Abstract
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 AC(1) statistics were used to assess the agreement between the methods. RESULTS: The AC(1) 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. CONCLUSIONS: R-Auto enables a good staining performance in a shorter time with less effort.