Procedures and practices for the validation of bioanalytical methods using dried blood spots: a review
Jager et al.
The finding, in our words
This review of 68 dried blood spot validation reports found inconsistent validation practices and no regulatory guidelines, identifying haematocrit, spotting volume and spot inhomogeneity as critical challenges that must be standardised for reliable decentralised drug monitoring.
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.
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 ↗
The consensus guideline defining the analytical- and clinical-validation requirements for dried-blood TDM: the standardisation reference for implementing a dried assay clinically.
Capiau et al., Therapeutic Drug Monitoring (paywalled) · source ↗