Validation of a Capillary Dry Blood Sample MITRA-Based Assay for the Quantitative Determination of Systemic Tacrolimus Concentrations in Transplant Recipients.

Abstract:

BACKGROUND:Tacrolimus is a narrow therapeutic index medication, which requires therapeutic drug monitoring to optimize dosing based on systemic exposure. MITRA microsampling offers a convenient, minimally invasive approach for the collection of capillary blood samples from a fingerprick versus conventional venous blood sampling for quantitation of tacrolimus blood concentrations. However, the suitability of MITRA microsampling for the determination of tacrolimus concentrations requires assessment in clinical settings. METHODS:Paired venous (2 mL) and capillary (10 μL) blood samples were collected pre tacrolimus dose and 1 and 3 h postdose during routine outpatient visits from stable adult liver or kidney transplant patients receiving prolonged-release tacrolimus. Tacrolimus concentrations were determined by liquid chromatography-tandem mass spectrometry, and the concentrations obtained by the two sampling methods were compared by linear regression and Bland-Altman agreement analyses. RESULTS:Samples were available for 82 transplant recipients (kidney, n=41; liver, n=41). A high correlation was observed between tacrolimus concentrations in capillary and venous blood samples (Pearson's correlation coefficient, 0.97; Lin's concordance coefficient, 0.87; slope of the fitted line, >1.0). Tacrolimus concentrations in capillary samples were 22.5% higher on average than in the corresponding venous blood samples (95% limits of agreement, 0.5% to 44.6%). Similar results were observed in both transplant subgroups. CONCLUSIONS:MITRA fingerprick sampling provides a convenient alternative to venipuncture for therapeutic drug monitoring in transplant recipients maintained on prolonged-release tacrolimus. When using the fingerprick MITRA method, the positive bias in tacrolimus concentrations observed with this technique, when compared with venipuncture, needs to be taken into consideration.

journal_name

Ther Drug Monit

authors

Undre N,Dawson I,Aluvihare V,Kamar N,Saliba F,Torpey N,Anaokar S,Kazeem G,Hussain I

doi

10.1097/FTD.0000000000000847

subject

Has Abstract

pub_date

2020-12-03 00:00:00

eissn

0163-4356

issn

1536-3694

pub_type

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