NCT02069236

Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. As secondary endpoints we will seek to correlate phenotype as determined by quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test evaluation studies.

Detailed description

In this study we propose to determine the correlation in glucose-6 phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. We will also compare results of different G6PD tests with known G6PD genetic profiles. The results of the study will inform design of future G6PD diagnostic development \& evaluations. This research will be conducted in MaeSot Thailand, where G6PD deficiency has a high prevalence. Study participants will be recruited into three groups of 50 volunteers per group: 50 G6PD-deficient individuals, 50 G6PD-normal individuals, and 50 G6PD-intermediate individuals. Following a written informed consent, participants will donate about 3 ml of venous blood and about 4 drops of capillary blood (fingerstick). There will be no direct benefit to research participants.

Conditions

• Glucose-6 Phosphate Dehydrogenase Deficiency

Interventions

Type	Name	Description
OTHER	G6PD Test	All subjects are tested by multiple G6PD tests

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2014-02-24
• Last updated: 2015-08-19

Locations

1 site across 1 country: Thailand