engleski

Analytical validation of mycophenolate mofetil measurement with EMIT Dade Behring Assay.

Mycophenolate mofetil (MPA) plays an established role in the postoperative treatment of transplant patients as a novel antiproliferative immunosuppressant used in solid organ transplantation. MPA is given usually in combination with calcineurine inhibitor, with or without simultaneous steroid administration. The aim of our study was analytical validation of above mentioned test and introducing it in routine determination in the postoperative treatment of transplant patients to achieve optimal combination of immunosuppressive therapy for the best possible outcome of transplant patients. The concentration of mycophenolate was determined with Enzyme-linked multipliedimmuno-assay (EMIT), traceable to HPLC reference method. All determinations were performed on Viva-E Dade Behring analyser. Analytical validation of the assay included: imprecision, inaccuracy, linearity and measurement uncertainty in normal and pathological concentration range. Results Within series imprecision for the low and high concentration range (n=10) was: 3, 4 % and 3, 6 %, respectively. Inaccuracy for low and high concentration range was: 13, 3 % and 0, 16 %, respectively. Day-to-day imprecision in the samples mention above – commercial control samples for the low and high concentration range was: 4, 7 % and 7, 6 %, respectively. Using sample dilution we demonstrated low detection limit level of 0, 23 mol/L and linearity up to 46, 3 mol/L. The uncertainty of results for the normal and pathological concentration range was 13, 3 % and 2, 4 %, respectively. The target analytical value for imprecision ( 12 %) and inaccuracy ( 20%) were fulfilled. According to the obtained results, the MPA measurement could be introduced in the postoperative monitoring for liver and kidney transplant recipients.

Mycophenolate mofetil (MPA); calcineurine inhibitor; transplant recipients

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