High-performance liquid chromatography versus immunoassay for the measurement of sirolimus: comparison of two methods.

摘要: Sirolimus is an immunosuppressive agent administered as prophylaxis of acute rejection to patients after kidney transplantation. Therapeutic drug monitoring (TDM) whole blood important part therapy. At present, two methods measuring concentrations are available: the reference method high-performance liquid chromatography (HPLC) with ultraviolet (UV) or mass spectrometry (MS) detection and a second technique IMx sirolimus assay, which enzyme immunoassay using microparticles coated anti-sirolimus antibodies (MEIA). The objective this study was compare methods. We examined group 42 receiving Blood taken during routine ambulatory visits. concentration in performed at same time by To methods, statistical analysis performed, yielding: r-value = 0.939 (r(2)); slope 1.04; intercept +0.38. mean higher than HPLC namely, 9.7 +/- 6.4 ng/mL versus 8.9 5.8 respectively. showed high sensitivity specificity, but it consuming labor intensive. MEIA burdened risk methodologic error, due its lack specificity caused cross-reactions metabolites. concluded that analytical still method; however, may be fast for use clinical practice.