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

Malaria Journal

Marcela Macedo¹  Eduardo Garbin¹  Dhélio Pereira²  Daniel Yilma³  Arunansu Talukdar⁴  Marcelo Brito⁵  Marcus V. G. Lacerda⁶  Santasabuj Das⁷  Emily Gerth-Guyette⁸  Abhijit Sharma⁸  Gonzalo J. Domingo⁸  Sampa Pal⁸  Stephanie Zobrist⁸  Wondimagegn Adissu⁹ 

[1] Centro de Pesquisa Em Medicina Tropical (CEPEM), Pôrto Velho, Rondônia, Brazil;Centro de Pesquisa Em Medicina Tropical (CEPEM), Pôrto Velho, Rondônia, Brazil;Universidade Federal de Rondônia (UNIR), Pôrto Velho, Rondônia, Brazil;Clinical Trial Unit, Jimma University, Jimma, Ethiopia;Department of Internal Medicine, Jimma University, Jimma, Ethiopia;Department of General Medicine, Medical College, 73, Kolkata, India;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, FMT/HVD), Manaus, Amazonas, Brazil;Universidade Do Estado Do Amazonas, Manaus, Amazonas, Brazil;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, FMT/HVD), Manaus, Amazonas, Brazil;Universidade Do Estado Do Amazonas, Manaus, Amazonas, Brazil;Instituto Leônidas & Maria Deane (ILMD), Fiocruz, Manaus, Amazonas, Brazil;National Institute of Cholera and Enteric Diseases, Indian Council of Medical Research, Kolkata, India;PATH, 2201 Westlake Avenue, Suite 200, 98121, Seattle, WA, USA;School of Medical Laboratory Sciences, Jimma University, Jimma, Ethiopia;Clinical Trial Unit, Jimma University, Jimma, Ethiopia;

关键词: G6PD deficiency;    Point-of-care diagnostics;    Usability;    User proficiency;    User training;    Label comprehension study;    Malaria diagnosis;   

DOI  :  10.1186/s12936-021-03803-1

来源: Springer

【 摘 要 】

BackgroundPoint-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.MethodsPotential 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.ResultsForty-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.ConclusionsThese 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

【 授权许可】

CC BY