The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples
The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the analysis and review of immunohistochemically stained histologic slides.
Study Type
OBSERVATIONAL
Enrollment
3
IVD Study
IVD study of Ki67 IHC samples: Accuracy of analysis
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the Ki67 antibody at least 85%.
Time frame: 1 Day
IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of Ki67 are related to the average agreement for between runs, between days and between systems R\&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 80%.
Time frame: 1 Day
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