Analytical Performance of the CEDIA® Cyclosporine PLUS Whole Blood Immunoassay

Abstract

Cyclosporine A (CsA) is a potent immunosuppressive agent used in solid organ and bone marrow transplantation. Because of the narrow therapeutic range and variable pharmacokinetics, blood levels of CsA are routinely monitored. The performance of the CEDIA CsA PLUS whole blood immunoassay was evaluated on the Olympus AU400™, and results were compared to those obtained by high-performance liquid chromatography (HPLC), enzyme-multiplied immunoassay technique (EMIT), and fluorescence polarization immunoassay (FPIA). A total of 592 whole blood samples from patients receiving CsA were tested by each of the assays. CEDIA was linear from 25 to 2000 μg/L. Total imprecision ranged from 2.7% to 8.7% at CsA values between 48 and 1502 μg/L. Recovery of added CsA was within 10% of assigned values and was unaffected by bilirubin and lipemia. Metabolite cross-reactivity at 500 μg/L was 8.1% for AM1, 21.7% for AM4n, and 32.5% for AM9. Regression analysis revealed the following: HPLC = 0.93·CEDIA - 21.2 (r = 0.975), EMIT = 1.08·CEDIA - 25.2 (r = 0.982), and FPIA = 1.14·CEDIA + 13.4 (r = 0.984). CEDIA has acceptable analytical performance for routine CsA monitoring. Advantages are the absence of an extraction step and an extended measuring range. The disadvantage is the high metabolite cross-reactivity; however, results were similar to EMIT.