Use of monoclonal antibodies to human breast‐tumor‐associated antigens in the diagnosis of fine‐needle aspirates of breast nodules: Results of a multicenter study

Abstract

Fine-needle aspiration (FNA) cytology is being increasingly employed in conjunction with physical examination and mammography in the pre-surgical diagnosis of breast nodules. In the present study, we have submitted to multicenter validation an immunocytochemical test which employs monoclonal antibodies (MAbs) to breast-tumor-associated antigens (BTAA) for the diagnosis of breast cancer. The results of this analysis, which has evaluated 846 FNAs, show that the immunological test has a sensitivity of 88.62%, a specificity of 97.9% and an accuracy of 92.4%. The predictive value of a positive and a negative finding were 98.4% and 85.57% respectively. Comparison between the cytological and immunocytochemical diagnosis displayed a higher sensitivity, accuracy and predictive value of a negative result with the latter method (p less than 0.01). Our findings clearly indicate that immunocytochemical methods can complement and improve the diagnostic accuracy of FNA cytology of breast nodules.

Immunocytodiagnosis of solid tumors employing panels of monoclonal antibodies

“…The expanding use of immunocytochemical methods may indeed result in a fulfillment of the above mentioned expectations (34). This would be obtained by the performance of multicenter validation (35) studies of immunocytodiagnostic protocols, which would in part be facilitated by the use of MoAbs of more restricted tumor specificity that may become available. In contrast to conventional cytopathology, the use of immune reagents is likely also to introduce "internal" and "external" quality control assessment criteria in an area of diagnosis which is hardly ever subjected to this standard control (36,37).…”