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.
A 2025 review maps 28 microsampling devices, from dried spots and volumetric absorptive tips to upper-arm liquid capillary collectors, and names what a laboratory must control before their results are used: the haematocrit effect in non-volumetric dried samples, interstitial fluid from finger milking, volume, haemolysis and transport stability. Regulators on both sides of the Atlantic ask for the same two things, a device the patient can use safely and a sample fit for the test.
The authors observe that self-sampling devices for capillary blood are gaining traction as a patient-preferred alternative to venous collection, with one centre reporting a 15 percent reduction in laboratory test volumes when local collection was offered. They argue that successful integration into total laboratory automation requires addressing cost, transport regulations and sample volume adequacy while ensuring robust device design and seamless workflow compatibility.
Poland & Cobbaert, Clinical chemistry and laboratory medicine (paywalled) · source ↗
Microsampling reduces sample volume, invasiveness, logistics and biohazard risk while improving stability and enabling at-home self-sampling, yet clinical adoption remains slow and requires standardisation and harmonisation to realise its patient-centric and decentralised potential.
Thangavelu et al., Analytical science advances · source ↗
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
Maass et al., Clinical and Translational Science · source ↗
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.
Francke et al., Therapeutic drug monitoring · source ↗