2023 · Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · paywalled
New perspectives for the therapeutic drug monitoring of tacrolimus: Quantification in volumetric DBS based on an automated extraction and LC-MS/MS analysis
Rosé et al.
The finding, in our words
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.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
In matched clinical samples from rheumatoid arthritis, VAMS and DBS showed strong agreement for methotrexate polyglutamates (slopes 0.95-1.07; bias within -4.21% to 0.36%; SRCC ≥ 0.969), with up to 100% of total MTXPG results within ±20% limits; capillary microsampling agreed closely with whole blood but differed from red blood cells, indicating matrix-specific differences that must be accounted for when interpreting against RBC-based reference values.
The HematoCARD cartridge autonomously collects duplicate 10 microlitre dried blood spot samples from a single finger prick and shows good analytical performance for monitoring adalimumab, with accuracy between 91 and 111 per cent, linearity R squared 0.99 and coefficient of variation at or above 0.94 compared with serum reference and commercial DBS microsampling methods.
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.
VAMS microsampling found no significant difference from venous blood for tacrolimus in paediatric patients; samples were stable for 14 days, with average difference between paired at-home samples of 0.12 ± 0.94 ng/mL.