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

Sebastiano Barco, Elio Castagnola, Iulian Gennai, Laura Barbagallo, Anna Loy, Gino Tripodi, Giuliana Cangemi

Research output: Contribution to journalArticle

Abstract

Background: Vancomycin therapeutic drug monitoring (TDM) is necessary for effective and safetherapy. The aim of the this paper was to develop a specific and robust ultra high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for vancomycin quantification starting from low plasma volumes to be applied for the routine TDM in children. Methods: Samples from children receiving intravenous vancomycin were analysed using a TSQ Quantum Access MAX Triple Quadrupole system coupled with an Accela 1250 UHPLC system after a rapid protein precipitation. Gradient separation chromatography was carried out using a Hypersil GOLD aQ C18 column (50 × 2.1 mm, particle size 1.9 μm). Method performance was validated following international guidelines. Results: UHPLC–MS/MS allowed a rapid and specific quantification of vancomycin over the range 0.1–128 μg/mL from 50 μL of plasma with high reproducibility and accuracy in the absence of matrix effect. The comparison with the commercial immunoassay performed on 138 samples demonstrated the presence of a proportional bias. The concentrations of vancomycin measured with immunoassay were found to be 4.5% (95% CI: 1.3–7.7) higher than those determined with UHPLC–MS/MS. Importantly, a clinical discordance was found in about 10% of samples analysed. Conclusions: This new UHPLC–MS/MS method is accurate and specific for the measurement of vancomycin starting from small (50 μL) plasma volumes. The use of UHPLC–MS/MS is recommended to prevent a misclassification of therapeutic or toxic vancomycin levels in paediatrics.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalJournal of Chemotherapy
DOIs
Publication statusAccepted/In press - May 29 2016

Fingerprint

Vancomycin
Tandem Mass Spectrometry
Immunoassay
High Pressure Liquid Chromatography
Plasma Volume
Drug Monitoring
Poisons
Particle Size
Chromatography
Mass Spectrometry
Guidelines
Pediatrics
Proteins

Keywords

  • Method validation
  • Therapeutic drug monitoring
  • UHPLC–MS/MS
  • Vancomycin

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Oncology
  • Pharmacology

Cite this

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title = "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",
abstract = "Background: Vancomycin therapeutic drug monitoring (TDM) is necessary for effective and safetherapy. The aim of the this paper was to develop a specific and robust ultra high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for vancomycin quantification starting from low plasma volumes to be applied for the routine TDM in children. Methods: Samples from children receiving intravenous vancomycin were analysed using a TSQ Quantum Access MAX Triple Quadrupole system coupled with an Accela 1250 UHPLC system after a rapid protein precipitation. Gradient separation chromatography was carried out using a Hypersil GOLD aQ C18 column (50 × 2.1 mm, particle size 1.9 μm). Method performance was validated following international guidelines. Results: UHPLC–MS/MS allowed a rapid and specific quantification of vancomycin over the range 0.1–128 μg/mL from 50 μL of plasma with high reproducibility and accuracy in the absence of matrix effect. The comparison with the commercial immunoassay performed on 138 samples demonstrated the presence of a proportional bias. The concentrations of vancomycin measured with immunoassay were found to be 4.5{\%} (95{\%} CI: 1.3–7.7) higher than those determined with UHPLC–MS/MS. Importantly, a clinical discordance was found in about 10{\%} of samples analysed. Conclusions: This new UHPLC–MS/MS method is accurate and specific for the measurement of vancomycin starting from small (50 μL) plasma volumes. The use of UHPLC–MS/MS is recommended to prevent a misclassification of therapeutic or toxic vancomycin levels in paediatrics.",
keywords = "Method validation, Therapeutic drug monitoring, UHPLC–MS/MS, Vancomycin",
author = "Sebastiano Barco and Elio Castagnola and Iulian Gennai and Laura Barbagallo and Anna Loy and Gino Tripodi and Giuliana Cangemi",
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T1 - 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

AU - Barco, Sebastiano

AU - Castagnola, Elio

AU - Gennai, Iulian

AU - Barbagallo, Laura

AU - Loy, Anna

AU - Tripodi, Gino

AU - Cangemi, Giuliana

PY - 2016/5/29

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N2 - Background: Vancomycin therapeutic drug monitoring (TDM) is necessary for effective and safetherapy. The aim of the this paper was to develop a specific and robust ultra high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for vancomycin quantification starting from low plasma volumes to be applied for the routine TDM in children. Methods: Samples from children receiving intravenous vancomycin were analysed using a TSQ Quantum Access MAX Triple Quadrupole system coupled with an Accela 1250 UHPLC system after a rapid protein precipitation. Gradient separation chromatography was carried out using a Hypersil GOLD aQ C18 column (50 × 2.1 mm, particle size 1.9 μm). Method performance was validated following international guidelines. Results: UHPLC–MS/MS allowed a rapid and specific quantification of vancomycin over the range 0.1–128 μg/mL from 50 μL of plasma with high reproducibility and accuracy in the absence of matrix effect. The comparison with the commercial immunoassay performed on 138 samples demonstrated the presence of a proportional bias. The concentrations of vancomycin measured with immunoassay were found to be 4.5% (95% CI: 1.3–7.7) higher than those determined with UHPLC–MS/MS. Importantly, a clinical discordance was found in about 10% of samples analysed. Conclusions: This new UHPLC–MS/MS method is accurate and specific for the measurement of vancomycin starting from small (50 μL) plasma volumes. The use of UHPLC–MS/MS is recommended to prevent a misclassification of therapeutic or toxic vancomycin levels in paediatrics.

AB - Background: Vancomycin therapeutic drug monitoring (TDM) is necessary for effective and safetherapy. The aim of the this paper was to develop a specific and robust ultra high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for vancomycin quantification starting from low plasma volumes to be applied for the routine TDM in children. Methods: Samples from children receiving intravenous vancomycin were analysed using a TSQ Quantum Access MAX Triple Quadrupole system coupled with an Accela 1250 UHPLC system after a rapid protein precipitation. Gradient separation chromatography was carried out using a Hypersil GOLD aQ C18 column (50 × 2.1 mm, particle size 1.9 μm). Method performance was validated following international guidelines. Results: UHPLC–MS/MS allowed a rapid and specific quantification of vancomycin over the range 0.1–128 μg/mL from 50 μL of plasma with high reproducibility and accuracy in the absence of matrix effect. The comparison with the commercial immunoassay performed on 138 samples demonstrated the presence of a proportional bias. The concentrations of vancomycin measured with immunoassay were found to be 4.5% (95% CI: 1.3–7.7) higher than those determined with UHPLC–MS/MS. Importantly, a clinical discordance was found in about 10% of samples analysed. Conclusions: This new UHPLC–MS/MS method is accurate and specific for the measurement of vancomycin starting from small (50 μL) plasma volumes. The use of UHPLC–MS/MS is recommended to prevent a misclassification of therapeutic or toxic vancomycin levels in paediatrics.

KW - Method validation

KW - Therapeutic drug monitoring

KW - UHPLC–MS/MS

KW - Vancomycin

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