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Article History

Received: 27 April 2025

Accepted: 21 November 2025

First Online: 28 November 2025

Declarations

:

: This study was approved by the Institutional Review Board (IRB) of the Korea University Guro Hospital (IRB numbers: 2021GR0229, 2021GR0317, and 2021GR0600). All participants received a thorough explanation of the study’s purpose and procedures, and any questions were fully addressed by the researchers. Written informed consent was obtained from all participants prior to participation in the usability test. They were informed of their right to withdraw from the study at any time or to decline to answer any questions without penalty or disadvantage.

: Not applicable. This manuscript does not contain any individual person’s data in any form (including images, videos, or identifiable information).

: This study was commissioned by the manufacturer of the self-testing kits as part of a contracted usability evaluation. None of the authors are employees of, or hold stock in, the company that commissioned the evaluation. The commissioning party had no role in the selection of test kits, data collection, statistical analysis, interpretation of results, or decisions regarding manuscript preparation and publication. All analyses and manuscript development were conducted independently by the authors. The raw data are available upon reasonable request. The authors declare no other competing interests. The usability evaluations described in this manuscript were initially conducted as independent, contracted assessments for the manufacturers of the respective self-testing kits, performed as part of their pre-market regulatory approval process. To ensure complete scientific independence, a contractual agreement was established prior to the commencement of each evaluation. This agreement explicitly stipulated that the commissioning manufacturers would have no role in the study design, data collection protocols, data analysis, interpretation of the results, or the decision to prepare and submit the findings for publication. The contract also granted the authors the right to use the anonymized data for independent academic research. None of the authors are employees of, or hold stock in, the commissioning companies. All analyses and the writing of this manuscript were conducted without any input or oversight from the sponsors. The authors declare no other competing interests. The usability evaluations described in this manuscript were initially conducted as independent, contracted assessments for the manufacturers of the respective self-testing kits, performed as part of their pre-market regulatory approval process. To ensure complete scientific independence, a contractual agreement was established prior to the commencement of each evaluation. This agreement explicitly stipulated that the commissioning manufacturers would have no role in the study design, data collection protocols, data analysis, interpretation of the results, or the decision to prepare and submit the findings for publication. The contract also granted the authors the right to use the anonymized data for independent academic research. None of the authors are employees of, or hold stock in, the commissioning companies. All analyses and the writing of this manuscript were conducted without any input or oversight from the sponsors. The authors declare no other competing interests.