Progress towards development of immunoassays for detection of Mycobacterium leprae infection, employing 35kDa antigen: an update.

The 35 kDa antigen of Mycobacterium leprae is a membrane component that contains both B and T-cell stimulating epitopes. Monoclonal antibodies, primarily specific to M. leprae, have been developed against this antigen. Moreover, this antigen has been genetically engineered. Using recombinant 35 kDa antigen and/or a monoclonal antibody against an epitope on 35 kDa, a variety of antibody/antigen detecting tests have been described for detection of M. leprae infection. 35 kDa protein also stimulates peripheral blood mononuclear cells (PBMCs) from the majority of paucibacillary (PB) patients. Approaches using combined antibody and T cell are discussed.