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Interlaboratory Analysis of Isavuconazole Plasma Concentration Assays Among European Laboratories

Federico Pea1, Robert Krause2, Carsten Müller3

  • 1Department of Medicine, University of Udine, and Institute of Clinical Pharmacology, Santa Maria della Misericordia University Hospital, ASUIUD, Udine, Italy.

Therapeutic Drug Monitoring
|October 1, 2019
PubMed
Abstract

Insights

This study evaluated isavuconazole plasma concentration assays across 27 labs. Results show significant variability, indicating a need for standardized methods to ensure accurate therapeutic drug monitoring for fungal infections.

Area of Science:

  • Clinical Chemistry
  • Pharmacology
  • Mycology

Background:

  • Clinicians may monitor isavuconazole levels for invasive aspergillosis and mucormycosis.
  • The accuracy and reproducibility of laboratory assays for isavuconazole plasma concentrations are not well-established.

Purpose of the Study:

  • To assess the accuracy and reproducibility of isavuconazole plasma concentration quantification across multiple European laboratories.
  • To compare different assay methods, including LC-MS/MS, LC-UV, LC-FL, and bioassay.

Main Methods:

  • A round-robin study involving 27 European laboratories was conducted.
  • Human plasma samples with known isavuconazole concentrations were analyzed in two independent rounds.
  • Assay methods used were liquid chromatography-tandem mass spectrometry (LC-MS/MS), LC with ultraviolet detection (LC-UV), LC with fluorescence detection (LC-FL), and bioassay.

Main Results:

  • Determined concentrations generally aligned with nominal values, but with significant inter-laboratory and inter-assay variability.
  • Ten laboratories consistently reported concentrations within 15% of nominal values.
  • Seven laboratories consistently exceeded the upper 15% margin, highlighting potential accuracy issues.

Conclusions:

  • There is a need to align methodologies among laboratories to improve the accuracy and reproducibility of isavuconazole therapeutic drug measurements.
  • Standardization is crucial for reliable therapeutic drug monitoring in patients treated with isavuconazole.

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