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Field Trial of the CareStart Biosensor Analyzer for the Determination of Glucose-6-Phosphate Dehydrogenase Activity in Haiti

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  • 1 Herbert Wertheim College of Medicine, Florida International University, Miami, Florida;
  • | 2 Department of Global and Community Health, George Mason University, Fairfax, Virginia;
  • | 3 Department of Environmental and Global Health, University of Florida, Gainesville, Florida;
  • | 4 Emerging Pathogens Institute, University of Florida, Gainesville, Florida;
  • | 5 Christianville Foundation Clinic, Gressier, Haiti

Throughout many developing and tropical countries around the world, malaria remains a significant threat to human health. One barrier to malaria elimination is the ability to safely administer primaquine chemotherapy for the radical cure of malaria infections in populations with a high prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency. In the current study, a field trial of the world’s first quantitative, point-of-care assay for measuring G6PD activity was conducted in Haiti. The performance of the CareStart Biosensor Analyzer was compared with the gold standard spectrophotometric assay and genotyping of the G6PD allele in schoolchildren (N = 343) from the Ouest Department of Haiti. In this population, 19.5% of participants (67/343) had some form of G6PD deficiency (< 60% residual activity) and 9.9% (34/343) had moderate-to-severe G6PD deficiency (< 30% residual activity). Overall, 18.95% of participants had the presence of the A-allele (65/343) with 7.87% (27/343) considered at high risk for drug-induced hemolysis (hemizygous males and homozygous females). Compared with the spectrophotometric assay, the sensitivity and specificity to determine participants with < 60% residual activity were 53.7% and 94.6%, respectively; for participants with 30% residual activity, the sensitivity and specificity were 5.9% and 99.7%, respectively. The biosensor overestimated the activity in deficient individuals and underestimated it in participants with normal G6PD activity, indicating the potential for a systematic measurement error. Thus, we suggest that the current version of the biosensor lacks adequate sensitivity and should be improved prior to its use as a point-of-care diagnostic for G6PD deficiency.

Author Notes

Address correspondence to Bernard A. Okech, Emerging Pathogens Institute, University of Florida, 2055 Mowry Road, Gainesville, FL 32611. E-mail: bokech@ufl.edu

These authors contributed equally to this work.

Authors’ addresses: Thomas A. Weppelmann, Herbert Wertheim College of Medicine, Florida International University, Miami, FL, E-mail: twepp002@fiu.edu. Michael E. von Fricken and Elisa Aguenza, George Mason University, Global and Community Health, Fairfax, VA, E-mails: mvonfric@gmu.edu and echon@masonlive.gmu.edu. Tara D. Wilfong and Bernard A. Okech, Department of Environmental and Global Health, University of Florida, Gainesville, FL, and Emerging Pathogens Institute, University of Florida, Gainesville, FL, E-mails: twodoc@ufl.edu and bokech@ufl.edu. Taina T. Philippe, Christianville Clinic, Christianville Foundation Inc., Gressier, Haiti, E-mail: tainatelisma@yahoo.com.

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