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

Am J Trop Med Hyg. 2019 Jan;100(1):213-221. doi: 10.4269/ajtmh.18-0612.

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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimalarials / therapeutic use
  • Clinical Enzyme Tests / methods
  • Clinical Enzyme Tests / standards*
  • Female
  • Glucosephosphate Dehydrogenase / blood*
  • Glucosephosphate Dehydrogenase Deficiency / blood
  • Glucosephosphate Dehydrogenase Deficiency / diagnosis*
  • Humans
  • Malaria, Vivax / complications
  • Malaria, Vivax / drug therapy
  • Male
  • Point-of-Care Testing / standards*
  • Reagent Kits, Diagnostic / standards*
  • Sensitivity and Specificity
  • Thailand
  • United States
  • Young Adult

Substances

  • Antimalarials
  • Reagent Kits, Diagnostic
  • Glucosephosphate Dehydrogenase