A Whole Blood Microsampling Assay for Vancomycin: Development, Validation and Application for Pediatric Clinical Study

Abstract

Background: Vancomycin is a commonly used antibiotic, which requires therapeutic drug monitoring to ensure optimal treatment. Microsampling assays are attractive tools for pediatric clinical research and therapeutic drug monitoring. Results: A LC–MS/MS method for the quantification of vancomycin in human whole blood employing volumetric absorptive microsampling (VAMS^®) devices (20 μl) was developed and validated. Vancomycin was stable in human whole blood VAMS under assay conditions. Stability for vancomycin was established for at least 160 days as dried microsamples at -78°C. Conclusion: This method is currently being utilized for the quantitation of vancomycin in whole blood VAMS for an ongoing pediatric clinical study and representative clinical data are reported.

Keywords:

• human whole blood
• LC–MS/MS
• pediatrics
• therapeutic drug monitoring
• vancomycin
• volumetric absorptive microsampling

Financial & competing interests disclosure

KJ Downes has received research support from Merck & Co. Inc. and Pfizer, Inc. unrelated to the current work, and is supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number K23HD091365 and Children's Hospital of Philadelphia. Collection of clinical samples was performed by nurses from the CHOP Center for Human Phenomic Sciences (CHPS) and supported, in part, by the Penn/CHOP Institutional Clinical and Translational Science Award Research Center through NIH/NCATS (National Center for Advancing Translational Sciences) Grant UL1TR001878. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.