Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- IVD study of Ki67 IHC samples: Accuracy of analysis
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.
排除标准
- •Slides that have lots of background that interfere with the analysis
结局指标
主要结局
IVD study of Ki67 IHC samples: Accuracy of analysis
时间窗: 1 Day
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%.
IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis
时间窗: 1 Day
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%.
次要结局
未报告次要终点