Evaluation of QMS Everolimus Assay Using Indiko Analyzer

Buthiau, Delphine; Bargnoux, Anne-Sophie; Badiou, Stéphanie; Sutra, Thibault; Dupuy, Anne‐Marie; Pageaux, Georges‐Philippe; Mourad, Georges; Cristol, Jean‐Paul

doi:10.1097/ftd.0000000000000133

Cited by 11 publications

(1 citation statement)

References 12 publications

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“…This can be understood considering the lack of agreement between various IAs despite manufacturers tracing the results to LC-MS/MS (their own reference) as well as between a single IA (QMS/EVER) and several different LC-MS/MS methods. 15,[27][28][29][30][31][32] Therefore, the importance of agreement with LC-MS/MS in evaluating the true direction of bias between IAs should be reconsidered with respect to the characteristics of the "reference" method adopted (eg, using commercially available IVD-CE-labeled or in-house gravimetrically prepared calibrators, extraction with methanol or acetonitrile). 4 Second, this study was designed as a short-term verification study.…”

Section: Discussionmentioning

confidence: 99%

Analytical Performance of the New Siemens Affinity Chrome-Mediated Immunoassay Everolimus Assay and Its Interchangeability With the Thermo Quantitative Microsphere System for Routine Therapeutic Drug Monitoring of Patients After Solid Organ Transplantation

Ialongo

Sapio

Angeloni

2023

Therapeutic Drug Monitoring

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Background: A new homogeneous affinity chrome-mediated immunoassay (ACMIA) "EVRO" from Siemens Healthcare was evaluated for therapeutic drug monitoring of everolimus (EVL) with automated sample pretreatment and compared with quantitative microsphere system (QMS) "EVER" from Thermo Fisher Scientific.Methods: Imprecision, inaccuracy, and limit of quantitation (LoQ) of ACMIA/EVRO were verified using both hemolysate quality control (QC) samples and pooled whole blood specimens. The interchangeability of methods and the agreement of results were analyzed using 72 specimens (from 38, 30, and 4 kidney, liver, and lung transplant recipients, respectively).Results: Within-run imprecision ranged within %CV = 2.81-2.53 with pooled whole blood specimens and within %CV = 2.88-2.53 with QCs; total imprecision with QCs was within %CV = 2.14-1.51. Inaccuracy with value assigned QC was %O = 5.36 at the 5.6 ng/ mL level and %O = 5.56 at the 11.7 ng/mL level. LoQ was 0.93 ng/mL (%CV = 10). Passing-Bablok regression showed a constant bias of 0.679 ng/mL (95% CI: 0.216-1.026) and a proportional bias of 1.326 (95% CI: 1.240-1.425). Bland-Altman analysis showed 5/ 72 (6.9%) paired differences exceeding the limits of agreement and 1/72 (1.4%) paired differences exceeding 1.96 SD to a combined bias of 39.9% after detrending.Conclusions: ACMIA/EVRO shows satisfactory analytical performances that comply with recommendations, but it does not fulfill requirements for interchangeability with QMS/EVER. Particularly, this new assay using sirolimus-specific antibody shows a sizable proportional bias versus the more specific comparator, which may be because of EVL metabolites. This is supported by the lack of agreement for individual differences in most samples collected at the peak concentration (C2). Therefore, further evidence is needed to support the transition of EVL level monitoring from QMS/EVER to ACMIA/EVRO without making extensive changes to both reference interval and patient's baseline.

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Section: Discussionmentioning

confidence: 99%

Analytical Performance of the New Siemens Affinity Chrome-Mediated Immunoassay Everolimus Assay and Its Interchangeability With the Thermo Quantitative Microsphere System for Routine Therapeutic Drug Monitoring of Patients After Solid Organ Transplantation

Ialongo

Sapio

Angeloni

2023

Therapeutic Drug Monitoring

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Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs

Zhang

2017

Drug Testing and Analysis

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Therapeutic drug monitoring (TDM) of immunosuppressive drugs (ISDs) with a narrow therapeutic index is an increasingly popular tool for minimizing drug toxicity while maximizing the prevention of graft loss and organ rejection. This review focuses on trends regarding analytical methods for theTDM of ISDs since 2011. The five most commonly prescribed immunosuppressive medications are critically reviewed: cyclosporine A, tacrolimus, sirolimus (rapamycin), everolimus, and mycophenolic acid. This review introduces the general background of TDM and ISDs and presents the recent developments in using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and immunoassays for the TDM of ISDs. Finally, a future perspective for these analytical methods is briefly discussed.

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Therapeutic drug monitoring of immunosuppressants by liquid chromatography–mass spectrometry

McShane

Bunch

Wang

2016

Clinica Chimica Acta

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Evaluation of QMS Everolimus Assay Using Indiko Analyzer

Abstract: The QMS everolimus method on Indiko analyzer demonstrated reliable and reproducible performances allowing routine monitoring in transplant patients.

Cited by 11 publications

References 12 publications

Analytical Performance of the New Siemens Affinity Chrome-Mediated Immunoassay Everolimus Assay and Its Interchangeability With the Thermo Quantitative Microsphere System for Routine Therapeutic Drug Monitoring of Patients After Solid Organ Transplantation

Analytical Performance of the New Siemens Affinity Chrome-Mediated Immunoassay Everolimus Assay and Its Interchangeability With the Thermo Quantitative Microsphere System for Routine Therapeutic Drug Monitoring of Patients After Solid Organ Transplantation

Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs

Therapeutic drug monitoring of immunosuppressants by liquid chromatography–mass spectrometry

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