Test Catalog

Test Id : ERPR

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Estrogen/Progesterone Receptor, Semi-Quantitative Immunohistochemistry, Manual

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Guiding decisions on hormonal therapy in patients with breast carcinomas

 

This test is not useful for cases of lobular carcinoma in situ.

Method Name
A short description of the method used to perform the test

Semi-Quantitative Immunohistochemistry

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ER/PR Semi Quant IHC Manual

Aliases
Lists additional common names for a test, as an aid in searching

ER (Estrogen Receptor)

ERA

ERPR

ERPRM

Estrogen Receptor

PR (Progesterone Receptor)

PRA

Progesterone Receptor

ISESTRIHC - Estrogen Receptor IHC, RST

ISPROGIHC - Progesterone Receptor IHC, RST

Breast

Specimen Type
Describes the specimen type validated for testing

Special

Ordering Guidance

This test is for prognostic purposes only.

 

For diagnostic purposes, order PATHC / Pathology Consultation and then request the stains.

 

Estrogen/progesterone receptor testing is not appropriate and not performed for cases of lobular carcinoma in situ.

Shipping Instructions

Attach the green pathology address label included in the kit to the outside of the transport container.

Necessary Information

1. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable.

2. Information regarding fixative used, time to fixation, and duration of fixation is required. The following questions, as stated on the order form or presented electronically, must be answered:

a. "Was specimen fixed in 10% neutral buffered formalin within 1 hour from surgical collection time? Yes, No, or Unknown."

b. "Has specimen been fixed in 10% neutral buffered formalin for 6 to 72 hours? Yes, No, or Unknown."

c. "Was tissue decalcified? Yes, No, or Unknown."

d. "Tumor type? Primary breast carcinoma, metastatic breast carcinoma, or non-breast tumor."

e. "Tumor classification? Invasive breast carcinoma, ductal carcinoma in situ, metastatic breast carcinoma, micro-invasive breast carcinoma, solid/intracystic papillary carcinoma, or non-breast tumor."

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MA002 Fixed in 10% NB formalin w/in 1 hr Yes
No
Unknown
MA003 Fixed in 10% NB formalin 6-72 hrs
MA004 Tumor Type Primary breast carcinoma
Metastatic breast carcinoma
NonBreast Tumor
MA005 Tumor Classification Invasive breast carcinoma
Ductal carcinoma in situ
Metastatic breast carcinoma
Micro-invasive breast carcinoma
Solid/intracystic Papillary carcinoma
NonBreast Tumor
MA044 Tissue was decalcified Yes
No
Unknown

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Pathology Packaging Kit (T554)

Specimen Type: Breast carcinoma

Preferred: A paraffin-embedded tissue block containing in-situ, invasive or metastatic breast carcinoma tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours and shipped at ambient temperature

Acceptable: 3 unstained sections, containing carcinoma, on charged slides cut at 4 microns <1 month ago and shipped at ambient temperature

Collection Instructions: Submit paraffin-embedded carcinoma tissue

 

Specimen Type: Non-breast carcinoma

Preferred: A paraffin-embedded tissue block containing carcinoma tissue that has been fixed in 10% neutral buffered formalin and shipped at ambient temperature

Acceptable: 3 unstained sections, containing carcinoma, on charged slides cut at 4 microns <1 month ago and shipped at ambient temperature

Collection Instructions: Submit paraffin-embedded carcinoma tissue

 

Additional Information:

1. According to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, estrogen/progesterone receptor protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Delay to fixation, under- or overfixation may affect these results.

2. Paraffin blocks will be returned with final report.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Oncology Test Request (T729)

-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

No specimen should be rejected.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Guiding decisions on hormonal therapy in patients with breast carcinomas

 

This test is not useful for cases of lobular carcinoma in situ.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The steroid hormone receptors, estrogen receptor (ER) and progesterone receptor (PR), are commonly used in the management of women with breast cancer. ER and PR status provide an indication of prognosis and of the potential benefit from hormonal therapy. Generally, ER/PR-positive tumors are more likely to respond to endocrine therapy and have a better prognosis, stage-for-stage, than receptor-negative tumors.

 

While the test can be performed on any formalin-fixed, paraffin-embedded tissue, it is infrequently used for non-breast cancer specimens.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative: <1% reactive cells

Positive: > or =1% reactive cells

Interpretation
Provides information to assist in interpretation of the test results

Immunoperoxidase-stained slides are examined microscopically by the consulting anatomic pathologist and interpreted as negative (<1% reactive cells), or positive. The percent of reactive cells is provided in the report.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The performance and quality of immunohistochemical (IHC) stains for formalin-fixed, paraffin-embedded tissue depends critically on proper fixation of tissue specimens. IHC staining of steroid hormone receptors is especially sensitive to fixation conditions (see Specimen Required for specific handling instructions).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hammond ME, Hayes DF, Dowsett M, et al: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010 Jun;134(6):907-22. doi: 10.1043/1543-2165-134.6.907. Erratum in: Arch Pathol Lab Med. 2010 Aug;134(8):1101

2. Allison KH, Hammond MEH, Dowsett M, et al: Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020 Apr 20;38(12):1346-1366. doi: 10.1200/JCO.19.02309

Method Description
Describes how the test is performed and provides a method-specific reference

Immunoperoxidase staining and detection of estrogen receptor (ER) and progesterone receptor (PR) are performed in formalin-fixed, paraffin-embedded tissue sections using a proprietary kit detection system. The 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval, and then sequentially incubated with antireceptor monoclonal antibodies (ER clone SP1 and PR clone 1E2) and followed by a proprietary kit detection system. The chromogen, diaminobenzidine, is subsequently applied to the section to produce a brown nuclear precipitate in cells expressing receptors. Sections are lightly counterstained with hematoxylin. Stained slides are examined microscopically by the consulting anatomic pathologist and interpreted as negative (<1% reactive cells), or positive with one of the following ranges: (1%-10% reactive cells), (11%-20% reactive cells), (21%-30% reactive cells), (31%-40% reactive cells), (41%-50% reactive cells), (51%-60% reactive cells), (61%-70% reactive cells), (71%-80% reactive cells), (81%-90% reactive cells), or (91%-100% reactive cells).(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 6 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week after results are reported. Materials made at Mayo Clinic may be retained at Mayo Clinic indefinitely.

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88360 x 2

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ERPR ER/PR Semi Quant IHC Manual 10480-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
MA002 Fixed in 10% NB formalin w/in 1 hr 8100-0
MA003 Fixed in 10% NB formalin 6-72 hrs 8100-0
MA004 Tumor type 44638-5
MA005 Tumor classification 21918-8
70965 Interpretation 50595-8
70966 Participated in the Interpretation No LOINC Needed
70967 Report electronically signed by 19139-5
70969 Material Received 81178-6
71620 Disclaimer 62364-5
71834 Case Number 80398-1
MA044 Tissue was decalcified 8100-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports