This antibody is intended for in vitro diagnostic (IVD) use.
The CD57 (IHC539) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnoses of diseases, as an aid in the identification of T-cell large granular lymphocyte disorders, oligodendrogliomas, and neuroendocrine tumors within the context of antibody panels, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist.
Cluster of differentiation 57 (CD57), also known as NK-1, is an antigen detectable in natural killer cells, some T-lymphocytes and normal peripheral blood mononuclear cells, myeloid cells, and a variety of polypeptides, lipids, and chondroitin sulfate proteoglycans. CD57 is indicated as a marker for tumors of neuroendocrine origin, including pheochromocytomas, paragangliomas, carcinoid tumor, and medulloblastomas, as well as various neural tumors including neuromas, neurofibromas, schwannomas, and granular cell tumors. CD57 is also detectable in ganglioneuroma and prostate carcinoma. Anti-CD57 is used to distinguish nodular lymphocyte-predominant Hodgkin’s lymphoma from T-cell/histiocyte-rich large B-cell lymphoma, nodular sclerosis Hodgkin’s disease, and follicular lymphoma.