Evaluation and comparison of radioimmunoassay methods using monoclonal or polyclonal antibodies for the assay of cyclosporine in blood samples.

Results obtained measuring blood Cyclosporine A (CsA) concentrations in transplanted patients (124 samples of cardiac, 20 samples of liver, and 10 samples of kidney transplanted patients) by the use of two monoclonal radioimmunoassay (RIA) methods have been compared with those found using the HPLC technique (considered as the reference method) and two polyclonal RIAs. In addition, results on quality control samples collected in a multicentre collaborative study for CsA assay from the users of the same monoclonal and polyclonal RIAs were analysed to evaluate the performance of the methods under study. Polyclonal RIAs, which measure both the parent molecule and its metabolites, produced results 1.5-3 times higher than HPLC or monoclonal RIAs. On the contrary the two RIAs, which use monoclonal antibodies specific for CsA, show a better correlation with HPLC; these RIAs, which measure the intact drug molecule only, are recommended when the monitoring of the native molecule of CsA is requested. As far as the reproducibility is concerned, the four RIAs (both polyclonal and monoclonal) exhibit an unsatisfactory degree of between-assay and between-lab precision, since the coefficients of variation (CVs) ranged from 19.4% to 23.1%.