Last Updated: 29/10/2025
Validation of a diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency in anti-coagulated blood
Objectives
To assess the accuracy of a point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.
BioIVT, United States
University of Washington (UW), United States
G6PD status is particularly relevant for the treatment and prevention of malaria. Malaria is prevented and treated using a variety of treatments, some of which pose a high risk to those with G6PD deficiency. The 8-aminoquinoline–based malaria drugs for treatment and prophylaxis such as primaquine and tafenoquine are the only ones with the capacity to prevent relapse and eliminate the liver stage parasites in Plasmodium (P.) vivax infections. Due to the risks associated to G6PD deficiency for primaquine, WHO recommends that “the G6PD status of patients should be used to guide administration of primaquine for preventing relapse”.
Current tests for measuring G6PD activity are complex and require sophisticated laboratory facilities to execute [7-10]. Quantitative enzyme activity-based tests are considered by WHO and the US Food and Drug Administration (FDA) as the true gold standard for classifying G6PD status in individuals. The Pointe Scientific test (Cat No. G7583) is one of the few FDA-cleared products which use the accepted gold standard assay conditions for evaluation of novel G6PD tests. The Pointe Scientific test (Cat No. G7583) run in a College of American Pathologists (CAP) certified laboratory will be used as the reference standard for the evaluation.
ClinicalTrials.gov ID: NCT04054661
This is a prospective cross-sectional diagnostic accuracy study with a nested repeatability study and a nested sample stability study
Aug 2019 — Jan 2020
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