Abstract
Background Therapeutic drug monitoring of mycophenolic acid (MPA) is required to optimize the immunosuppressive effect and minimize toxicity. We validated a new particle-enhanced turbidimetric inhibition immunoassay (PETINIA) for the determination of MPA levels and evaluated the relationship of MPA trough level with drug-related adverse events. Methods PETENIA and liquid chromatography-mass spectrometry (LC-MS) were used to determine MPA concentrations from 54 kidney transplant recipients (KTRs). Agreement between PETINIA and LC-MS results was assessed by Passing-Bablok regression and the Bland-Altman plot method. The association of adverse events with MPA trough level obtained by PETINIA was analyzed. Results PETINIA revealed a good agreement with the LC-MS; Regression analysis gave an equation of y¼1.27x_0.12 (r2¼0.975, p<0.001). PETINIA showed a systemic positive bias with a mean difference of 0.66mg/L compared to LC-MS. However, the magnitude of the positive bias decreased to 0.44mg/L within the therapeutic range of MPA. Multiple logistic regression showed that MPA trough level determined by PETINIA was an independent risk factor for adverse events (odds ratio 2.28, 95% CI 1.25–4.16, p¼0.007). MPA trough level predicted adverse events with a sensitivity of 77.8% and a specificity of 86.7% using a cut-off level of 5.25mg/L. Conclusions Good correlation between the two methods indicates that PETINIA is an acceptable method for the monitoring of MPA therapeutic levels. Furthermore, MPA trough level obtained by PETINIA is a useful monitoring tool to minimize toxicity in KTRs.
Original language | English |
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Pages (from-to) | 296-303 |
Number of pages | 8 |
Journal | Scandinavian Journal of Clinical and Laboratory Investigation |
Volume | 76 |
Issue number | 4 |
DOIs | |
State | Published - 14 Mar 2016 |
Keywords
- Adverse event
- Kidney transplantation
- LC-MS
- Mycophenolate
- PETINIA
- Validation