This invention relates to the production of polyclonal and monoclonal antibodies to specific regions of cyclosporine (CSA) and/or CSA metabolites/derivatives. The reactivity of these polyclonal and monoclonal antibodies make them particularly useful for immunoassays for therapeutic drug monitoring (TDM). These immunoassays or TDM kits may include polyclonal or monoclonal antibodies to specific sites of CSA and/or CSA metabolites. These kits may also include various combinations of polyclonal antibodies, polyclonal and monoclonal antibodies or a panel of monoclonal antibodies. Cyclosporine or CSA metabolite conjugate immunogens are prepared for the immunization of a host animal to produce antibodies directed against specific regions of the CSA or CSA metabolite molecule. By determining the specific binding region of a particular antibody, immunoassays which are capable of distinguishing between the parent molecule, active metabolites, inactive metabolites and other structurally similar immunosuppressant compounds are developed. The use of divinyl sulfone (DVS) as the linker arm molecule for forming cyclosporine and cyclosporine metabolite protein conjugate immunogens is described.

Esta invenção relaciona-se à produção do polyclonal e de antibodies monoclonal às regiões específicas do cyclosporine (CSA) e/ou do CSA metabolites/derivatives. O reactivity dos estes polyclonal e antibodies monoclonal fá-los particularmente úteis para immunoassays para a monitoração therapeutic da droga (TDM). Estes immunoassays ou os jogos de TDM podem incluir o polyclonal ou antibodies monoclonal aos locais específicos de metabolites de CSA e/ou de CSA. Estes jogos podem também incluir várias combinações de antibodies do polyclonal, polyclonal e antibodies monoclonal ou um painel de antibodies monoclonal. Os immunogens do conjugate do metabolite de Cyclosporine ou de CSA são preparados para o immunization de um animal do anfitrião para produzir os antibodies dirigidos de encontro às regiões específicas molécula do metabolite de CSA ou de CSA. Determinando a região obrigatória específica de um antibody particular, os immunoassays que são capazes de distinguir entre a molécula do pai, os metabolites ativos, os metabolites inativos e outros compostos estrutural similares do imunossupressor são desenvolvidos. O uso do sulfone divinyl (DVS) como a molécula do braço do linker para dar forma a immunogens do conjugate da proteína do cyclosporine e do metabolite do cyclosporine é descrito.