Effects of biobanking conditions on six antibiotic substances in human serum assessed by a novel evaluation protocol
-
Johannes Zander
, Barbara Maier
Abstract
Background: Although therapeutic drug monitoring (TDM) for antibiotics in critically ill patients is recommended by expert panels, no commercial tests are available for most antibiotics. Therefore, we previously developed a multi-analyte method for the quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum. However, limited stability data were available, and the relevant studies did not address the coefficients of variation of the methods applied, which may be important for verifying the storage dependency of the observed effects. Here we aimed to evaluate the storage effects of antibiotics by applying a novel evaluation protocol.
Methods: Serum-based test samples were aliquoted and stored at room temperature, 4 °C, −20 °C or −80 °C for up to 180 days. Using an innovative evaluation protocol (considering the coefficient of variation, p-value, and criterion of monotony of observed changes), we assessed whether relevant changes (defined as ≥15% in comparison with baseline) were storage dependent (defined as substantial changes).
Results: Storage at −80 °C for up to 180 days did not lead to substantial changes for any analyte. In contrast, storage at −20 °C induced substantial decreases after ≥7 days for piperacillin, tazobactam, cefepime and meropenem; after 90 days at −20 °C, only ≤23% of the initial concentrations were found for these parameters. No substantial changes were observed for linezolid and ciprofloxacin at any storage condition. All of the observed substantial changes were monotonic decreases.
Conclusions: We recommend a storage temperature of −80 °C for β-lactam antibiotics. The applied evaluation protocol yielded conclusive results and may be generally useful for stability studies.
Acknowledgments
This study was supported by a Mérieux Research Grant (day of acceptance: 5 February 2013) (Institut Mérieux, Lyon, France).
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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- Editorial
- Total error vs. measurement uncertainty: the match continues
- Review
- Application of fatty acid and lipid measurements in neuropsychiatry
- Mini Review
- The Janus faces of acquired angioedema: C1-inhibitor deficiency, lymphoproliferation and autoimmunity
- Opinion Papers
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- Genetics and Molecular Diagnostics
- Rapid detection of Mmalton α1-antitrypsin deficiency allele by real-time PCR and melting curves in whole blood, serum and dried blood spot samples
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