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22441 Estrogen/Progesterone Receptor (Paraffin), Semi-Quantitative Immunohistochemistry

Estrogen/Progesterone Receptor (Paraffin), Semi-Quantitative Immunohistochemistry
Test Code: HMISC
Synonyms/Keywords
​Histology, ER, PR, ERA, PRA, Surgical Pathology, Receptor, IHC, Immunohistochemistry, Estrogen, Progesterone
Test Components
​Estrogen IHC, Progesterone IHC
Useful For
​Most frequently used in breast carcinomas when decisions on hormonal therapy must be made. Infrequently used for non-breast cancer specimens.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Paraffin-Embedded Tissue Block or Unstained Slide​s ​ Transport Container for Block and/or Slide Holders​ ​If unstained slides are sent, 5 are required. ​ ​
​Completed Pathology Report​​​​​
Collection Processing Instructions
​
Paraffin-embedded Tissue Block Specimens:
1. Ischemic Time - removal to initiation of fixation must be less than or equal to one hour. (Breast Cancer Requirement)
2. Fixative type - 10% Neutral Buffered Formalin. (All Specimens)
3. Fixative duration requirement is 6 - 72 hours. (Breast Cancer Requirement)
Information regarding the above handling and fixative times must be documented on the accession slip and/or report according to College of American Pathologist (CAP)/American Society of Clinical Oncology (ASCO) guidelines. Estrogen and Progesterone have been validated on non-decaled, paraffin-embedded tissues, handled according to the above guidelines. Delayed, under or over fixation may affect test results.
 
Handling of Surgical Breast Specimens Obtained Remotely -
Due to regulations, the following is required when breast cancer is suspected/known:
Breast Lumpectomy
    Pat the specimen dry
    Ink the margin (see below)
    Dry again and place in vinegar (helps the ink stick)
    Make an incision in the specimen as close as possible to the lesion. Do not cut all the way through the specimen -    keep intact. More than one incision can be made on larger specimens. Cut opposite the margin closest to the  
    tumor.
Inking: Unoriented specimens are inked one color. Oriented specimen are inked six colors. You can ink however you want, but write on the requisition slip/histology order how you have inked it.
One suggestion for inking:
Superior - Blue
Inferior - Green
Medial - Red
Lateral - Orange
Anterior/Superficial - Yellow
Posterior/Deep - Black
 
Remember the specimen needs to be inked before it is incised in order to maintain integrity of the margin. Inking after the margin has been cut is not recommended. Specimen should be immersed in a sufficient volume of 10% neutral buffered formalin (10X volume of specimen). Contact Histology Pathology Assistants for more information.
 
REQUIREMENTS:
Completed histology requisition form or Authorization for Test Requests form #9-25034.
Surgical or cytology pathology report containing pertinent patient history, tissue source, and diagnosis.
One paraffin tissue/cell block with corresponding H&E slide, otherwise send 4 (3-4 micron) unstained, air-dried, charged slides with corresponding H&E slide. See Collection Processing Instructions. 
 
 
Antibody validations were performed on 10% neutral buffered, formalin-fixed, paraffin embedded tissues/cell blocks.
Acceptable Specimen Types
​Paraffin-embedded, Formalin Fixed Tissue Blocks, H&E Slide, and/or Unstained Air-Dried, Charged Slides
Specimen Stability Information
Specimen Type Temperature Time
Paraffin Tissue / Cell Block, Fixed in 10% NBF​ ​Room Temperature/Ambient ​Indefinite
​Unstained, Air-Dried, Charged Slides ​Room Temperature/Ambient Ideally slides should be < or = to ​6 weeks old
Rejection Criteria
Fixatives other than 10% NBF
​Decalcified Tissue (if necessary, will require a disclaimer)
​Unstained Slides (No Charge on Slides)
​Diagnosis of Lobular Carcinoma In Situ
​Insufficient Data (Incomplete Requisition/Pathology Report) - May delay testing
Interference
​Proper fixation conditions are critical for quality performance of Estrogen and Progesterone receptor staining. Under or over fixation, or delay to fixative can affect quality results. These tests are not validated on fixatives other than 10% neutral buffered formalin.
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday ​ Polymer Based Detection/Bond III​
Test Information

​Test is available with or without interpretation.

Interpretation: Semi-Quantitative Immunohistochemistry, Manual

All blocks and slides will be returned to the requestor.
 
The presence or absence of Estrogen and Progesterone receptors serve as prognostic and predictive markers for the management of breast cancer.
Reference Range Information
Performing Location Reference Range
​Marshfield Interpretative Report - Semi-Quantitative/IHC​
Interpretation

Estrogen and Progesterone Receptor Scoring System and Criteria

-Progesterone Positive- Nuclear staining of 1% or more of the tumor cells

-Estrogen Positive- Nuclear staining greater than 10% tumor cells

-Estrogen Low Positive- Nuclear staining 1-10% of tumor cells with any staining

-Negative- Nuclear staining of less than 1% of tumor cells

-Indeterminate- Specimen is considered indeterminate as result of type of fixative used (non-10% neutral buffered formalin), time to fixation (>1 hr), duration of fixation (<6 hr or >72 hr), strong decalcification, or inappropriate staining of normal internal or external assay control. Alternative samples for retesting is recommended.

 

Note: Tumor is evaluated in the context of internal and external control reactivity and of pre-analytical and analytical variables.

 

-Percent of positive-staining tumor cell nuclei is determined by estimation and reported as either 1-10%, 11-50% or >50%.

-Staining Intensity- Weak, moderate, or strong staining intensity is based on an estimate of the average staining intensity of positively stained tumor cells over the entire tumor present in the tissue section relative to positive and internal (benign glands) controls.

 

For Estrogen Receptor Low Positive Results- The cancer in this sample has a low level (1-10%) of Estrogen Receptor expression by IHC. There are limited data on the overall benefit of endocrine therapies for patients with low level (1-10%) Estrogen Receptor expression, but they currently suggest possible benefit, so patients are considered eligible for endocrine treatment. There are data that suggest invasive cancers with these results are heterogeneous in both behavior and biology and often have gene expression profiles more similar to Estrogen Receptor-negative cancers.

 

Estrogen Receptor is a rabbit monoclonal, clone SP1, and Progesterone is a mouse monoclonal, clone 16. Detection system used is a polymer. Test is validated on paraffin-embedded tissue fixed in 10% Neutral Buffered Formalin, and interpretation follows the American Society for Clinical Oncology (ASCO) and College of American Pathologist (CAP) guidelines.

 

Per ASCO/CAP guidelines, Estrogen and Progesterone IHC test results are valid for non-decalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin between 6 and 72 hours. Cold ischemic time should be no more than one hour. Results from specimens fixed outside these parameters should be interpreted accordingly.

 

Reference: Allison, et al., Arch Pathol Lab Med, 144:545-563, 2020.

Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88360 ​ ​2 Estrogen and Progesterone Receptors, Semi-Quantitative, Paraffin Block, by IHC​ ​
​
Synonyms/Keywords
​Histology, ER, PR, ERA, PRA, Surgical Pathology, Receptor, IHC, Immunohistochemistry, Estrogen, Progesterone
Test Components
​Estrogen IHC, Progesterone IHC
Ordering Applications
Ordering Application Description
​Centricity ​ER/PR Immunohist
​Cerner ​Estriol, Unconjugated, Serum (81711)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Paraffin-Embedded Tissue Block or Unstained Slide​s ​ Transport Container for Block and/or Slide Holders​ ​If unstained slides are sent, 5 are required. ​ ​
​Completed Pathology Report​​​​​
Collection Processing
​
Paraffin-embedded Tissue Block Specimens:
1. Ischemic Time - removal to initiation of fixation must be less than or equal to one hour. (Breast Cancer Requirement)
2. Fixative type - 10% Neutral Buffered Formalin. (All Specimens)
3. Fixative duration requirement is 6 - 72 hours. (Breast Cancer Requirement)
Information regarding the above handling and fixative times must be documented on the accession slip and/or report according to College of American Pathologist (CAP)/American Society of Clinical Oncology (ASCO) guidelines. Estrogen and Progesterone have been validated on non-decaled, paraffin-embedded tissues, handled according to the above guidelines. Delayed, under or over fixation may affect test results.
 
Handling of Surgical Breast Specimens Obtained Remotely -
Due to regulations, the following is required when breast cancer is suspected/known:
Breast Lumpectomy
    Pat the specimen dry
    Ink the margin (see below)
    Dry again and place in vinegar (helps the ink stick)
    Make an incision in the specimen as close as possible to the lesion. Do not cut all the way through the specimen -    keep intact. More than one incision can be made on larger specimens. Cut opposite the margin closest to the  
    tumor.
Inking: Unoriented specimens are inked one color. Oriented specimen are inked six colors. You can ink however you want, but write on the requisition slip/histology order how you have inked it.
One suggestion for inking:
Superior - Blue
Inferior - Green
Medial - Red
Lateral - Orange
Anterior/Superficial - Yellow
Posterior/Deep - Black
 
Remember the specimen needs to be inked before it is incised in order to maintain integrity of the margin. Inking after the margin has been cut is not recommended. Specimen should be immersed in a sufficient volume of 10% neutral buffered formalin (10X volume of specimen). Contact Histology Pathology Assistants for more information.
 
REQUIREMENTS:
Completed histology requisition form or Authorization for Test Requests form #9-25034.
Surgical or cytology pathology report containing pertinent patient history, tissue source, and diagnosis.
One paraffin tissue/cell block with corresponding H&E slide, otherwise send 4 (3-4 micron) unstained, air-dried, charged slides with corresponding H&E slide. See Collection Processing Instructions. 
 
 
Antibody validations were performed on 10% neutral buffered, formalin-fixed, paraffin embedded tissues/cell blocks.
Acceptable Specimen Types
​Paraffin-embedded, Formalin Fixed Tissue Blocks, H&E Slide, and/or Unstained Air-Dried, Charged Slides
Specimen Stability Information
Specimen Type Temperature Time
Paraffin Tissue / Cell Block, Fixed in 10% NBF​ ​Room Temperature/Ambient ​Indefinite
​Unstained, Air-Dried, Charged Slides ​Room Temperature/Ambient Ideally slides should be < or = to ​6 weeks old
Rejection Criteria
Fixatives other than 10% NBF
​Decalcified Tissue (if necessary, will require a disclaimer)
​Unstained Slides (No Charge on Slides)
​Diagnosis of Lobular Carcinoma In Situ
​Insufficient Data (Incomplete Requisition/Pathology Report) - May delay testing
Interference
​Proper fixation conditions are critical for quality performance of Estrogen and Progesterone receptor staining. Under or over fixation, or delay to fixative can affect quality results. These tests are not validated on fixatives other than 10% neutral buffered formalin.
Useful For
​Most frequently used in breast carcinomas when decisions on hormonal therapy must be made. Infrequently used for non-breast cancer specimens.
Test Components
​Estrogen IHC, Progesterone IHC
Reference Range Information
Performing Location Reference Range
​Marshfield Interpretative Report - Semi-Quantitative/IHC​
Interpretation

Estrogen and Progesterone Receptor Scoring System and Criteria

-Progesterone Positive- Nuclear staining of 1% or more of the tumor cells

-Estrogen Positive- Nuclear staining greater than 10% tumor cells

-Estrogen Low Positive- Nuclear staining 1-10% of tumor cells with any staining

-Negative- Nuclear staining of less than 1% of tumor cells

-Indeterminate- Specimen is considered indeterminate as result of type of fixative used (non-10% neutral buffered formalin), time to fixation (>1 hr), duration of fixation (<6 hr or >72 hr), strong decalcification, or inappropriate staining of normal internal or external assay control. Alternative samples for retesting is recommended.

 

Note: Tumor is evaluated in the context of internal and external control reactivity and of pre-analytical and analytical variables.

 

-Percent of positive-staining tumor cell nuclei is determined by estimation and reported as either 1-10%, 11-50% or >50%.

-Staining Intensity- Weak, moderate, or strong staining intensity is based on an estimate of the average staining intensity of positively stained tumor cells over the entire tumor present in the tissue section relative to positive and internal (benign glands) controls.

 

For Estrogen Receptor Low Positive Results- The cancer in this sample has a low level (1-10%) of Estrogen Receptor expression by IHC. There are limited data on the overall benefit of endocrine therapies for patients with low level (1-10%) Estrogen Receptor expression, but they currently suggest possible benefit, so patients are considered eligible for endocrine treatment. There are data that suggest invasive cancers with these results are heterogeneous in both behavior and biology and often have gene expression profiles more similar to Estrogen Receptor-negative cancers.

 

Estrogen Receptor is a rabbit monoclonal, clone SP1, and Progesterone is a mouse monoclonal, clone 16. Detection system used is a polymer. Test is validated on paraffin-embedded tissue fixed in 10% Neutral Buffered Formalin, and interpretation follows the American Society for Clinical Oncology (ASCO) and College of American Pathologist (CAP) guidelines.

 

Per ASCO/CAP guidelines, Estrogen and Progesterone IHC test results are valid for non-decalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin between 6 and 72 hours. Cold ischemic time should be no more than one hour. Results from specimens fixed outside these parameters should be interpreted accordingly.

 

Reference: Allison, et al., Arch Pathol Lab Med, 144:545-563, 2020.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday ​ Polymer Based Detection/Bond III​
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88360 ​ ​2 Estrogen and Progesterone Receptors, Semi-Quantitative, Paraffin Block, by IHC​ ​
​
For most current information refer to the Marshfield Laboratory online reference manual.