Estrogen/Progesterone Receptor with Interpretation by Immunohistochemistry
0049210
 
Immunohistochemistry Stain Form Recommended  (ARUP form #32978)Immunohistochemistry Stain Form Recommended (ARUP form #32978)
Ordering Recommendation
Mnemonic
ERPR IP
Methodology
Immunohistochemistry
Performed
Mon-Fri
Reported
Within 4 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
 
Collect
Tumor tissue.  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue no later than 1 hour after removal from patient. Fixative duration: 6-72 hours. If sending precut slides, do not oven bake. Transport tissue block or 5 unstained (3-5 micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800)522-2787.(Min: 4 slides).If sending precut slides, do not oven bake.  
Storage/Transport Temperature
Room temperature or refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than one hour. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Biopsies fixed for less than 6 hours and greater than 72 hours. Cytology specimens fixed in alcohol.  
Remarks
Document time from tissue acquisition to fixation and fixation duration on submitting requisition or enter at time of order. Include surgical pathology report.  
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
ERA: PGRA:
Negative: less than 1percent of nuclei staining
Positive: greater than or equal to 1percent of nuclei staining
Negative: less than 1percent of nuclei staining
Positive: greater than or equal to 1percent of nuclei staining
Interpretive Data
Tumor cell nuclei demonstrating immunoreactivity of greater than or equal to 1 percent are considered positive and correlate with a favorable response to hormone therapy and an improved prognosis. Tumor cell nuclei demonstrating immunoreactivity of less than 1 percent are considered negative.

A measurement of weak, moderate, or strong is reported based on an estimate of the average staining intensity of positively-stained tumor cells in the entire tissue section relative to positive and internal (benign glands) controls.

Staining is performed on paraffin-embedded formalin-fixed tissue, utilizing Ventana clones and detection system. Antibody clone for ER is SP1, clone for PR is 1E2 and the detection system is SA-HRP. Clone 1E2 was validated at ARUP against the 1A6 clone. Results were found to be comparable. These clones are not currently FDA-approved.

Evaluation of positive and negative controls for appropriate reactivity is also performed.

For more information refer to ASCO/CAP guidelines found at http://www.jco.org.

See Compliance Statement A: www.aruplab.com/CS
Note
CPT Code(s)
88360 x2
Components
Component Test Code*Component Chart Name
0049200Estrogen Receptor IP
0049201% of Nuclei Staining (ER)
0049205Progesterone Receptor IP
0049206% of Nuclei Staining (PR)
0049217Estrog/Progest Receptor Interpretation
2003377Estrogen Receptor Intensity
2003378Progesterone Receptor Intensity
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, contact interface support at interface.support@aruplab.com.
Cross References
  • ER and PR IHC
  • ER, PGR IHC
  • ER, PGR staining
  • ER/PgR
  • ERA & PRA
  • ERPR
  • Steroid Receptor Assay