Volumetric Microsampling of Capillary Blood Spot vs Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus and Cyclosporin A: Accuracy and Patient Satisfaction

Michael M. Mbughuni, Maria A. Stevens, Loralie J. Langman, Yogish C. Kudva, William Sanchez, Patrick G. Dean, Paul J. Jannetto

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Immunosuppressant therapeutic drug monitoring (TDM) usually requires outpatient travel to hospitals or phlebotomy sites for venous blood collection; however Mitra® Microsampling Device (MSD) sampling could allow self-collection and shipping of samples to a laboratory for analysis. This study examined the feasibility of using volumetric microsampling by MSD for TDM of tacrolimus (TaC) and cyclosporin A (CsA) in transplant patients, along with their feedback on the process. METHODS: MSD was used to collect TaC and CsA from venous (VB) or capillary (CB) blood. The MSDs were rehydrated, extracted, and analyzed using on-line solid phase extraction coupled to tandem mass spectrometry (SPE-MS/MS). We report an abbreviated method validation of the MSD including: accuracy, precision, linearity, carry-over, and stability using residual venous whole blood (VB) samples. Subsequent clinical validation compared serially collected MSD + CB against VB (200 µL) from transplant patients. RESULTS: Accuracy comparing VB vs. MSD+VB showed high clinical concordance (TaC = 89% and CsA = 98%). Inter- and intra-precision was ≤11.5 %CV for TaC and CsA. Samples were stable for up to 7 days at room temperature with an average difference of <10%. Clinical validation with MSD+CB correlated well with VB for CsA (slope = 0.95, r2 = 0.88, n = 47) and TaC (slope = 0.98, r2 = 0.82, n = 49). CB vs. VB gave concordance of 94% for CsA and 79% for TaC. A satisfaction survey showed 82% of patients preferred having the capillary collection option. CONCLUSION: Transplant patients favored having the ability to collect capillary samples at home for TaC/CsA monitoring. Our results demonstrate good concordance between MSD+CB and VB for TaC and CsA TDM, but additional studies are warranted.

Original languageEnglish (US)
Pages (from-to)516-530
Number of pages15
JournalThe journal of applied laboratory medicine
Volume5
Issue number3
DOIs
StatePublished - May 1 2020

Keywords

  • cyclosporine
  • dried blood spot
  • LC-MS/MS
  • microsampling
  • Mitra®
  • Neoteryx®
  • patient satisfaction
  • SPE-MS/MS
  • tacrolimus
  • therapeutic drug monitoring (TDM)

ASJC Scopus subject areas

  • Medicine(all)

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