Potential for False-Positive Staining With a Rabbit Monoclonal Antibody to Progesterone Receptor (SP2)

This study focused on recent assessment results from the United Kingdom National External Quality Assessment Scheme for Immunocytochemistry and Fluorescence In-Situ Hybridisation breast hormone receptor module in which participants were asked to demonstrate progesterone receptors (PRs). The slides consisted of 3 infiltrating ductal breast carcinomas, previously classified as a high PR expresser, a moderate to low PR expresser, and a negative tumor. During this assessment, 2 commercial rabbit monoclonal antibodies, SP2 (Lab Vision/NeoMarkers, Fremont, CA), and 1E2 (Ventana, Tucson, AZ) were used by 15% of the participants. The SP2 rabbit monoclonal antibody showed false-positive and nonspecific staining on the previously established PR-tumor. This article highlights the necessity for all clinical laboratories to validate immunohistochemical methods and protocols when using newly marketed antibodies such as SP2; use composite tissue blocks with known levels of tumor expression such as a high, mid, and negative expression; and participate in internal and external quality assessment schemes, which can highlight potential technical issues in laboratory methods.