부산대학교 도서관

Introduction: Screening for G6PD deficiency can inform disease management including malaria. Treatment with the antimalarial drugs primaquine and tafenoquine can be guided by point-of-care testing for G6PD deficiency. Methods and findings: Data from similar clinical studies evaluating the performance of the STANDARD G6PD Test (SD Biosensor, South Korea) conducted in Bangladesh, Brazil, Ethiopia, India, Thailand, the United Kingdom, and the United States were pooled. Test performance was assessed in a retrospective analysis on capillary and venous specimens. All study sites used spectrophotometry for reference G6PD testing, and either the HemoCue or complete blood count for reference hemoglobin measurement. The sensitivity of the STANDARD G6PD Test using the manufacturer thresholds for G6PD deficient and intermediate cases in capillary specimens from 4212 study participants was 100% (95% Confidence Interval (CI): 97.5%–100%) for G6PD deficient cases with <30% activity and 77% (95% CI 66.8%–85.4%) for females with intermediate activity between 30%–70%. Specificity was 98.1% (95% CI 97.6%–98.5%) and 92.8% (95% CI 91.6%–93.9%) for G6PD deficient individuals and intermediate females, respectively. Out of 20 G6PD intermediate females with false normal results, 12 had activity levels >60% on the reference assay. The negative predictive value for females with G6PD activity >60% was 99.6% (95% CI 99.1%–99.8%) on capillary specimens. Sensitivity among 396 P. vivax malaria cases was 100% (69.2%–100.0%) for both deficient and intermediate cases. Across the full dataset, 37% of those classified as G6PD deficient or intermediate resulted from true normal cases. Despite this, over 95% of cases would receive correct treatment with primaquine, over 87% of cases would receive correct treatment with tafenoquine, and no true G6PD deficient cases would be treated inappropriately based on the result of the STANDARD G6PD Test. Conclusions: The STANDARD G6PD Test enables safe access to drugs which are contraindicated for individuals with G6PD deficiency. Operational considerations will inform test uptake in specific settings. Author summary: The glucose-6-phosphate dehydrogenase (G6PD) enzyme helps red blood cells work properly. When the body does not have enough of this enzyme and is exposed to oxidative challenges, including certain foods and medicines, red blood cells break down faster than they are made, causing hemolytic anemia. Diagnostics tools for this common condition have been limited but now, new point of care tests are available that can screen more people who are unable to access laboratory services. This is particularly important for the treatment of vivax malaria, where the only treatment options require G6PD screening before administration. This research provides an evaluation of the diagnostic performance of one such tool, the STANDARD G6PD Test (SD Biosensor, South Korea), based on extensive data from multiple studies. These data show that the test can be used to safely identify people with G6PD deficiency, which will help ensure they do not receive contraindicated medicines. The research also provides specific estimates about how this test may impact malaria case management and treatment options. [ABSTRACT FROM AUTHOR]