Introduction: The Ethiopian Federal Ministry of Health aims to eliminate malaria by 2030. Widespread use of radical cure drugs, primaquine or tafenoquine, to treat Plasmodium vivax will contribute to this goal. Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a genetic enzyme deficiency that impacts the safety of radical cure drugs. Evidence regarding local prevalence, tools to screen for G6PD deficiency at the point of care (POC), and strategies to operationalize these findings are needed to support this ambitious goal.
Methods: Select literature assessing the prevalence of G6PD deficiency in Ethiopia using multiple methods, including targeted and national surveys using genetic testing, were reviewed. A prospective diagnostic accuracy study was conducted to assess the performance and usability of the SD Biosensor STANDARD™ G6PD Test (Republic of Korea), a POC test for G6PD deficiency classification. Volunteers were recruited at Jimma University and clinics in Agaro and Gambella. G6PD and hemoglobin measurements were obtained using the STANDARD G6PD Test and HemoCue 201+ at the POC. Tests were repeated on venous samples, and spectrophotometric G6PD and hemoglobin reference assays were performed.
Results and conclusions: The literature suggests that there is a low prevalence of G6PD deficiency in Ethiopia with geographic heterogeneity. The most prevalent genetic mutation is G6PD A and clinically severe mutations have not been reported. The prospective diagnostic study confirms this, with 12 and 20 participants testing G6PD deficient and intermediate by the reference assay, respectively. The STANDARD G6PD Test demonstrated 100% (95% CI [73.5–100.0]) sensitivity and 99.3% (95% CI [98.5–99.7]) specificity in the classification of G6PD deficient people. The test demonstrated lower performance in the classification of G6PD intermediate females, with 52.6% (95% CI [28.9–75.6]) sensitivity and 94.7% (95% CI [92.2–96.6]) specificity. These data suggest that POC testing is appropriate in settings with a low prevalence of G6PD deficiency.