Feasibility, acceptability and safety of a device for self-collecting capillary blood in clinical trials
Dasari et al.
The finding, in our words
In at-home and trial settings, a wet capillary device reliably collected a median ~450 µL with a 4.4% failure rate; 88% of adults preferred self-collection over venipuncture, with lower pain.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
Adolescents collecting blood microsamples at home achieved varying success rates across six devices, with Minicollect tubes performing poorest. The confirmation that visual inspection alone was insufficient, by analytical variability, underscores the need for robust quality assessment before deploying any device in decentralised trials.
Two home-use capillary blood collection kits for HbA1c measurement produced results within 5% of venous values for 96% to 99% of samples across different shipping conditions. The kits were easy to use and yielded comparable results to venous specimens for both paediatric and adult participants, supporting their use in decentralised clinical research and care.
Dried VAMS and DBS samples collected at home and analysed after a median of three days showed poor agreement with standard venous or capillary blood for HbA1c monitoring. In contrast, wet VAMS samples analysed immediately demonstrated excellent agreement, indicating that sample drying and delayed analysis compromise reliability for decentralised HbA1c measurement.
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
In a cohort of 62 participants evaluating home self-collection with the TassoPlus device, 38 returned samples, with 29% excluded due to insufficient plasma volume below 200 ΔL. Although viral load measurements in adequate samples correlated well with conventional testing (r = 0.800), the high failure rate and missed detection in low-volume viremic samples indicate that further technical refinements are necessary before clinical adoption.