Publication: 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
Issued Date
2019-01-01
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ISSN
00029637
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2-s2.0-85059798810
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Mahidol University
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SCOPUS
Bibliographic Citation
American Journal of Tropical Medicine and Hygiene. Vol.100, No.1 (2019), 213-221
Suggested Citation
Sampa Pal, Pooja Bansil, Germana Bancone, Sevan Hrutkay, Maria Kahn, Gornpan Gornsawun, Pimsupah Penpitchaporn, Cindy S. Chu, François Nosten, Gonzalo J. Domingo 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. American Journal of Tropical Medicine and Hygiene. Vol.100, No.1 (2019), 213-221. doi:10.4269/ajtmh.18-0612 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51147
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Title
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
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Abstract
Copyright © 2019 by The American Society of Tropical Medicine and Hygiene. 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.