title: Conversion of cardiac and liver transplant recipients from HPLC and FPIA (polyclonal) to an FPIA (monoclonal) technique for measurement of blood cyclosporin A.
abstract: In an effort to replace HPLC and FPIA (polyclonal) for whole blood determination of Cyclosporin A (CsA), this study examined the application of FPIA (monoclonal) in patients post cardiac and liver transplantation. The assay had a minimum detectable dose of 15 microg/L, an overall recovery of 97% and was linear to 1200 microg/L, and gave inter-assay precision values of < 5% (CV). On comparing FPIA (monoclonal) and HPLC for 59 cardiac transplant recipient blood samples, a correlation of FPIA (monoclonal) = 1.30 (HPLC) + 36.34, r = 0.96 was obtained. With liver transplant samples (n = 348), the correlation was FPIA (monoclonal) = 1.21 (HPLC) + 42.15, r = 0.98. Correlation on 131 cardiac transplant recipients gave FPIA (monoclonal) = 0.31 FPIA (polyclonal) + 43.97, r = 0.68. It is concluded that when converting from HPLC to FPIA (monoclonal) a positive bias of 21%-30% is observed, and in replacing FPIA (polyclonal) with FPIA (monoclonal), a negative bias of 50%-69% is seen with liver and cardiac patients respectively. These data indicate that therapeutic ranges should be re-established or adjustments in CsA dosing would be necessary.
authors.affiliation: Department of Pathology and Laboratory Medicine, UCLA School of Medicine, Los Angeles, California 90095-1732, USA. jmcbride@pathology.medsch.ucla.edu
authors.forename: J H
authors.initials: JH
authors.lastname: McBride
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: D O
authors.initials: DO
authors.lastname: Rodgerson
authors.forename: A
authors.initials: A
authors.lastname: Reyes
mesh_terms: D000911:Antibodies, Monoclonal; D002851:Chromatography, High Pressure Liquid; D016572:Cyclosporine / Q000097:blood*; D016903:Drug Monitoring / Q000379:methods; D016231:Fluorescence Polarization Immunoassay / Q000379:methods*; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood; D016031:Liver Transplantation; D012016:Reference Values; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D016572:Cyclosporine