Validation of a immunoassay for the determination of vancomycin in cerebospinal fluid
DOI:
https://doi.org/10.31053/1853.0605.v76.n2.23550Keywords:
vancomycin, cerebrospinal fluid, immunoassay, drug monitoringAbstract
Introduction: Vancomycin (VAN) is an antibiotic used to treat serious infections. Its use is related to adverse effects such as acute facial hyperemia, nephrotoxicity and ototoxicity. By having a very narrow therapeutic range, its monitoring is necessary to maximize efficiency and minimize toxic effects. It is estimated that its concentration in CSF is approximately 10% of the plasma level in patients who receive intravenous treatment and who have meninges inflammation. Plasma concentrations of VAN are not a reliable indicator of those present in CSF. The aim of this study was to validate an immunological method based on the kinetic interaction of microparticles in solution (KIMS) for the determination of VAN in CSF. Materials and Methods: KIMS was validated for the evaluation of VAN in CSF. For this, the parameters of linearity, precision, accuracy, limit of detection, limit of quantification, interference, selectivity and specificity were determined. Results: The method was linear in a range between 0 and 15 µg/mL, the CV% obtained oscillated between 0.7 and 2.5% on the linear range. The LOD and LOQ were 0.4 µg/mL and 1.4 µg/mL respectively. The equation of the line obtained based on the correlation of methods between KIMS and HPLC-UV was y = 0.9151x + 1.1695, R² = 0.9453. Conclusion: The KIMS method demonstrated to have an adequate sensitivity and specificity to determine VAN in CSF and being a useful tool for monitoring patients who present complicated infections at CNS level.
Downloads
References
Brunton L.; Chabner B.; Knollman B.; Goodman E Gilman. Las Bases Farmacológicas de la Terapéutica. 11 edición, Mc Graw Hill, 2007.
Lenka J.; Lenka K. K.; Dagmar S.; Petr S.; Milan K. Modern methods for vancomycin determination in biological fluids by methods based on high-performance liquid chromatography – A review. J. Sep. Sci. 2016, 39, 6–20.
Muppidi K.; Pumerantz A.S.; Betageri G.; Wang J. Development and Validation of a Rapid High-Performance Liquid Chromatography Method with UV Detection for the Determination of Vancomycin in Mouse Plasma. J Chromat Separation Techniq. 2013, 4:1, 165.
Matsumoto K.; Takesue Y.; Ohmagari N.; Mochizuki T.; Mikamo H.; Seki M.; et al. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013, 19, 365-380.
Jill B. Thompson J.B.; Einhaus S.; Buckingham S.; Phelps S.J. Vancomycin for Treating Cerebrospinal Fluid Shunt Infections in Pediatric Patients: Review Article. J Pediatr Pharmacol Ther 2005, 10:1, 14-25.
Al Jeraisy M.; Phelps S.j.; Christensen M.L.; Einhaus S. Intraventricular Vancomycin in Pediatric Patients With CSF Shunt Infections.J.Pediatr Pharmacol Ther. 2004; 9:1, 36-42.
Jill B. Thompson J.B.; Einhaus S.; Buckingham S.; Phelps S.J. Vancomycin for Treating Cerebrospinal Fluid Shunt Infections in Pediatric Patients: Review Article. J Pediatr Pharmacol Ther 2005, 10:1, 14-25.
Shokouhi S.; Alavi Darazam I. Determination of vancomycin trough level in serum and cerebrospinal fluid of patients with acute community-acquired meningitis: A prospective study, J Infect. 2014.
Mark S. L.; Hatton J. Vancomycin administration into the cerebrospinal fluid: a review. Ann Pharmacother. 1993, 27, 912-21.
Muppidi K.; Pumerantz A.S.; Betageri G.; Wang J. Development and Validation of a Rapid High-Performance Liquid Chromatography Method with UV Detection for the Determination of Vancomycin in Mouse Plasma. J Chromat Separation Techniq. 2013, 4:1, 165.
MC-OAA: Manual de la Calidad del OAA: vigente
International Union of Pure and Applied Chemistry (IUPAC). Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis – IUPAC Technical Report – Pure & Appl.Chem. 2002, 74:5, 835-855.
International Union of Pure and Applied Chemistry (IUPAC). Nomenclature in Evaluation of Analytical Methods including detection and quantification capabilities- IUPAC recommendations– Pure & Appl.Chem. 1995, 67:10, 1699-1723.
Roche. ONLINE TDM Vancomycin Gen.3. 2017, 1-5.
Beach J.E.; Perrott J.; Turgeon R.D.; Ensom M.H.H. Penetration of Vancomycin into the Cerebrospinal Fluid: A Systematic Review. Clin Pharmacokinet. 2017. doi.10.1007/s40262-017-0548-y
Men P.; Li H.B.; Zhai S.D.; Zhao R.S. Association between the AUC0-24/MIC Ratio of Vancomycin and Its Clinical Effectiveness: A Systematic Review and Meta-Analysis. PLoS ONE 2016, 11 (1).
Mader M.M.D.; Czorlich P.; König C.; Fuhrmann V.; Kluge S.; Westphal M.; Grensemann J. Intrathecal penetration of meropenem and vancomycin administered by continuous infusion in patients suffering from ventriculitis - a retrospective analysis. Acta Neurochir. 2018, 160:11, 2099-2105.
Matsumoto K.; Takesue Y.; Ohmagari N.; Mochizuki T.; Mikamo H.; Seki M.; et al. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013, 19, 365-380.
Al Jeraisy M.; Phelps S.j.; Christensen M.L.; Einhaus S. Intraventricular Vancomycin in Pediatric Patients With CSF Shunt Infections.J.Pediatr Pharmacol Ther. 2004; 9:1, 36-42.
Lee SA, Kim JK, Jo DS, Kim SJ. Response of Vancomycin according to Steroid Dosage in Pediatric Patients with Culture-Proven Bacterial Meningitis. Infect Chemother. 2017, 49:4, 262-267.
Beach J.E.; Perrott J.; Turgeon R.D.; Ensom M.H.H. Penetration of Vancomycin into the Cerebrospinal Fluid: A Systematic Review. Clin Pharmacokinet. 2017. doi.10.1007/s40262-017-0548-y
Usman M.; Hempel G. Development and validation of an HPLC method for the determination of vancomycin in human plasma and its comparison with an immunoassay (PETINIA). SpringerPlus. 2016, 5:124.
Tariq A.; Siddiqui M.R.; Kumar J.; Reddy D.; Singh Negi P.; Chaudhary M.; et al. Development and validation of high performance liquid chromatographic method for the simultaneous determination of ceftriaxone and vancomycin inpharmaceutical formulations and biological simples. ScienceAsia. 2010, 36, 297–304.
Barco S.; Castagnola E.; Gennai I.; Barbagallo L.; Loy A.; Tripodi G.; Cangemi G. Ultra high performance liquid chromatography tandem mass spectrometry vs. commercial immunoassay for determination of vancomycin plasma concentration in children. Possible implications for everyday clinical practice, Journal of Chemotherapy. 2016, 28:5, 395-402.
Shokouhi S.; Alavi Darazam I. Determination of vancomycin trough level in serum and cerebrospinal fluid of patients with acute community-acquired meningitis: A prospective study, J Infect. 2014.
Additional Files
Published
How to Cite
Issue
Section
License
The Faculty of Medical Sciences Journal (RFCM) subscribes to the Open Access policy and does not charge authors fees for publishing, nor does it charge readers fees for accessing published articles (APC).
