Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer-Clinical Notice

Cold Ischemic Time In the HER2 Testing Guideline, it was recommended that cold ischemia time (time between removal from patient and fixation of specimen) be as short as possible. Since that time, one paper has reported the adverse consequences of prolonged cold ischemia time on HER2 as well as ER testing. Since publication of the HER2 Testing Guideline, Khoury et. al. 1 showed that HER2 FISH (fluorescence in situ hybridization) testing was particularly vulnerable, since prolonged cold ischemia time results in preferential loss of HER2 probe signals that may lead to false negative results. We therefore recommend that the cold ischemia time be kept to one hour or less as the ER and PgR IHC Testing Guideline recommendation states. The time of removal of the tissue from the patient and the time the tissue went in fixative must be documented either on the accession slip or in the report or in both.

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