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An Evaluation of a New Quantitative Point-of Care Diagnostic to Measure Glucose-6-phosphate Dehydrogenase Activity

  • Bahk, Young Yil (Department of Biotechnology, College of Biomedical and Health Science, Konkuk University) ;
  • Ahn, Seong Kyu (Infectious Diseases Investigation Division, Jeonnam Institute of Public Health and Environment) ;
  • Jeon, Heung Jin (Infection Control Convergence Research Center, Chungnam National University College of Medicine) ;
  • Na, Byoung-Kuk (Department of Parasitology and Tropical Medicine, Institute of Health Sciences, College of Medicine, Gyeongsang National University) ;
  • Lee, Sung-Keun (Department of Pharmacology, Inha University School of Medicine) ;
  • Shin, Ho-Joon (Department of Microbiology, Ajou University School of Medicine)
  • Received : 2022.05.24
  • Accepted : 2022.07.27
  • Published : 2022.08.31

Abstract

Malaria continues to be one of the most crucial infectious burdens in endemic areas worldwide, as well as for travelers visiting malaria transmission regions. It has been reported that 8-aminoquinolines are effective against the Plasmodium species, particularly primaquine, for anti-hypnozoite therapy in P. vivax malaria. However, primaquine causes acute hemolytic anemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Therefore, G6PD deficiency testing should precede hypnozoite elimination with 8-aminoquinoline. Several point-of-care devices have been developed to detect G6PD deficiency. The aim of the present study was to evaluate the performance of a novel, quantitative G6PD diagnostics based on a metagenomic blue fluorescent protein (mBFP). We comparatively evaluated the sensitivity and specificity of the G6PD diagnostic modality with standard methods using 120 human whole blood samples. The G6PD deficiency was spectrophotometrically confirmed. The performance of the G6PD quantitative test kit was compared with that of a licensed control medical device, the G6PD strip. The G6PD quantitative test kit had a sensitivity of 95% (95% confidence interval (CI): 89.3-100%) and a specificity of 100% (95% CI: 94.3-100%). This study shows that the novel diagnostic G6PD quantitative test kit could be a cost-effective and time-efficient, and universally mandated screening tool for G6PD deficiency.

Keywords

Acknowledgement

This study was supported by funding from the National Research Fund (NRF-2020R1F1A1070882, and NRF-2022R1F1A1066481) in the Republic of Korea, and the Bio and Medical Technology Development Program of the NRF funded by the Korean Government (MSIT) (2018M3A9H5055614).

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