Comparative study of intra- and inter-observer variability in manual scoring of HER2 immunohistochemical stains on glass slides versus paired digital images with emphasis on the low end of the expression spectrum.

IF 2.7 2区 医学 Q2 PATHOLOGY
Andrew Xiao, Poonam Vohra, Yunn-Yi Chen, Leah Ung, Mi-Ok Kim, Joseph Geradts
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引用次数: 0

Abstract

With the advent of new therapeutic agents showing efficacy in human breast cancers with low levels of the HER2 oncoprotein, it has become important for pathologists to accurately categorize HER2 expression at the low end of the spectrum. At the same time, an increasing number of pathology laboratories are transitioning to a digital workflow. Our study was primarily designed to define inter-observer variability in manual scoring of HER2 stains and to investigate any differences in scoring of glass slides versus paired digital images. We studied 247 breast carcinomas including 117 core biopsies and 130 excisional specimens. Tumors with a HER2 score of 0 were oversampled (n=100) and sub-classified as "null" and "ultralow". Inter-observer agreement was high among three experienced breast pathologists (kappa = 0.82-0.87). Intra-observer agreement for scoring glass slides versus paired digital images also was near perfect (kappa = 0.89-0.98). Discordant reads were noted in 10.1% of slide/image pairs, and in the majority of cases, digital image scores were higher. Most discordances were observed among null and ultralow cases. Consensus scoring of digital images yielded fewer null and more 1+ scores compared to glass slides. Between 25% and 48% of cases with a clinically reported HER2 score of 0 were sub-classified as null. Our study demonstrates that a high level of inter-observer agreement in manual HER2 scoring is achievable, even at the low end of the expression spectrum. Importantly, glass slide and image reads were largely concordant, but digital image scoring may be more sensitive at low immunohistochemical staining levels.

在玻片上手工评分HER2免疫组织化学染色与配对数字图像的观察者内部和观察者之间的可变性的比较研究,重点是表达谱的低端。
随着新的治疗药物对低水平HER2癌蛋白的人乳腺癌的疗效的出现,对病理学家来说,准确地对低水平HER2表达进行分类变得很重要。与此同时,越来越多的病理实验室正在向数字化工作流程过渡。我们的研究主要是为了定义HER2染色人工评分的观察者间可变性,并研究玻片评分与配对数字图像评分的差异。我们研究了247例乳腺癌,包括117例核心活检和130例切除标本。对HER2评分为0的肿瘤进行过采样(n=100),并将其分类为“零”和“超低”。三名经验丰富的乳腺病理学家之间的观察者间一致性较高(kappa = 0.82-0.87)。对玻片评分与配对数字图像评分的观察者内部一致性也接近完美(kappa = 0.89-0.98)。在10.1%的幻灯片/图像对中发现了不一致的读数,并且在大多数情况下,数字图像得分更高。在null和ultra - low病例中观察到大多数不一致。与玻片相比,数字图像的一致评分产生了更少的零分和更多的1+分。25%到48%的临床报告HER2评分为0的病例被归类为零。我们的研究表明,即使在表达谱的低端,手动HER2评分的观察者之间的高水平一致性也是可以实现的。重要的是,玻片和图像读数在很大程度上是一致的,但数字图像评分可能在低免疫组织化学染色水平下更敏感。
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来源期刊
Human pathology
Human pathology 医学-病理学
CiteScore
5.30
自引率
6.10%
发文量
206
审稿时长
21 days
期刊介绍: Human Pathology is designed to bring information of clinicopathologic significance to human disease to the laboratory and clinical physician. It presents information drawn from morphologic and clinical laboratory studies with direct relevance to the understanding of human diseases. Papers published concern morphologic and clinicopathologic observations, reviews of diseases, analyses of problems in pathology, significant collections of case material and advances in concepts or techniques of value in the analysis and diagnosis of disease. Theoretical and experimental pathology and molecular biology pertinent to human disease are included. This critical journal is well illustrated with exceptional reproductions of photomicrographs and microscopic anatomy.
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