HematoCARD: A Volumetric Duplicate Dried Blood Spot Collection Cartridge Validated for Therapeutic Drug Monitoring
Van Hileghem et al.
The finding, in our words
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 paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 ↗
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.
Levens et al., Clinical Pharmacokinetics (paywalled) · source ↗
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.
Huhn & Scherf-Clavel, Therapeutic drug monitoring (paywalled) · source ↗
The study found a dried blood spot method for ustekinumab was linear from 3 to 12 mg/L with inter-day accuracy of 90.1 to 106%, enabling reliable capillary blood measurement for remote monitoring; the authors note the single-centre design.