Background: Current practice requires regular venous blood samples for monitoring of tacrolimus concentrations post renal transplant requiring regular hospital visits. Mitra devices use volumetric absorptive microsampling technology and absorb a fixed amount of blood (10 μL) from a capillary blood sample. They are a viable volumetric alternative to dried blood spots and are able to be posted to the laboratory for analysis.
Objective: The aim was to develop and validate liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays for tacrolimus and creatinine analysis using Mitra devices. The usefulness of this approach was assessed in renal transplant patients routinely monitored for tacrolimus and creatinine.
Method: Routine tacrolimus samples were used to assess the utility and reliability of Mitra sampling. Shared sample preparation for both tacrolimus and creatinine was carried out in a 96-deep well plate; mass spectrometric analysis was then undertaken for tacrolimus followed by re-injection for creatinine analysis.
Results: Comparison of 131 Mitra samples with a routine LC-MS/MS assay for tacrolimus showed a minimal bias -5.6% (95% CI -8.5 to -2.7%). Comparison of 135 serum and Mitra samples for creatinine using a fully validated LC-MS/MS assay showed a bias -6.5% (95% CI -8.5 to -4.5%).
Discussion: We have developed assays for tacrolimus and creatinine on fingerprick blood using the Mitra device and believe this approach provides a viable alternative to repeated venepuncture for therapeutic drug monitoring. This method could open up the opportunity for patients to perform tacrolimus and kidney function monitoring at home.
Keywords: Mass spectrometry; evaluation of new methods; toxicology.