대한신장학회

논문분류	춘계학술대회 초록집
제목	Analytic Validation of PETINIA Assay for Therapeutic Drug Monitoring of Mycophenolic Acid in Kidney Transplant Recipients Compared with Liquid Chromatography-mass Spectrometry
저자	Jang-Hee Cho, Su Hee Kim, Ji Yeon Ham, Young-Jae Park, Min Young Seo, Sukyung Lee, Jong-Hak Lee, Sun Young Cho, Eugene Kwon, Hee-Yeon Jung, Ji-Young Choi, Sun-Hee Park, Chan-Duck Kim, Yong-Lim Kim, Kyung Eun Song
출판정보	2015; 2015(1):
키워드	Mycophenolate, Kidney transplantation, Trough level
초록	Background: Therapeutic drug monitoring of mycophenolic acid (MPA) is required to optimize immunosuppressive effect and minimized toxicity. This study validated a new particle enhanced turbidimetric inhibition immunoassay (PETINIA) assay for determination of MPA and evaluated relationship of MPA trough level with drug-related adverse events. Methods: A total of 54 kidney transplant recipients (KTRs) determined MPA concentrations prior to administration of the morning MPA using PETENIA and liquid chromatography-mass spectrometry (LC-MS) assay. Agreement betweenPETINIA and LC-MS assay was assessed by the Passing-Bablock regression and Bland-Altman plot method. Adverse events were collected from all KTRs who maintained the dosage of MPA for at least 6 month after the measurement. The association of adverse events with MPA trough level obtained by PETINIA assay was analyzed. Results: PETINIA assay revealed a good degree of agreement with LC-MS method: Regression analysis gave an equation of y=1.273×-0.119 (r=0.996, p<0.001). PETINIA assay showed a systemic positive bias with a mean difference of 0.66 μg/mL (95% confidence interval [CI] 0.47-0.84 μg/mL) compared with LC-MS. However, the magnitude of the positive bias decreased to 0.36 μg/mL (95% CI 0.29-0.44 μg/mL) within the therapeutic range of MPA. Multiple logistic regression showed that MPA trough level determined by PETINIA assay was an independent risk factor for adverse event (hazard ratio 2.28, 95% CI 1.25-4.16, p=0.007). MPA trough level predicted adverse events with a sensitivity of 77.8% and a specificity of 86.7% using a cutoff level of 5.25μg/mL. Conclusions: Positive bias of PETINIA over LC-MS assay was observed when measuring MPA concentration. However, correlation between two methods warrant that PETINIA assay is an acceptable method for the monitoring of the therapeutic MPA level. Furthermore, MPA trough level obtained by PETINIA is a useful monitoring tool to minimize toxicity in KTRs.
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