Optimal algorithm for ER/PR testing | |
Recommendation | Comments |
Positive for ER or PR if finding of ≥1% of tumor cell nuclei are immunoreactive. | These definitions depend on laboratory documentation of the following:
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Negative for ER or PR if finding of <1% of tumors cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PR (positive intrinsic controls are seen). | |
Optimal testing conditions | |
Recommendation | Comments |
Large, preferably multiple core biopsies of tumor are preferred for testing if they are representative of the tumor (grade and type) at resection. | Specimen should be rejected and repeated on a separate sample if any of the following conditions exist:
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Specimen may also be rejected and repeated on another sample if:
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Interpretation follows guideline recommendation. |
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Interpreters have method to maintain consistency and competency documented regularly. | |
Accession slip and report must include guideline-detailed elements. | |
Optimal tissue handling requirements | |
Recommendation | |
Time from tissue acquisition to fixation should be as short as possible. Samples for ER and PR testing are fixed in 10% neutral buffered fomalin (NBF) for 6 to 72 hours. Samples should be sliced at 5 mm intervals after appropriate gross inspection and margins designation and placed in sufficient volume of NBF to allow adequate tissue penetration. If tumor comes from remote location, it should be bisected through the tumor on removal and sent to the laboratory immersed in a sufficient volume of NBF. Cold ischemia time, fixative type, and time the sample was placed in NBF must be recorded. | |
Storage of slides for more than six weeks prior to analysis is not recommended. | |
Time tissue is removed from patient, time tissue is placed in fixative, duration of fixation and fixative type must be recorded and noted on accession slip or in report. |
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