2025 · Journal of pharmaceutical and biomedical analysis · paywalled
Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling
Metscher et al.
The finding, in our words
A dried blood spot LC-MS/MS method for voclosporin was analytically validated using volumetric sampling devices, demonstrating strong agreement with whole blood analysis across a 10-600 µg/L range. The method meets ICH M10 guidelines and allows remote therapeutic drug monitoring in kidney transplant recipients.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
This review surveys published LC-MS/MS methods that use dried blood microsampling for therapeutic drug monitoring of immunosuppressants in transplantation, chemotherapy and autoimmune disease, finding that volumetric dried blood samples can replace conventional venous draws for home sampling and improve patient quality of life. The authors discuss pre-analytical considerations, clinical applicability, cost-effectiveness, harmonisation gaps and patient perception, concluding that obstacles to routine clinical implementation remain despite growing methodological maturity.
A method for tacrolimus quantification from volumetric dried blood spots collected with a hemaPEN device was validated using automated LC-MS/MS extraction. The assay was linear from 1 to 100 µg/L and met all analytical and clinical validation criteria, enabling decentralised therapeutic drug monitoring of immunosuppressants through home-based capillary blood sampling.
Volumetric dried blood spot sampling showed good agreement with conventional venous sampling for tacrolimus and mycophenolic acid concentrations in renal transplant recipients, with most concentrations and abbreviated AUCs falling within ±20% of conventional measures. Dosing recommendations differed on some occasions but the clinical impact was modest, suggesting home-based microsampling could support decentralised therapeutic drug monitoring with appropriate patient training.
This review found that volumetric microsampling devices, such as Mitra, HemaPEN, HemaXis DB10, and Tasso-M20, overcome haematocrit bias, whilst Telimmune plasma separation cards enable direct plasma collection without centrifugation. These technologies support patient-centric, decentralised sampling, though the authors note that clinical validation remains limited across different drugs and patient populations.
This study validated a dried blood spot method for tacrolimus monitoring and demonstrated agreement with venous whole blood measurements in kidney transplant recipients. It also found that dried blood spot analysis of the biomarker CXCL-10 was elevated in patients experiencing rejection or infection, supporting its use for decentralised monitoring.