Test ID: 89213
Estrogen/Progesterone Receptor, Semi-Quantitative Immunohistochemistry, Manual
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
The test is most frequently used in breast carcinomas when decisions on hormonal therapy must be made.
While the test can be performed on any formalin-fixed, paraffin-embedded tissue, it is infrequently used for non-breast cancer specimens.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Immunohistochemical
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
ERA
ERPR
PR (Progesterone Receptor)
PRA
Progesterone Receptor
ERPRM
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
If being ordered for diagnostic purposes:
Order 5439 Surgical Pathology Consultation and then request the stains.
If being ordered for prognostic purposes:
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
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
Container/Tube: Surgical Pathology Packaging Kit (Supply T554)
Collection Instructions:
1. Submit paraffin-embedded carcinoma tissue.
2. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable.
3. Attach the green pathology address label included in the kit to the outside of the transport container.
Additional Information:
1. Information regarding fixative used, time to fixation and duration of fixation is required. When ordering 89213 Estrogen/Progesterone Receptor, Semi-Quantitative Immunohistochemistry, Manual, the following questions, as stated on the order form or presented electronically, must be answered:
-"Was specimen fixed in 10% neutral buffered formalin within 1 hour from surgical collection time? Yes, No or Unknown."
-"Has specimen been fixed in 10% neutral-buffered formalin for 6 to 72 hours? Yes, No, or Unknown."
2. According to the College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) 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.
3. Paraffin blocks will be returned with final report.
4. Estrogen/progesterone receptor testing is not appropriate and not performed for cases of lobular carcinoma in situ.
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Mixed | Ambient (preferred) | |
| Frozen | ||
| Refrigerated | ||
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 to 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.
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
Focal positive: 1-10% reactive cells
Positive: >10% 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), focally positive (1%-10% reactive cells), or positive (>10% reactive cells).
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).
Supportive Data
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Ogawa Y, Moriya T, Kato Y, et al: Immunohistochemical assessment for estrogen receptor and progesterone receptor status in breast cancer: analysis for a cutoff point as the predictor for endocrine therapy. Breast Cancer 2004;11(3):267-275
2. Fisher ER, Anderson S, Dean S, et al: Solving the dilemma of the immunohistochemical and other methods used for scoring estrogen receptor and progesterone receptor in patients with invasive breast carcinoma. Cancer 2005;103(1):164-173
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) is performed in formalin-fixed, paraffin-embedded tissue sections using a proprietary kit detection system. Four-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), focally positive (1%-10% reactive cells), or positive (>10% reactive cells).(Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88360 x 2
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 19689 | Accession Number | N/A |
| 19690 | Referring Pathologist/Physician | 46608-6 |
| 19691 | Ref Path/Phys Address | In Process |
| 19692 | Material: | In Process |
| 19693 | Tissue: | 31208-2 |
| 19694 | Interpretation: | In Process |
| 19695 | Comment: | 48767-8 |
| 19696 | SP Signing Pathologist: | N/A |
| 19697 | *Previous Report Follows* | N/A |
| 19698 | Addendum: | 35265-8 |
| 19699 | Addendum Comment: | 22638-1 |
| 19700 | Addendum Pathologist: | 19139-5 |
External
link
PDF
document
Excel
document
Word
document