Abstract
Objectives: This study evaluated two immunoassays, the CEDIA® assay and the MEIA® assay, used for the measurement of whole blood levels of sirolimus in organ transplant recipients. Design and methods: We report on the performance characteristics (total precision, limit of quantitation (functional sensitivity), limit of detection (analytical sensitivity), linearity, accuracy) for each assay. Patient correlation studies were performed, and the results were analyzed using Bland–Altman plots and Passing–Bablok analysis. Results: Total precision for the MEIA assay, corresponding to three mean concentrations of 5.0, 10.6 and 20.2 ng/mL, was 10.5, 8.5, and 6.7%, respectively. The limit of detection was determined to be 1.1 ng/mL and the limit of quantitation was 1.5 ng/mL. The mean recovery for CEDIA was 105.4%, and analysis of proficiency material demonstrated a large negative bias with respect to the mass spectrometry peer mean—later determined to be due to matrix interference. Results for the CEDIA assay showed a total precision, corresponding to a mean concentration of 5.4, 10.5 and 20.7 ng/mL, of 13.5, 5.6, and 4.1%, respectively. The limit of detection was found to be 4.8 ng/mL, with a limit of quantitation of 5.2 ng/mL. The mean recovery for MEIA was 110.1%, and analysis of proficiency material demonstrated good agreement with the mass spectrometry peer mean with a slight positive bias. Both assays were acceptably linear over the reportable range of the assay. Patient correlation studies demonstrated a positive average bias for both assays versus results from LC-MS measurement (0.9 ng/mL for MEIA, 2.1 ng/mL for CEDIA). Conclusion: Based on this evaluation, the MEIA demonstrated acceptable performance for use in clinical monitoring of sirolimus. However, based on a higher limit of quantitation that falls within the therapeutic interval, the CEDIA is not recommended for clinical monitoring of sirolimus.
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