2025 · Expert review of medical devices · paywalled
The development of a novel device to aid in capillary macro blood self-sampling via an iterative study design
Herrijgers et al.
The finding, in our words
This study describes the iterative development of a novel capillary self-sampling device, demonstrating that the fourth prototype enabled 77.5% of users to successfully collect at least 500 µL of blood with high usability and acceptability scores.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
At-home volumetric absorptive microsampling (VAMS) for anti-seizure medicines was feasible and reliable, with strong correlations to clinic VAMS and low bias for lacosamide, lamotrigine and levetiracetam; quantitative dried blood spot (qDBS) was a reliable alternative in the ambulatory setting, though older age reduced sampling quality.
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.
This proof-of-concept study demonstrated that patients with inflammatory bowel disease could successfully perform capillary blood microsampling at home with high analytical success rates, and a majority preferred this decentralised approach over hospital venous draws.
The study found that quantitative dried blood spot sampling provided high clinical agreement for tacrolimus and creatinine monitoring, with patients rating the self-collection devices as user-friendly. These results support the feasibility of decentralised therapeutic drug monitoring for immunosuppressants.
Volumetric microsampling can enable patient-centred therapeutic drug monitoring with high patient preference and acceptable method validation for many drugs, but conversion from capillary to plasma and agreement with venous sampling varies by analyte and requires careful validation.