AJCC2401- CME/CMLE - Is the Automated Elecsys Tacrolimus Assay on the Roche cobas e602 Analyzer an Acceptable Replacement for a Liquid Chromatography Tandem Mass Spectrometry (LC- MS/MS)-based Assay?-Is the automated Elecsys tacrolimus assay on the Roche cobas e 602 analyzer an acceptable replacement for a liquid chromatography–tandem mass spectrometry

Is the automated Elecsys tacrolimus assay on the Roche cobas e 602 analyzer an acceptable replacement for a liquid chromatography–tandem mass spectrometry–based assay?

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Pdf Summary

The study evaluated the automated Roche Elecsys tacrolimus electrochemiluminescence immunoassay (ECLIA) for precision, linearity, interference, and stability, comparing it with liquid chromatography–tandem mass spectrometry (LC-MS/MS) for accuracy. The ECLIA assay demonstrated good precision, a measuring range of 0.75 to 30 ng/mL, and tolerance to common interferents. However, comparison with LC-MS/MS revealed a significant bias of 26% proportional bias with a 2.2 ng/mL mean bias, affecting interpretation. Postextraction stability testing showed samples stable at 4 C for up to 24 hours but only up to 30 minutes at room temperature. While the Roche assay offers automation benefits, the substantial bias observed poses challenges for clinical decision-making and patient care, suggesting implementation challenges due to sample stability constraints. These findings prompt the need for caution in adopting the Elecsys assay, highlighting the importance of understanding the analytical bias and potential impact on tacrolimus dosing adjustments. The study suggests maintaining the current workflow using LC-MS/MS for tacrolimus measurement due to the observed limitations of the Elecsys assay, despite its excellent analytical performance and automation benefits. The study underscores the complexities involved in transitioning to automated assays for tacrolimus monitoring and emphasizes the critical role of laboratories in providing accurate and reliable results for patient care.

Keywords

Roche Elecsys tacrolimus ECLIA

automated immunoassay precision

linearity evaluation

interference testing

stability assessment

comparison with LC-MS/MS

bias analysis

sample stability constraints

clinical decision-making challenges

tacrolimus dosing adjustments