Clinical validation of the analysis of fluconazole in oral fluid in hospitalized children.

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Clinical validation of the analysis of fluconazole in oral fluid in hospitalized children.

Antimicrob Agents Chemother. 2014 Sep 2;

Authors: van der Elst KC, van Alst M, Lub-de Hooge MN, van Hateren K, Kosterink JG, Alffenaar JW, Schölvinck EH

Abstract
Fluconazole is a first-line antifungal agent for the treatment and prophylaxis of invasive candidiasis in pediatric patients. Pediatric patients are at risk of suboptimal drug exposure, due to developmental changes in gastrointestinal and renal function, metabolic capacity and volume of distribution. Therapeutic drug monitoring (TDM) can therefore be useful to prevent under-exposure of fluconazole in children and infants. Children, however, do often fear needles and can have difficult vascular access. The purpose of this study was to develop and clinically validate a method of analysis to determine fluconazole in oral fluid in pediatric patients. Twenty-one paired serum and oral fluid samples were obtained from 19 patients and were analyzed using a validated LC-MS/MS method, after cross-validation between serum and oral fluid. Results for accuracy and precision were within accepted ranges and samples were stable at room temperature for at least 17 days. A Pearson's correlation test for the fluconazole concentration in serum and oral fluid showed a correlation coefficient of 0.960 (P < 0.01). The mean oral fluid to serum concentration ratio was 0.99 (95% CI, 0.88 to 1.10) with Bland-Altman analysis. In conclusion, an oral fluid method of analysis was successfully developed and clinically validated for fluconazole in pediatric patients and can be a noninvasive, painless alternative to perform TDM of fluconazole when blood sampling is not possible or desirable. When patients receive prolonged courses of antifungal treatment and use fluconazole at home, this method of analysis can extend the possibilities of TDM for patients at home.

PMID: 25182638 [PubMed - as supplied by publisher]