ARUP's Laboratory Test Directory

Estrogen/Progesterone Receptor with Interpretation by Immunohistochemistry : 0049210
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Anatomic Pathology Test Request Form Recommended
  


Mnemonic: ERPR IP

Methodology: Immunohistochemistry
Performed: Mon-Fri
Reported: Within 4 days
Specimen Required: 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.

Remarks: Document time from tissue acquisition to fixation and fixation duration on submitting requisition or enter at time of order. Include surgical pathology report.

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.

Stability (collection to initiation of testing): 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
CPT Code(s): 88360 x2
Cross References: ER/PgR, ERA & PRA, ERPR, Steroid Receptor Assay