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  • Title: Clinical utility of a new enzymatic assay for determination of mycophenolic acid in comparison with an optimized LC-MS/MS method.
    Author: van Gelder T, Domke I, Engelmayer J, de Fijter H, Kuypers D, Budde K, Koeger R, Luthe H, Oellerich M.
    Journal: Ther Drug Monit; 2009 Apr; 31(2):218-23. PubMed ID: 19214147.
    Abstract:
    The goal of this study was to investigate the clinical utility of a new enzymatic assay for use on COBAS INTEGRA systems (Roche Total MPA assay). From 134 patients, plasma mycophenolic acid (MPA) concentrations were measured with both the enzymatic method and a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) procedure, to compare these assays. The test principle of the enzymatic assay is inhibition of inosine monophosphate dehydrogenase. Method comparison studies revealed good agreement of results (r > 0.99), overall and in patients with delayed graft function or hypoalbuminemia. MPA area under the concentration-time curve (AUCs) obtained with LC-MS/MS (x) and the enzymatic method (y) compared excellent in patients on cyclosporine (y = 1.04x - 1.05, r = 0.992) or tacrolimus (y = 1.02x - 0.63, r = 0.987). MPA exposure determined with either method at different time points after transplantation agreed well (eg, 25th/50th/75th percentile of day 10 AUCs-LC-MS/MS: 25.8/33.8/45.2 versus enzymatic assay: 26.2/34.4/45.3 mg.h/L). AUCs calculated for both methods were lower at the first 3 time points in patients on cyclosporine compared with tacrolimus (week 4 median cyclosporine/tacrolimus: LC-MS/MS 39.6/56.4 versus enzymatic assay 40.5/56.0 mg.h/L). Both LC-MS/MS and the enzymatic methods revealed a tendency toward lower AUCs and predose levels in patients with biopsy-proven acute rejection (BPAR) (day 10 median: 0.9 mg/L with BPAR and 1.7 mg/L without BPAR). The Roche Total MPA assay is a reliable alternative to LC-MS/MS. It can be applied in the clinical setting allowing for easy, fast, and optimized patient management.
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