Evaluation of QMS Everolimus Assay Using Indiko Analyzer: Comparison With an Ultra-performance Liquid Chromatography–Tandem Mass Spectrometry Method. Issue 2 (April 2015)

• Record Type: Journal Article
• Authors: Buthiau, Delphine; Bargnoux, Anne-Sophie; Badiou, Stéphanie; Sutra, Thibault; Dupuy, Anne-Marie; Pageaux, Georges-Philippe; Mourad, Georges; Cristol, Jean-Paul
• Is Part Of: Therapeutic drug monitoring. Volume 37:Issue 2(2015:Apr.)
• Publication Date: 2015-04
• Subjects: everolimus -- QMS immunoassay -- UPLC/MS/MS; Pharmacokinetics -- Periodicals; Patient monitoring -- Periodicals; Drugs -- Analysis -- Periodicals; Body fluids -- Analysis -- Periodicals; Drug Therapy -- Periodicals; Monitoring, Physiologic -- Periodicals; Pharmacology -- Periodicals; 615.7
• DOI: 10.1097/FTD.0000000000000133
• Languages: English
• ISSNs: 0163-4356

Abstract

Abstract : Background: A new particle-enhanced turbidimetric immunoassay, Quantitative Microsphere System (QMS) everolimus, was evaluated using an Indiko analyzer (Thermo Fisher Scientific). Methods: Analytical performances (imprecision, linearity, limit of detection, and limit of quantification) of this new immunoassay were evaluated. The method was compared with an ultra-performance liquid chromatography–tandem mass spectrometry (UPLC/MS/MS) method and with the previously available Innofluor Certican immunoassay on 120 whole-blood samples from 74 transplant recipients. Passing–Bablok regression and Bland–Altman plot were used for method comparisons. Results: Within- and between-day coefficients of variation were <10% at mean levels of 4.3, 8.2, and 15.9 ng/mL, respectively. This assay could be used at everolimus concentrations between 1.7 and 20 ng/mL. We obtained a Passing–Bablok regression of y = 0.99 × −0.15 (r = 0.95) when comparing with the UPLC/MS/MS method and of y = 0.81 × −0.09 (r = 0.94) when comparing with Innofluor assay. The mean and limits of agreement (mean ± 1.96 SD) of the difference between QMS everolimus and UPLC/MS/MS were −0.13 (from −2.0 to 1.74) ng/mL and were −1.19 (from −3.39 to 1.01) ng/mL between QMS everolimus and Innofluor. Conclusions: The QMS everolimus method on Indiko analyzer demonstrated reliable and reproducible performances allowing routine monitoring in transplant patients.