Background: 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. Methods: 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 AC1statistics were used to assess the agreement between the methods. Results: The AC1statistic 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. Conclusions: R-Auto enables a good staining performance in a shorter time with less effort.
背景：免疫组织化学（IHC）在确定癌症治疗方案中至关重要。我们先前开发了一种快速IHC方法，并在此基础上研发了全自动快速IHC染色仪（R-Auto）。本研究旨在评估R-Auto方案在乳腺癌标本中雌激素受体（ER）染色的临床可靠性，并评价其染色性能。方法：选取2015年1月至2020年6月期间我院收治的乳腺癌患者手术标本188例，分别采用R-Auto、传统人工IHC及商用自动染色仪进行ER染色。所有标本均采用Allred评分系统进行评分，随后比较R-Auto与传统IHC及商用自动染色仪的染色结果。采用加权kappa系数和AC1统计量评估方法间的一致性。结果：R-Auto与传统IHC比较的AC1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AC1统计量为0.9095（0.8620–0.9570），一致率为92.6%。这表明R-Auto与传统IHC及商用自动染色仪均具有高度一致性。值得注意的是，R-Auto将IHC所需时间从传统方法的209分钟缩短至121分钟。结论：R-Auto能以更短时间、更少人工实现良好的染色效果。
肿瘤(癌症)患者之家