Multicenter Evaluation of a New Electrochemiluminescence Immunoassay for Everolimus Concentrations in Whole Blood.
Ther Drug Monit
; 40(1): 59-68, 2018 02.
Article
em En
| MEDLINE
| ID: mdl-29210975
ABSTRACT
BACKGROUND:
The precise monitoring of everolimus, an immunosuppressant drug, is vital for transplant recipients due to its narrow therapeutic range. This study evaluated the analytical performance of a new electrochemiluminescence immunoassay (ECLIA) for everolimus concentrations in whole blood.METHODS:
Accuracy, imprecision, and sensitivity studies for the Roche Elecsys everolimus ECLIA were performed at 5 European laboratories. The ECLIA was compared with liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods, as well as the Quantitative Microsphere System everolimus assay.RESULTS:
Everolimus ECLIA accuracies were within the range 100% ± 9%. Coefficients of variation (CVs) across the target range were ≤4.8% for repeatability and ≤8.4% for intermediate imprecision, whereas multisite reproducibility at lower (2.71 mcg/L) and higher everolimus concentrations (3.0-30.0 mcg/L) resulted in CVs of ≤13.7% and ≤12.4%, respectively. The CV at the assay's lower limit of quantification without considering bias was excellent, estimated as ≤9.3% at 0.5 mcg/L. The weighted Deming regression analysis, used for comparison of the results obtained by everolimus ECLIA and by LC-MS/MS methods, yielded a slope of 1.21 [95% confidence interval (CI) 1.15-1.26], intercept of 0.478 mcg/L (95% CI 0.241-0.716), and a Pearson correlation coefficient (r) of 0.91. A single-site comparison between the ECLIA and the Quantitative Microsphere System assay revealed a slope of 1.05 (95% CI 0.917-1.17), intercept of 1.03 mcg/L (95% CI 0.351-1.70), and r of 0.91.CONCLUSIONS:
Based on these results, the Roche Elecsys everolimus ECLIA can be considered suitable for routine therapeutic drug monitoring. A positive bias was observed with respect to LC-MS/MS methods, suggesting that it may be necessary to rebaseline individual patients when switching from LC-MS/MS to the ECLIA; however, this must also be considered for any change of method for everolimus measurement.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Luminescência
/
Técnicas Eletroquímicas
/
Everolimo
/
Microesferas
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Ther Drug Monit
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Bélgica