Universität zu Köln

Pea, Federico, Krause, Robert, Mueller, Carsten, Hennart, Benjamin, Richardson, Malcolm, Meinitzer, Andreas, Wiesen, Martin H. J., Wiktorowicz, Tatiana, Spickermann, Jochen and Henriksen, Anne S. (2019). Interlaboratory Analysis of Isavuconazole Plasma Concentration Assays Among European Laboratories. Ther. Drug Monit., 41 (5). S. 657 - 665. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1536-3694

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Abstract

Background: Under certain circumstances, clinicians treating patients with isavuconazole for invasive aspergillosis or mucormycosis may use therapeutic drug monitoring. However, the accuracy and reproducibility of the various assays used by different laboratories for the quantification of isavuconazole plasma concentrations have yet to be determined. Methods: Human plasma samples spiked with known concentrations of isavuconazole were provided to 27 European laboratories that took part in a round-robin test (an interlaboratory test performed independently at least 2 times; 2 rounds performed in the current study). Assay methods included liquid chromatographytandem mass spectrometry (LC-MS/MS), LC with ultraviolet detection (LC-UV), LC with fluorescence detection (LC-FL), and bioassay. The accuracy and reproducibility compared with the known concentrations for each sample in each round were compared overall, between assays, and between laboratories. Results: Twenty-seven laboratories participated in the study (LCMS/MS, n = 15; LC-UV; n = 9; LC-FL, n = 1; bioassay, n = 2). In round 1, for nominal concentrations of 1000, 1700, 2500, and 4000 ng/mL, the mean (SD) determined concentrations were 1007 (183), 1710 (323), 2528 (540), and 3898 (842) ng/mL, respectively. In round 2, for nominal concentrations of 1200, 1800, 2400, and 4000 ng/mL, the mean (SD) determined concentrations were 1411 (303), 2111 (409), 2789 (511), and 4723 (798) ng/mL, respectively. Over both rounds, determined concentrations were consistently within 15% of the nominal concentrations for 10 laboratories (LCMS/MS, n = 4; LC-UV, n = 5; bioassay, n = 1) and consistently exceeded the upper 15% margin for 7 laboratories (LC-MS/MS and LC-UV, n = 3 each; LC-FL, n = 1). Conclusions: Alignment of methodologies among laboratories may be warranted to improve the accuracy and reproducibility of therapeutic drug measurements.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pea, Federico UNSPECIFIED UNSPECIFIED UNSPECIFIED Krause, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Hennart, Benjamin UNSPECIFIED UNSPECIFIED UNSPECIFIED Richardson, Malcolm UNSPECIFIED UNSPECIFIED UNSPECIFIED Meinitzer, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiesen, Martin H. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiktorowicz, Tatiana UNSPECIFIED UNSPECIFIED UNSPECIFIED Spickermann, Jochen UNSPECIFIED UNSPECIFIED UNSPECIFIED Henriksen, Anne S. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-131610
DOI:	10.1097/FTD.0000000000000632
Journal or Publication Title:	Ther. Drug Monit.
Volume:	41
Number:	5
Page Range:	S. 657 - 665
Date:	2019
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1536-3694
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PERFORMANCE LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRY METHOD; AZOLES; ASPERGILLOSIS; QUANTITATION; VORICONAZOLE; SAFETY Multiple languages Medical Laboratory Technology; Pharmacology & Pharmacy; Toxicology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/13161