Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values

Clinical Biochemistry
Raül Rigo-BonninFrancesca Canalias

Abstract

Values of mass concentration of tacrolimus in whole blood are commonly used by the clinicians for monitoring the status of a transplant patient and for checking whether the administered dose of tacrolimus is effective. So, clinical laboratories must provide results as accurately as possible. Measurement uncertainty can allow ensuring reliability of these results. The aim of this study was to estimate measurement uncertainty of whole blood mass concentration tacrolimus values obtained by UHPLC-MS/MS using two top-down approaches: the single laboratory validation approach and the proficiency testing approach. For the single laboratory validation approach, we estimated the uncertainties associated to the intermediate imprecision (using long-term internal quality control data) and the bias (utilizing a certified reference material). Next, we combined them together with the uncertainties related to the calibrators-assigned values to obtain a combined uncertainty for, finally, to calculate the expanded uncertainty. For the proficiency testing approach, the uncertainty was estimated in a similar way that the single laboratory validation approach but considering data from internal and external quality control schemes to estimate the un...Continue Reading

Citations

May 3, 2019·Therapeutic Drug Monitoring·Mercè BrunetStein Bergan
Jan 2, 2021·Forensic Science International : Synergy·Wing-Sum ChanBobbie Kwok-Keung Cheung
Mar 16, 2021·Forensic Science International : Synergy·Joyce K KluNiamh NicDaeid

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