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Paniagua-González L, Lendoiro E, Otero-Antón E, et al. Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination. J Pharm Biomed Anal. 2021;208:114443doi: 10.1016/j.jpba.2021.114443.
Paniagua-González, L., Lendoiro, E., Otero-Antón, E., López-Rivadulla, M., de-Castro-Ríos, A., & Cruz, A. (2022). Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination. Journal of pharmaceutical and biomedical analysis, 208114443. https://doi.org/10.1016/j.jpba.2021.114443
Paniagua-González, Lucía, et al. "Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination." Journal of pharmaceutical and biomedical analysis vol. 208 (2022): 114443. doi: https://doi.org/10.1016/j.jpba.2021.114443
Paniagua-González L, Lendoiro E, Otero-Antón E, López-Rivadulla M, de-Castro-Ríos A, Cruz A. Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination. J Pharm Biomed Anal. 2022 Jan 20;208:114443. doi: 10.1016/j.jpba.2021.114443. Epub 2021 Oct 26. PMID: 34735994.
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J Pharm Biomed Anal. 2022 Jan 20;208:114443. doi: 10.1016/j.jpba.2021.114443. Epub 2021 Oct 26.

Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination.

Journal of pharmaceutical and biomedical analysis

Lucía Paniagua-González, Elena Lendoiro, Esteban Otero-Antón, Manuel López-Rivadulla, Ana de-Castro-Ríos, Angelines Cruz

Affiliations

  1. Toxicology Service, Institute of Forensic Sciences, Universidade de Santiago de Compostela, Rúa San Francisco, s/n, 15782 Santiago de Compostela, Spain.
  2. Abdominal Trasplant Unit, Universitary Clinical Hospital of Santiago de Compostela, Rúa da Choupana, s/n, 15706 Santiago de Compostela, Spain.
  3. Toxicology Service, Institute of Forensic Sciences, Universidade de Santiago de Compostela, Rúa San Francisco, s/n, 15782 Santiago de Compostela, Spain. Electronic address: [email protected].

PMID: 34735994 DOI: 10.1016/j.jpba.2021.114443

Abstract

Therapeutic drug monitoring (TDM) of immunosuppressants is essential to avoid either rejection or toxicity after solid organ transplantations. Capillary microsampling approaches are an outstanding alternative to conventional venous sampling for TDM (easy and non-invasive collection, enabling self-sampling, and cost-saving shipment, processing and storage). Volumetric absorptive microsampling (VAMS) has gained importance in the last years, as it was meant to overcome the hematocrit (Hct) related issues commonly associated to DBS analysis. Despite all the benefits, microsampling techniques performance (including a thorough clinical validation) should be set up before their implementation in clinical practice. The aim of this study was to perform a clinical validation for both tacrolimus (TAC) and mycophenolic acid (MPA) in both DBS and Mitra™ VAMS. For the clinical validations, two different requirements were set up: analytical (following EMA and FDA guidelines) and clinical (following the Royal College of Pathologists of Australasia -RCPA- recommendations) acceptance criteria. For DBS, both analytical and clinical acceptance criteria were fulfilled for TAC, with 98.7% and 95% of the paired samples within the preset limits, respectively. For MPA, the analytical criterion was met (70.6% of paired specimens), although only half of the pairs were within the clinical limits. For VAMS, the clinical validation for both TAC and MPA showed good correlations but significant lower concentrations in VAMS compared to the routine matrices. After VAMS concentrations correction, the analytical requirement was fulfilled for both analytes (71.1% for TAC, 75% for MPA), although the more restrictive criteria recommended by the RCPA were not met for any analyte (half of the samples fell within the acceptance area). In addition, no significant Hct impact on the quantification was found in any case. Also, a preliminary home-sampling trial was set up, showing promising results. Moreover, a comparison between VAMS vs. DBS analytical and clinical performances was carried out, including a home-sampling trial, sample quality results and costs. Although the analytical performance for both VAMS and DBS was similar, DBS were superior regarding clinical criteria, sampling quality and cost.

Copyright © 2021 Elsevier B.V. All rights reserved.

Keywords: Dried blood spots (DBS); Mycophenolic acid; Sampling quality; Tacrolimus; Therapeutic drug monitoring; Volumetric absorptive microsampling (VAMS)

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this pa

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