Title :

Interlaboratory analysis of isavuconazole plasma concentration assays among european laboratories

Author(s) :

Pea, Federico [Auteur]
Krause, Robert [Auteur]
Muller, Carsten [Auteur]
Hennart, Benjamin [Auteur]
Richardson, Malcolm [Auteur]
Meinitzer, Andreas [Auteur]
Wiesen, Martin H. J. [Auteur]
Wiktorowicz, Tatiana [Auteur]
Spickermann, Jochen [Auteur]
Henriksen, Anne S. [Auteur]

Journal title :

Therapeutic drug monitoring

Abbreviated title :

Ther Drug Monit

Volume number :

41

Pages :

657-664

Publication date :

2019-10-01

ISSN :

1536-3694

Keyword(s) :

LC-UV
LC-FL
LC-MS/MS
isavuconazole
bioassay

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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. 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 chromatography-tandem 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. Twenty-seven laboratories participated in the study (LC-MS/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 (LC-MS/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). Alignment of methodologies among laboratories may be warranted to improve the accuracy and reproducibility of therapeutic drug measurements.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Institut Pasteur de Lille
Université de Lille

Collections :

• IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483

Submission date :

2022-02-02T10:24:23Z