Kudo Chiaki, Terata Kaori, Nanjo Hiroshi, Nomura Kyoko, Hiroshima Yuko, Takahashi Eriko, Yamaguchi Ayuko, Konno Hikari, Onji Masaaki, Wakamatsu Yuki, Kimura Yoshihiko, Takashima Shinogu, Wakita Akiyuki, Sato Yusuke, Minamiya Yoshihiro, Imai Kazuhiro
Department of Thoracic Surgery, Akita University Graduate School of Medicine, Akita 010-8543, Japan.
Department of Breast and Endocrine Surgery, Akita University Hospital, Akita 010-8543, Japan.
Cancers (Basel). 2025 Jan 23;17(3):363. doi: 10.3390/cancers17030363.
Immunohistochemistry (IHC) is crucial for determining cancer treatments. We previously developed a rapid IHC method and have now developed a fully automated rapid IHC stainer (R-Auto). This study aimed to evaluate the clinical reliability of the R-Auto protocol for staining estrogen receptors (ERs) in breast cancer specimens and evaluate the staining performance.
Between January 2015 and June 2020, 188 surgical specimens collected from breast cancer patients treated at our hospital were evaluated via ER staining using R-Auto, conventional manual IHC, and a commercial autostainer. The specimens were scored using Allred scores, after which the staining results were compared between R-Auto and conventional IHC or the commercial autostainer. Weighted kappa coefficients and AC statistics were used to assess the agreement between the methods.
The AC statistic for comparison between R-Auto and conventional IHC was 0.9490 (0.9139-0.9841), with a 95.7% agreement rate, and that for comparison between R-Auto and the commercial autostainer was 0.9095 (0.8620-0.9570), with a 92.6% agreement. There was, thus, substantial agreement between R-Auto and both conventional IHC and the commercial autostainer. However, R-Auto shortened the time required for IHC from 209 min with conventional IHC to 121 min.
R-Auto enables a good staining performance in a shorter time with less effort.
免疫组织化学（IHC）对于确定癌症治疗方案至关重要。我们之前开发了一种快速免疫组织化学方法，现在又开发了一种全自动快速免疫组织化学染色仪（R-Auto）。本研究旨在评估R-Auto方案对乳腺癌标本中雌激素受体（ER）进行染色的临床可靠性，并评估其染色性能。
2015年1月至2020年6月期间，对我院收治的乳腺癌患者的188份手术标本进行评估，分别采用R-Auto、传统手动免疫组织化学方法和商用自动染色仪进行ER染色。使用艾尔雷德评分对标本进行评分，然后比较R-Auto与传统免疫组织化学方法或商用自动染色仪的染色结果。采用加权kappa系数和AC统计量来评估方法之间的一致性。
R-Auto与传统免疫组织化学方法比较的AC统计量为0.9490（0.9139-0.9841），一致率为95.7%；R-Auto与商用自动染色仪比较的AC统计量为0.9095（0.8620-0.9570），一致率为92.6%。因此，R-Auto与传统免疫组织化学方法和商用自动染色仪之间均有高度一致性。然而，R-Auto将免疫组织化学所需时间从传统免疫组织化学方法的209分钟缩短至121分钟。
R-Auto能够在更短时间内以更少的工作量实现良好的染色性能。
