Reference Interval:
| ERA:
| PGRA:
| Negative: less than 1% of nuclei staining
Positive: greater than or equal to 1% of nuclei staining
| Negative: less than 1% of nuclei staining
Positive: greater than or equal to 1% 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.
Refer to Statement A under Testing Information at http://www.aruplab.com.
|
| CPT Code(s): |
88360 ER; 88360 PR
|
Cross References: |
ER/PgR (Estrogen/Progesterone Receptor Assay, Paraffin), ERA & PRA (Estrogen/Progesterone Receptor Assay, Paraffin), ERPR (Estrogen/Progesterone Receptor Assay, Paraffin), Steroid Receptor Assay (Estrogen/Progesterone Receptor Assay, Paraffin) |
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