Application of a new volumetric microsampling device for quantitative bioanalysis of immunosuppression

Abstract

Background: Volumetric absorptive microsampling may reduce the blood collection burden associated with therapeutic drug monitoring of immunosuppression to prevent organ transplant rejection. This work describes the development of a laboratory and analytical technique for quantifying tacrolimus and mycophenolic acid (MPA) from the Tasso-M20™ in human whole blood using bead-based impact-assisted extraction. Results: The sampled blood volume was accurate with estimated volumes within <2% of the expected 20 μl. Recovery using impact-assisted extraction was 73–87% for MPA and 100% for tacrolimus and was hematocrit-independent for both analytes. The LC-MS/MS assay is precise and accurate within the acceptance criteria of 15%. Conclusion: The sampling and extraction procedures allowed for accurate quantification of tacrolimus and MPA. Exploration of abuse scenarios identified important education points for patients conducting home-based sample collections in the future.

Blood microsampling technologies: Innovations and applications in 2022

“… 63 Additionally, Leino et al also validated the application of TASSO‐M20 for the quantitative bioanalysis of tacrolimus and mycophenolic acid. 113 Although these studies demonstrated the feasibility of microsampling in TDM of IMS, results from a proficiency testing pilot for IMS microsampling assays when compared to whole blood methods showed great interlaboratory variation. Since the results influence clinical decision‐making, harmonization and standardization are thus necessary before microsampling techniques can be implemented in patient care.…”

“…111 Microsampling has been extensively studied for the determination of tacrolimus and mycophenolic acid, two of the most commonly prescribed IMS used to prevent organ rejection in recipients of solid organ transplants. 32,63,64,112,113 samples due to poor sample quality) and costs (7 times lower than Mitra device). 32,64 Additionally, use of non-contact Hct prediction strategies such as NIR and UV/VIS spectroscopy coupled to an automated DBS workflow was found to adequately correct for Hct effect in determining IMS concentrations.…”

“…In contrast, for the simultaneous monitoring of tacrolimus and kidney functioning using creatinine, VAMS was found to be the preferred single sampling option compared to DBS, as only 69.4% of paired samples with DBS were within ±15% as opposed to 81.6% with VAMS 63 . Additionally, Leino et al also validated the application of TASSO‐M20 for the quantitative bioanalysis of tacrolimus and mycophenolic acid 113 . Although these studies demonstrated the feasibility of microsampling in TDM of IMS, results from a proficiency testing pilot for IMS microsampling assays when compared to whole blood methods showed great interlaboratory variation.…”

“…Microsampling has been extensively studied for the determination of tacrolimus and mycophenolic acid, two of the most commonly prescribed IMS used to prevent organ rejection in recipients of solid organ transplants. 32 , 63 , 64 , 112 , 113 Studies conducted by Paniagua‐González et al and Zwart et al in liver or renal transplant patients, respectively, found that although DBS and VAMS, after a concentration correction, provided comparable results to conventional whole‐blood tacrolimus and plasma mycophenolic acid measurements, DBS performed better than VAMS in terms of clinical performance (98.7% of paired samples within ±20% difference as opposed to 71.1% of VAMS paired samples), sample quality (1 sample discarded as opposed to 9 VAMS samples due to poor sample quality) and costs (7 times lower than Mitra device). 32 , 64 Additionally, use of non‐contact Hct prediction strategies such as NIR and UV/VIS spectroscopy coupled to an automated DBS workflow was found to adequately correct for Hct effect in determining IMS concentrations.…”

Enhancing drug development and clinical studies with patient‐centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography‐mass spectrometry strategies

“…Among the commercially available PCS devices, the Mitra® device by Neoteryx and Tasso‐M20 by Tasso are most frequently utilized. These two devices with volumetric absorptive microsampler (VAMS) technology have been widely documented in the literatures by both pharmaceutical companies and academic institutions for their successful application in clinical trials, ensuring the acquisition of high‐quality data from samples collected using Mitra® 14–19 and Tasso‐M20 20–22 devices. In addition, TAP® (Touch Activated Phlebotomy) device by YourBio Health, 23 hemaPEN® by Neoteryx, 24 and Capitainer®B by Capitainer 25 have all been successfully applied in clinical trials.…”