An immunohistochemical double-staining three-marker kit for breast invasive carcinoma Ki-67 index interpretation

By using a mixed primary antibody of myoepithelial and glandular epithelial markers and Ki-67 antibody for immunohistochemical multiple staining on breast cancer tissue sections, the problem of distinguishing between invasive breast cancer and carcinoma in situ was solved, and the percentage of Ki-67 positive cells was accurately interpreted, reducing subjective errors.

CN117434050BActive Publication Date: 2025-10-24FUZHOU MAIXIN BIOTECH CO LTD
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Patent Information

Application Number
CN202210817868.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-07-12
Publication Date
2025-10-24
Estimated Expiration
2042-07-12

AI Technical Summary

Technical Problem

In existing technologies, it is difficult to distinguish between invasive breast cancer and carcinoma in situ. The interpretation of the percentage of Ki-67 positive tumor cells is greatly influenced by the subjectivity of clinicians and pathologists, leading to biased results.

Method used

Using a mixed primary antibody consisting of myoepithelial marker antibody, glandular epithelial marker antibody, and Ki-67 antibody, the same breast or breast cancer tissue section was simultaneously labeled by immunohistochemical multiple staining. Combining morphological characteristics and color differences, the invasive carcinoma and carcinoma in situ, as well as the interstitial and lymphocyte regions, were accurately distinguished.

Benefits of technology

It enables accurate counting of Ki-67 positive cells in invasive cancer areas, reducing subjective errors and improving the accuracy and efficiency of interpretation.

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Abstract

The application provides an immunohistochemical double-staining three-marker kit for breast invasive carcinoma Ki-67 index interpretation, which comprises a mixed primary antibody; the mixed primary antibody comprises a mouse antibody and a rabbit antibody; the mixed primary antibody comprises a myoepithelial marker antibody, a glandular epithelial marker antibody and a Ki-67 antibody; the myoepithelial marker antibody and the glandular epithelial marker antibody are located in the cytoplasm and / or cell membrane. Different from the prior art, the above technical scheme adopts the mixed primary antibody of the myoepithelial marker antibody, the glandular epithelial marker antibody and the Ki-67 antibody, can simultaneously and synchronously mark on the same breast or breast cancer tissue section, and accurately and quickly distinguishes the invasive carcinoma and the carcinoma in situ and the interstitial and lymphocyte regions through the immunohistochemical multiplex staining mode. Combined with morphological characteristics, through the location and color difference, the invasive carcinoma region is obviously displayed, and the percentage of Ki-67 positive cells in the invasive carcinoma region is calculated.
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