Hi Sarah, Here is the 2014 AP checklist question covering your question. Note the part at the end about ER, PR, HER2 in case you are doing those. I can post that as well if it's applicable.
ANP.22750 Antibody Validation Phase II The laboratory has documented validation of new antibodies, prior to use in patient diagnosis. NOTE: The performance characteristics of each assay in the immunohistochemistry laboratory must be appropriately validated before being placed into clinical use. The initial goal is to establish the optimal antibody titration, detection system, and antigen retrieval protocol. Once optimized, a panel of tissues must be tested to determine the assay's sensitivity and specificity. The scope of the validation is at the discretion of the laboratory director and will vary with the antibody. For a well-characterized antibody with a limited spectrum of antigenic targets, like chromogranin or prostate specific antigen, the validation can be limited. A panel of 10 positive and 10 negative neoplasms would be sufficient in this setting. For an antibody that is not well characterized and/or has a wide range of reported reactivity, a more extensive validation is necessary. The number of tissues tested should, in this circumstance, be large enough to determine whether the staining profile matches that previously described. An exception to the above requirements is that studies may not be feasible for antigens such as ALK that are only seen in rare tumors. This checklist has additional validation requirements for HER2 and estrogen/progesterone receptor testing in breast carcinoma. Please refer to the subsection "Predictive Markers," below. Evidence of Compliance: ✓ Written procedure for the evaluation/validation of new antibodies Hope that helps! Bryan Szpunar, HT(ASCP) Histology Lead LabCorp Indianapolis 7750 Zionsville Road Indianapolis, IN 46268 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet