Evaluation of two sirolimus assays using the ARCHITECT-i1000® CMIA or RxL® ACMIA methods in comparison with the IMx® MEIA method

Courtais, Caroline; Dupuy, Anne‐Marie; Bargnoux, Anne Sophie; Pageaux, Georges‐Philippe; Fégueux, Nathalie; Mourad, Georges; Cristol, Jean Paul

doi:10.1515/cclm.2010.288

Cited by 7 publications

(3 citation statements)

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“…, ranged from −25.4% to 86.7%. A negative bias has also been reported with the IMx MEIA in other studies . Although use of the IMx MEIA was phased out beginning in December 2009, consideration of bias associated with this immunoassay is important when interpreting historical clinical study results that used the IMx MEIA assay.…”

Section: Discussionmentioning

confidence: 69%

Long‐term evaluation of analytical methods used in sirolimus therapeutic drug monitoring

Holt

Mandelbrot

Tortorici

et al. 2014

Clinical Transplantation

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Results of therapeutic monitoring of sirolimus blood concentrations are assay and laboratory dependent. This study compared performance over time of the IMx microparticle enzyme immunoassay (MEIA), Architect chemiluminescent microparticle immunoassay (CMIA), and liquid chromatography with mass spectrometric detection (LC/MS/MS) as part of a proficiency testing scheme. Pooled samples from sirolimus-treated patients and whole-blood samples spiked with known quantities of sirolimus were assayed monthly between 2004 and 2012. When results of pooled patient samples were compared with LC/MS/MS, the MEIA assay showed an overall mean percent bias of -2.3% ± 11.2% that, although initially positive, became increasingly negative from 2007 through 2009. The CMIA, which replaced the MEIA assay, had a mean percent bias of 21.9% ± 12.3%, remaining stable from 2007 through 2012. Similarly, for spiked samples, the MEIA showed an increasingly negative bias over time vs. LC/MS/MS, whereas CMIA maintained a stable positive bias. Based on comparison of immunoassay measurements on individual patient samples, CMIA values were more than 25% higher than MEIA values. These results highlight the importance of continued proficiency testing and regular monitoring of sirolimus assay performance. Clinicians must be aware of the methodology used and adjust target levels accordingly to avoid potential effects on efficacy and toxicity.

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Section: Discussionmentioning

confidence: 69%

Long‐term evaluation of analytical methods used in sirolimus therapeutic drug monitoring

Holt

Mandelbrot

Tortorici

et al. 2014

Clinical Transplantation

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“…There was no significant difference between mean values obtained with QMS everolimus (5.2 6 3.1 ng/ mL) or UPLC/MS/MS (5.3 6 3.1 ng/mL) method (P = 0.08). Therefore, to correct this overestimation, calibration curves should be artificially modified by the manufacturer 13 with production of calibrators that have a true value different from the assigned value. The following Passing-Bablok regression equations were obtained: QMS everolimus = 0.99 UPLC/MS/MS 2 0.15 (r = 0.95) and QMS everolimus = 0.81 Innofluor 2 0.09 (r = 0.94).…”

Section: Resultsmentioning

confidence: 99%

Evaluation of QMS Everolimus Assay Using Indiko Analyzer

Buthiau

Bargnoux

Badiou

et al. 2015

Therapeutic Drug Monitoring

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“…Sirolimus levels in whole blood were determined using a chemiluminescent microparticle immunoassay (CMIA) (Courtais et al , ) according to the manufacturer's instructions, with an Architect i1000 analyzer (Abbott Laboratories, Abbott Park, IL, USA).…”

Section: Methods and Volunteersmentioning

confidence: 99%