1. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation
- Author
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Dhelio Batista Pereira, Stephanie Zobrist, Marcela Macedo, Eduardo Garbin, Gonzalo J. Domingo, Arunansu Talukdar, Sampa Pal, Marcelo A M Brito, Santasabuj Das, Marcus V. G. Lacerda, Wondimagegn Adissu, Abhijit Sharma, Emily Gerth-Guyette, and Daniel Yilma
- Subjects
Inservice Training ,Computer science ,Point-of-care diagnostics ,Point-of-care testing ,Usability ,RC955-962 ,030231 tropical medicine ,Applied psychology ,India ,Infectious and parasitic diseases ,RC109-216 ,Glucosephosphate Dehydrogenase ,Product Labeling ,03 medical and health sciences ,0302 clinical medicine ,Surveys and Questionnaires ,G6PD deficiency ,Arctic medicine. Tropical medicine ,parasitic diseases ,User proficiency ,Humans ,030212 general & internal medicine ,Product (category theory) ,User training ,Product design specification ,Malaria diagnosis ,End user ,business.industry ,Research ,Malaria ,Test (assessment) ,Comprehension ,Glucosephosphate Dehydrogenase Deficiency ,Infectious Diseases ,Workflow ,Point-of-Care Testing ,Label comprehension study ,Parasitology ,Clinical Competence ,Ethiopia ,business ,Brazil - Abstract
Background Point-of-care glucose-6-phosphate dehydrogenase (G6PD) testing has the potential to make the use of radical treatment for vivax malaria safer and more effective. Widespread use of G6PD tests as part of malaria case management has been limited, in part due to due concerns regarding product usability, user training, and supervision. This study seeks to assess how well end users can understand the Standard™ G6PD Test (SD Biosensor, Suwon, South Korea) workflow, result output, and label after training. This will ultimately help inform test registration and introduction. Methods Potential G6PD test users who provide malaria case management at three sites in Brazil, Ethiopia, and India were trained on the use of the SD Biosensor Standard G6PD Test and assessed based on their ability to understand the test workflow and interpret results. The assessment was done through a questionnaire, designed to assess product usability against key technical product specifications and fulfill regulatory evidence requirements. Any participant who obtained 85% or above correct responses to the questionnaire was considered to adequately comprehend how to use and interpret the test. Results Forty-five participants, including malaria microscopists, laboratory staff, nurses, and community health workers took part in the study. Seventy-eight percent of all participants in the study (35/45) obtained passing scores on the assessment with minimal training. Responses to the multiple-choice questions indicate that most participants understood well the test intended use, safety claims, and warnings. The greatest source of error regarding the test was around the correct operating temperature. Most test results were also read and interpreted correctly, with the haemoglobin measurement being a more problematic output to interpret than the G6PD measurement. Conclusions These data results show how a standardized tool can be used to assess a user’s ability to run a point-of-care diagnostic and interpret results. When applied to the SD Biosensor Standard G6PD Test, this tool demonstrates that a range of users across multiple contexts can use the test and suggests improvements to the test instructions and training that can improve product usability, increase user comprehension, and ultimately contribute to more widespread effective use of point-of-care G6PD tests. Trial registration: NCT04033640
- Published
- 2021