Evidence map›Paper›PMID 31568234›Full record

ArticleTherapeutic drug monitoring2019

Interlaboratory Analysis of Isavuconazole Plasma Concentration Assays Among European Laboratories.

Federico Pea, Robert Krause, Carsten Müller, Benjamin Hennart, Malcolm Richardson, Andreas Meinitzer, Martin H J Wiesen, Tatiana Wiktorowicz, Jochen Spickermann, Anne S Henriksen

Open access · hybridAbstract read
In one paragraph

Article in Therapeutic drug monitoring, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 6 countries.

Federico PeaDepartment of Medicine, University of Udine, and Institute of Clinical Pharmacology, Santa Maria della Misericordia University Hospital, ASUIUD, Udine, Italy.
Robert KrauseSection of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Carsten MüllerDepartment of Therapeutic Drug Monitoring, Center of Pharmacology, University Hospital of Cologne, Cologne, Germany.
Benjamin HennartToxicology and Genopathy Unit, CHU Lille, Lille, France.
Malcolm RichardsonMycology Reference Centre Manchester, ECMM Excellence Centre of Medical Mycology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.
Andreas MeinitzerSection of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Martin H J WiesenDepartment of Therapeutic Drug Monitoring, Center of Pharmacology, University Hospital of Cologne, Cologne, Germany.
Tatiana Wiktorowicz
Jochen Spickermann
Anne S Henriksen
Basilea Pharmaceutica (Switzerland) · CHMedical University of Graz · ATUniversity Hospital Cologne · DECentre Hospitalier Universitaire de Lille · FRManchester University NHS Foundation Trust · GBOspedale Santa Maria della Misericordia di Udine · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnder 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.

methodsHuman 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.

resultsTwenty-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).

conclusionsAlignment of methodologies among laboratories may be warranted to improve the accuracy and reproducibility of therapeutic drug measurements.

Indexed as

Biological AssayChromatography, LiquidDrug MonitoringEuropeHumansLaboratoriesNitrilesPlasmaPyridinesReproducibility of ResultsTandem Mass SpectrometryTriazolesisavuconazoleNitrilesPyridinesTriazoles

Identifiers

PMID31568234
PMCPMC6752689
OpenAlexW2913839623

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.