Expert review of medical devices · 2025
The development of a novel device to aid in capillary macro blood self-sampling via an iterative study design.
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Herrijgers Corinne, Van Landeghem Ella, Vanroye Fien, Cuylaerts Vicky, Kenyon Chris, Vanbaelen Thibaut, Van Lent Kurt, Smekens Bart, Decuypere Saskia, Bosman Evi, De Cock Natalie, Couwenbergh Camille, Baert Ella, Wymeersch Rien, Sorgeloos Kristof, Beyers Koen, Dierickx Tim, Van den Bossche Dorien, Platteau Tom, De Baetselier Irith
Аннотация
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-blood sampling methods are scarce. The device was developed to enable standardized, user-friendly self-sampling of ≥ 500 µL capillary fingerprick blood.
RESEARCH DESIGN AND METHODS: Via an iterative, mixed-method approach, we optimized the Collect2Know device (C2K) across five 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 may have 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 Collect2Know device (C2K) across five 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 may have the potential to enhance access to diagnostics, reduce healthcare burdens, and support public health efforts in both high- and low-resource settings.