The level of human epidermal growth factor receptor-2 (HER2) protein and gene expression in breast cancer is an essential factor in judging the prognosis of breast cancer patients. Several investigations have shown high intraobserver and interobserver variability in the evaluation of HER2 staining by visual examination. In this study, we aim to propose an artificial intelligence (AI)–assisted microscope to improve the HER2 assessment accuracy and reliability. Our AI-assisted microscope was equipped with a conventional microscope with a cell-level classification-based HER2 scoring algorithm and an augmented reality module to enable pathologists to obtain AI results in real time. We organized a three-round ring study of 50 infiltrating duct carcinoma not otherwise specified (NOS) cases without neoadjuvant treatment, and recruited 33 pathologists from 6 hospitals. In the first ring study (RS1), the pathologists read 50 HER2 whole-slide images (WSIs) through an online system. After a 2-week washout period, they read the HER2 slides using a conventional microscope in RS2. After another 2-week washout period, the pathologists used our AI microscope for assisted interpretation in RS3. The consistency and accuracy of HER2 assessment by the AI-assisted microscope were significantly improved (p < 0.001) over those obtained using a conventional microscope and online WSI. Specifically, our AI-assisted microscope improved the precision of immunohistochemistry (IHC) 3 + and 2 + scoring while ensuring the recall of fluorescent in situ hybridization (FISH)–positive results in IHC 2 + . Also, the average acceptance rate of AI for all pathologists was 0.90, demonstrating that the pathologists agreed with most AI scoring results.

乳腺癌中人表皮生长因子受体2（HER2）蛋白及基因表达水平是判断乳腺癌患者预后的重要因素。几项研究表明，通过目视检查评估 HER2 染色时，观察者内和观察者间的变异性很高。在这项研究中，我们旨在提出一种人工智能 (AI) 辅助显微镜，以提高 HER2 评估的准确性和可靠性。我们的人工智能辅助显微镜配备了传统显微镜，具有基于细胞级分类的 HER2 评分算法和增强现实模块，使病理学家能够实时获得人工智能结果。我们对 50 例未接受新辅助治疗的浸润性导管癌 (NOS) 病例组织了一项三轮环形研究，并从6家医院招募了33名病理学家。在第一个环形研究 (RS1) 中，病理学家通过在线系统读取了 50 张 HER2 全切片图像 (WSI)。经过 2 周的冲洗期后，他们在 RS2 中使用传统显微镜读取 HER2 载玻片。又过了 2 周的冲洗期后，病理学家使用我们的 AI 显微镜在 RS3 中进行辅助解释。AI辅助显微镜对HER2评估的一致性和准确性显着提高（p  < 0.001) 超过使用传统显微镜和在线 WSI 获得的那些。具体而言，我们的 AI 辅助显微镜提高了免疫组织化学 (IHC) 3 + 和 2 + 评分的精确度，同时确保召回 IHC 2 + 中荧光原位杂交 (FISH) 阳性结果。此外，所有病理学家对人工智能的平均接受率为 0.90，表明病理学家同意大多数人工智能评分结果。