Evaluation of a Novel Quantitative Test for Glucose-6-Phosphate Dehydrogenase Deficiency: Bringing Quantitative Testing for Glucose-6-Phosphate Dehydrogenase Deficiency Closer to the Patient

Abstract

Abstract.Glucose-6-phosphate dehydrogenase (G6PD) deficiency, a common genetic blood condition, can result in kernicterus at birth, and later in life as severe hemolysis on exposure to certain infections, foods, and drugs. The unavailability of point-of-care tests for G6PD deficiency is a barrier to routine curative treatment of Plasmodium vivax malaria with 8-aminoquinolines, such as primaquine. Two quantitative reference tests (Trinity Biotech, Bray, Ireland and Pointe Scientific, Canton, MI; Cat No. G7583) and the point-of-care STANDARD™ G6PD test (SD Biosensor, Suwon, South Korea) were evaluated. The STANDARD G6PD test was evaluated at multiple temperatures, in anticoagulated venous and capillary samples, including 79 G6PD-deficient and 66 intermediate samples and across two laboratories, one in the United States and one in Thailand. The STANDARD test performed equivalently to a reference assay for its ability to diagnose G6PD deficiency (< 30% normal) with a sensitivity of 100% (0.95 confidence interval [CI]: 95.7–100) and specificity of 97% (0.95 CI: 94.5–98.5), and could reliably identify females with less than 70% normal G6PD activity with a sensitivity of 95.5% (0.95 CI: 89.7–98.5) and specificity of 97% (0.95 CI: 94.5–98.6). The STANDARD G6PD product represents an opportunity to diagnose G6PD deficiency equally for males and females in basic clinical laboratories in high- and low-resource settings. This quantitative point-of-care diagnostic test for G6PD deficiency can provide equal access to safe radical cure of P. vivax cases in high- and low-resource settings, for males and females and may support malaria elimination, in countries where P. vivax is endemic.

Implementing Radical Cure Diagnostics for Malaria: User Perspectives on G6PD Testing in Bangladesh

“…A quantitative assay is therefore a much safer tool to guide radical cure treatment decisions. A novel handheld biosensor (STANDARD™ G6PD, SD Biosensor, Republic of Korea) (15,16), has been developed for use in point-of-care settings in endemic areas that could potentially address this shortfall.…”

Quantification of glucose-6-phosphate dehydrogenase activity by spectrophotometry: A systematic review and meta-analysis

“…The universal thresholds defined in our study are based on the Trinity assay kit, which is now discontinued. While Alam and colleagues have shown good correlation between Trinity measurements and results from a Pointe Scientific assay, with little difference in absolute measurements (n = 50, [14]), a study by Pal and colleagues found a more modest correlation in absolute measurements (n = 183; [13]). Consequently, demonstration of suitability of a proposed universal threshold will need to be demonstrated with each specific assay prior to its widespread endorsement and application.…”

“…Ultraviolet (UV) spectrophotometry is the reference standard diagnostic method for quantifying G6PD enzyme activity [12]. Multiple commercial assay kits are available, and although there is strong correlation of measurements between assays, absolute values vary [13,14]. Such absolute values will be important for the universal use of novel point-of-care quantitative diagnostics, such as forthcoming biosensors.…”

Mass drug administrations with dihydroartemisinin-piperaquine and single low dose primaquine to eliminate Plasmodium falciparum have only a transient impact on Plasmodium vivax: Findings from randomised controlled trials

“…Robust and accurate point-of-care tests for the diagnosis of G6PD deficiency could play a pivotal role in the elimination of vivax malaria. A range of new diagnostic tests is currently in development [29,30]. Second, high participation in mass treatment programmes is critical in clearing asymptomatic reservoirs.…”