A Scoring Method for Immunohistochemical Staining on Ki67

Appl Immunohistochem Mol Morphol. 2021 Mar 1;29(3):e20-e28. doi: 10.1097/PAI.0000000000000853.

Abstract

An accurate interpretation of immunohistochemistry (IHC) staining results is crucial for precise disease diagnosis. In this study, we present a novel scoring method for interpreting and reporting of IHC staining assay results for the nuclear-type molecule. On the basis of the histologic characteristics, the samples were subdivided into 3 basic structural units and tissue subtypes including covered, mosaic, and mesenchymal subtypes. A cut-off of moderate-positive (2+) cells and 10% as the differential expression were applied to stratify the results into 11 grade scoring system (0 to X level). The observer can directly identify and count the number and percentage of positive cells from IHC staining data. Furthermore, Ki67 staining results in 88 carcinoma specimens were re-evaluated to determine the ease, reliability, reproducibility, and variance among different observers. The results indicated the consistency ratio of 68.0% for the mosaic subtype and 80% for the mesenchymal subtype, and 68.2% for the covered subtype by 5 experienced pathologists independently. Using 10% as the cut-off threshold, the consistency ratio of 92.5%, 96.8%, and 92.9% was noted for mosaic, mesenchymal, and covered subtypes, respectively. Besides, the correlation of counts revealed excellent agreement among the 5 independent pathologists. Overall, the proposed IHC scoring method is a novel, simple, reliable, and reproducible grading system for accurate interpretation of IHC staining data. Furthermore, the presented practical grading approach has the potential to improve the clinical evaluation of the IHC staining data for personalized therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Humans
  • Immunohistochemistry / methods*
  • Ki-67 Antigen / metabolism*
  • Observer Variation
  • Reproducibility of Results
  • Research Design / standards*

Substances

  • Ki-67 Antigen
  • MKI67 protein, human