Abstract
Ki-67 labeling index is essential for predicting the prognosis of breast cancer and diagnosing neuroendocrine and gastrointestinal stromal tumors. However, the current manual counting or digital image analysis (DIA) based methods are limited in terms of accurate estimation. The objective of this study was to assess and compare the capabilities of different DIA systems for Ki-67 with conventional manual counting method.A total of 239 tissue microarray cores from patients with stomach cancer were immunohistochemically stained for Ki-67 and digitally scanned. For analysis we employed three different annotation methods: whole TMA core, box selection of the epithelium, and hand-free selection of the epithelium. We used DIA system of 3DHistech, Roche, aetherAI, and manual counting by pathologists. The annotation methods showed different Ki-67 positivity but lower than the pathologist manual counting. The results demonstrate that Roche system is the preferred method for analyzing the entire TMA, whereas aetherAI excels in box selection method. Furthermore, 3DHistech is the most accurate method in terms of hands-free selection of the epithelium. Manual counting results showed good agreement among pathologists, with an average intraclass correlation coefficient of 0.93. These results emphasize the importance of carefully selecting annotation methods for determining Ki-67 positivity. In conclusion to determine the most suitable method for individual laboratories, multiple approaches should be assessed before implementing DIA system in routine practice.
Published Version
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