Abstract
Background: Blood sampling is essential for infectious disease diagnosis and monitoring but often requires venipuncture, limiting accessibility. Self-sampling offers a decentralized alternative, yet current macro-bloodsampling methods are scarce. The Collect2Know (C2K) device was developed to enable standardized, user-friendly self-collection of ≥500 µL capillary fingerprick blood.
Research Design and Methods: Via an iterative mixed-method approach we optimized the C2K device across 5 prototypes (P1-P5). Usability, acceptability, and blood volume of each prototype were assessed among minimum 10 participants. A minimum threshold of 75% usability and acceptability and 60% of users collecting minimum 500 µL guided device refinement.
Results: The first prototype (P1) underperformed, leading to redesign. P2-P3 improved usability and acceptability but failed volume collection targets. P4 incorporated substantial improvements, making the prototype more intuitive, and 77.5% (31/40) achieved success in blood collection with usability and acceptability scores of 89.1% and 75.6%, respectively.
Conclusions: This study highlights the value of an iterative study-design, in the early stages of device development. The C2K device will facilitate capillary fingerprick macro-bloodsampling. By shifting routine blood sampling to decentralized settings, the C2K device has the potential to enhance access to diagnostics, reduce healthcare burdens, and support public health efforts in both high- and low-resource settings.
Research Design and Methods: Via an iterative mixed-method approach we optimized the C2K device across 5 prototypes (P1-P5). Usability, acceptability, and blood volume of each prototype were assessed among minimum 10 participants. A minimum threshold of 75% usability and acceptability and 60% of users collecting minimum 500 µL guided device refinement.
Results: The first prototype (P1) underperformed, leading to redesign. P2-P3 improved usability and acceptability but failed volume collection targets. P4 incorporated substantial improvements, making the prototype more intuitive, and 77.5% (31/40) achieved success in blood collection with usability and acceptability scores of 89.1% and 75.6%, respectively.
Conclusions: This study highlights the value of an iterative study-design, in the early stages of device development. The C2K device will facilitate capillary fingerprick macro-bloodsampling. By shifting routine blood sampling to decentralized settings, the C2K device has the potential to enhance access to diagnostics, reduce healthcare burdens, and support public health efforts in both high- and low-resource settings.
| Original language | English |
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| Publication status | Submitted - Feb-2025 |