For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Epithelial Antigen, Clone Ber-EP4, Ready-to-Use (Dako Autostainer/Autostainer Plus), is intended for use in immunohistochemistry together with Dako Autostainer/Autostainer Plus instruments. This antibody labels most epithelial cells and is useful in the differential diagnosis of adenocarcinoma versus malignant mesothelioma (1). The antibody may also aid in the detection of micrometastases in lymph nodes of patients with esophageal carcinoma (2) and in differentiating between basal and squamous cell carcinomas of the skin (3). The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

MCF-7 cells (human breast carcinoma cell line) (4).

Analysis of immunocomplexes between the antibody and lysate of ¹²⁵I surface-labeled MCF-7 cells in SDS-PAGE under reducing conditions shows that the antibody labels two polypeptides of 34 kDa and 39 kDa, respectively, corresponding to epithelial antigen. Under non-reducing conditions, the polypeptides appear as 39 kDa and 41 kDa, while deglycosylation reduces the size to 31 kDa, and 36 kDa.

In immunoprecipitation experiments, the Ber-EP4 antibody blocks the reaction of the HEA125 antibody with MCF-7 cell lysate and vice versa, showing that the two antibodies react with the same antigen. The two antibodies also produce identical staining results in cells and tissues (4).

Of 37 cell lines tested, the antibody homogeneously labels all (10/10) carcinoma cell lines, whereas all non-epithelial cell lines (26/27) are negative except for the erythromyeloid cell line K562 (4).

Ready-to-use monoclonal mouse antibody provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide.

Clone: Ber-EP4 (4). Isotype: IgG1, kappa.