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Hormone Receptor Studies (Estrogen and Progesterone) by Immunohistochemistry (IHC)

ER/PR, ER, ERPR, Estrogen Receptor, Progesterone Receptor

Department

Advanced Diagnostics

Specimen Collection Criteria

Collect (preferred specimen): Formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue should be well fixed and well processed.

• Per ASCO-CAP guidelines, specimen must have cold ischemia time less than 1 hour; and fixed for a minimum of 6 hours and a maximum of 72 hours in 10% neutral buffered formalin  

Also acceptable: One H&E slide plus 5 unstained tissue sections cut at 4 um thick and placed on charged slides. Air dry, do not oven dry. Tissue adherence cannot be guaranteed for sections placed on plain glass slides. Send all slides within 6 weeks of cutting. 

All specimens must be accompanied by a completed requisition containing the patient name, date of birth, collection date, ordering physician, source of specimen, fixation time and cold ischemia time (if known), and a pathology report.

Physician Office/Draw Specimen Preparation

Maintain paraffin-embedded tissue or slides at room temperature (20-25°C or 68-77°F) until transport. 

Preparation for Courier Transport

Transport: Paraffin-embedded tissue, at room temperature (20-26°C or 68-78.8°F). 

Rejection Criteria

• Tissue in fixatives other than 10% formalin or zinc formalin.
• Improper labeling, inadequate information.

Inpatient Specimen Preparation

Please refer to Surgical Specimen, Routine in the Beaumont Laboratory Test Directory. 

In-Lab Processing

Maintain specimens at room temperature (20-26°C or 68-78.8°F) until testing. 

Storage

Specimen Stability for Testing:

Paraffin-Embedded Tissue 
Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable 
Frozen (-20°C/-4°F or below): Unacceptable 

Tissue Section on Glass Slides
Room Temperature (20-26°C or 68-78.8°F): 6 weeks
Refrigerated (2-8°C or 36-46°F): Unacceptable 
Frozen (-20°C/-4°F or below): Unacceptable 

Specimen Storage in Department Prior to Disposal: 

Room Temperature (20-26°C or 68-78.8°F): 7 days 

Laboratory

Dearborn Anatomic Pathology – Histology E225 

Royal Oak Anatomic Pathology – Advanced Diagnostics Laboratory.

Performed

Dearborn
Daily. Results available in 2-3 business days 

Royal Oak
Daily. Results available in 7 business days. 

Reference Range

Negative: ≤0.4% reactive cells. 
Positive: ≥ 1% reactive cells. 

Test Methodology

Dearborn
Immunoperoxidase staining and detection of hormone receptors (ER and PR) is performed on formalin-fixed, paraffin-embedded tissue sections using multimer based detection system. 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and then sequentially incubated with Rabbit Monoclonal Primary Antibody (ER clone SP1, PR clone IE2) and following by a multimer detection reagent. Sections are subsequently treated with the chromogen 3, 3’- diaminobenzidine and the substrate horseradish peroxidase to produce a brown nuclear precipitate in cells expressing receptors. Sections are lightly counterstained with hematoxylin II. 

Royal Oak
Immunoperoxidase staining and detection of hormone receptors (ER and PR) is performed on formalin-fixed, paraffin-embedded tissue sections using polymer-based detection system. 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and then sequentially incubated with anti-receptor monoclonal antibodies (ER clone Ep 1; PR clone PgR 636) and following by a polymer detection reagent. Sections are subsequently treated with the chromogen 3, 3’- diaminobenzidine and the substrate horseradish peroxidase to produce a brown nuclear precipitate in cells expressing receptors. Sections are lightly counterstained with hematoxylin.

Interpretation

Dearborn
Immunoperoxidase-stained slides are semi-quantitated using a Modified San Antonio Score:

• Proportionality Score (PS): “1” is 1/100; “2” is 1/10; “3” is 1/3; “4” is 2/3; and “5” is 100% of the tumor nuclei.
• Intensity Score (IS): “1” is faint; “2” is distinct; and “3” is intense.
• Total Score (TS): 0-2/8 is negative; 3/8 is equivocal; 4-8/8 is positive.

Royal Oak
Immunoperoxidase-stained slides are quantitated using digital imaging. The pathologist will provide an interpretive report. Reactivity is reported as negative (≤0.4% reactive cells) or positive (≥1% reactive cells). This is in accordance with the ASCO/CAP guidelines for testing estrogen and progesterone receptors in breast cancer.  

 

 

Clinical Utility

The test is most frequently used in breast carcinomas when decisions on hormonal therapy must be made. NOTE: Estrogen/progesterone receptor testing is not appropriate and not performed for cases of lobular carcinoma in-situ. 

Reference

1. Battifora, H, et al. Estrogen Receptor Immunohistochemical Assay in Paraffin-Embedded Tissue: A Better Gold Standard - Applied Immunohistochemistry, 1(1):39-45, 1993. 
    
2. Ogawa, Y, Moriya, T, Kato, Y, et al. Immunohistochemical Assessment for Estrogen Receptor and Progesterone Receptor Status in Breast Cancer: Analysis for a Cut-Off Point as the Predictor for Endocrine Therapy. Breast Cancer 11(3):267-275, 2004.  
3. Hammond, Elizabeth, et al. American Society of Clinical Oncology/College of American Pathologist Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer. Arch Pathol Lab Med. 2010 Jul;134 (7):e48-72.  

CPT Codes

Dearborn:
Technical: 88360 x2.
Professional: 88360x2.

Royal Oak:
Technical: 88361x2.
Professional: 88361x2.

Contacts

Last Updated

8/15/2022