2016 · J. Pharmaceutical and Biomedical Analysis · paywalled
Clinical feasibility of dried blood spots: analytics, validation, and applications
Enderle, Foerster & Burhenne
The finding, in our words
A review of clinical DBS across TDM, metabolic monitoring and trials, arguing that analytical and clinical validation must be obligatory before clinical use.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
This review outlines practical considerations for using dried blood spot microsampling in therapeutic drug monitoring, including patient selection, sampling technique, transport and laboratory analysis, to support its adoption in clinical practice and reduce the need for hospital-based venous sampling.
The consensus guideline defining the analytical- and clinical-validation requirements for dried-blood TDM: the standardisation reference for implementing a dried assay clinically.
In AML and CLL, 91% of VAMS venetoclax results fell within 20% of plasma after individualised haematocrit correction; in home sampling, 18 of 21 patients self-sampled independently and 76% of returned samples were analysable, which shows home microsampling is workable, though the authors ask for multicentre validation.
Guidance on capillary-to-plasma conversion: method- and analyte-specific clinical validation with paired capillary–venous samples before reporting plasma-equivalent results.
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.