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

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

Glucose 6 Phosphate Dehydrogenase (G6PD) quantitation using biosensors at the point of first contact: a mixed method study in Cambodia

“…Specifically recalling the intermediate range of G6PD for participants (without a visible reference) seem to have affected their interpretations. Consistent with the previous studies [ 22 , 23 ], this study provides further evidence that adding the biosensor into VMWs’ routine armamentarium requires regular training, supervision, and support.…”

“…The majority of recommendations made by VMWs emerged from their day-to-day interaction with the biosensor and have relevance to improving the currently available biosensors. The recommendations for improvements emerged from operating the biosensors for more than a year in the rural communities [ 22 , 23 ]. Issues such as replacing the paper box with a plastic box, designing a buffer holder, smoothening the chip code insertion, improving battery notifications (not just when it is low) and replacing standard batteries with electricity-chargeable batteries (Table 3 ) bear high relevance to all the stakeholders.…”

“…The questionnaire assesses end user proficiency of the biosensor and fulfils data requirements from the WHO prequalification technical specification series TSS-2 for in vitro diagnostics medical devices [ 31 ]. The questionnaire was used in a recent multi-country study to assess biosensor user proficiency [ 22 ].…”

“…The biosensor has also been piloted in clinical trials, and implementation studies but the outcome on their accuracy and reliability is yet to be published. In laboratory-based studies the biosensor has been found to be reliable [21] and operationally appropriate when tested by laboratory technicians and health workers after training in laboratory facilities [22][23][24].…”

Quantitative G6PD point-of-care test can be used reliably on cord blood to identify male and female newborns at increased risk of neonatal hyperbilirubinaemia: a mixed method study

“…Of note, midwives considered their reliance on reading the visual aid while performing the test (which is standard practice in laboratories) a weakness and this aspect might need to be taken into account when training clinic field staff. Usability results obtained here might not be generalizable to every other context but there are data being collected in several rural and community-based settings that corroborate ease of use of this device to guide malaria treatment after appropriate training [26, 35, 36].…”