Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation
Wan et al.
The finding, in our words
At-home capillary microsampling carried pharmacokinetic sampling across the Paxlovid phase II/III programme, with fewer than 3% of more than 800 samples unusable, and the resulting data supported the Emergency Use Authorization and subsequent FDA approval: remotely collected samples accepted in a registrational filing.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
This study established conversion methods for estimating plasma concentrations from whole blood VAMS samples for seven out of ten oral anticancer drugs, finding good agreement between capillary and venous samples. Patients reported a positive experience with home sampling using this microsampling technique.
Targeted proteomic evaluation of a novel finger-prick dried plasma device demonstrated strong quantitative correlation with conventional plasma (R = 0.99) and precision under 10% CV for 80% of quantified peptides across healthy donors. Quantified targets also remained stable during room temperature storage for up to 232 days, supporting its use for decentralised biomarker monitoring.
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.
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.