Evaluation of the Diagnostic Accuracy of the Quantitative Point-of-Care SD Biosensor Standard G6PD Test for Assessment of G6PD Deficiency in Infectious Diseases.

BACKGROUND: G6PD deficiency affects about 500 million people worldwide and is prevalent in many malaria-endemic settings. People with G6PD deficiency are at risk of hemolysis when exposed to certain medications, including 8-aminoquinoline drugs used to treat Plasmodium vivax malaria. Increasing access to testing for G6PD deficiency at or near the point of care is critical to expanding the safe treatment of P. vivax malaria. We aimed to evaluate the performance of a semiquantitative test for G6PD deficiency, the SD Biosensor Standard G6PD Test with the Brewer's method, in a reference site for the treatment of infectious diseases. METHOD: We evaluate the diagnostic accuracy performance of the SD Biosensor Standard G6PD Test in 125 individuals with infectious diseases and other illnesses. MAIN RESULTS: We observed a trend of concordance between the G6PD status (Deficient or Normal), with low frequencies of discordances in the screenings. The strength of agreement between G6PD tests was classified as almost perfect in all participants (k = 0.82, 95% CI = 0.66, 0.97) and in sex subgroups: females (k = 0.83, 95% CI = 0.59, 1.00) and males (k = 0.81, 95% CI = 0.59, 1.00). The total concordance percentage (number of concordances/total) was 95% for females, 97% for males, and 96% overall. CONCLUSION: The SD Biosensor STANDARD G6PD test is an innovative point-of-care solution. It offers quantitative measurement of glucose-6-phosphate dehydrogenase activity while normalizing for hemoglobin levels. This advancement enables its use in lower-tier clinical and laboratory settings, expanding access to accurate G6PD testing.