelines.

Objective.—: To perform human epidermal growth factor receptor 2 (HER2) FISH validation in breast carcinoma in accordance with the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 guideline.

Design.—: Clinical validation of HER2 FISH was performed using the US Food and Drug Administration-approved dual-probe HER2 IQFISH (Dako, Carpinteria, California) with digital scanning performed on a PathFusion (Applied Spectral Imaging, Carlsbad, California) system. Validation parameters evaluated included z-stacking, classifier, accuracy, precision, software, and hardware settings. Finally, we evaluated the performance of digital enumeration on clinical samples in a real-world setting.

Results.—: The accuracy samples showed a final concordance of 95.3% to 100% across HER2 groups 1 to 5. During clinical implementation for HER2 groups 2, 3, and 4, we achieved a final concordance of 76% (95 of 125). Of these cases, only 8% (10 of 125) had discordances with clinical impact that could be identified algorithmically and triaged for manual review.

Conclusions.—: Digital FISH enumeration is a useful tool to improve the efficacy of HER2 FISH enumeration and capture genetic heterogeneity across HER2 signals. Excluding cases with high background or poor image quality and manual review of cases with ASCO/CAP group discordances can further improve the efficiency of digital HER2 FISH enumeration.

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来源期刊
CiteScore
9.20
自引率
2.20%
发文量
369
审稿时长
3-8 weeks
期刊介绍: Welcome to the website of the Archives of Pathology & Laboratory Medicine (APLM). This monthly, peer-reviewed journal of the College of American Pathologists offers global reach and highest measured readership among pathology journals. Published since 1926, ARCHIVES was voted in 2009 the only pathology journal among the top 100 most influential journals of the past 100 years by the BioMedical and Life Sciences Division of the Special Libraries Association. Online access to the full-text and PDF files of APLM articles is free.
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