An immunohistochemistry (IHC) assay utilizing a progesterone receptor antibody is a laboratory technique used to detect the presence of progesterone receptors within tissue samples, typically from a biopsy, by visualizing the binding of a specific antibody to the progesterone receptor protein under a microscope, providing information about the hormone sensitivity of the cells and aiding in cancer diagnosis and treatment planning, particularly in breast cancer analysis.

It is intended to be used for the qualitative identification by light microscopy of human progesterone receptors in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using automated systems.

It is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and supplied in buffered saline with carrier protein containing preservative.

This antibody is utilized to perform a qualitative IHC assay to identify Progesterone Receptor (PR) expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination. There are two configurations of the RTU antibody:  Primary Antibody is provided in a Ready-to- Use (RTU) and a concentrated liquid format. The RTU format is supplied in buffered saline with carrier protein, containing a preservative.

The concentrated liquid format is for manual staining protocols. The concentrated liquid antibody format is a liquid tissue culture supernatant containing a preservative.

It is supplied for Prescription use only.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

Not applicable for 510k submission and IVDR CE Marking