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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
All subjects are tested by multiple G6PD tests
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Thailand
Correlation of capillary and venous blood results using Trinity quantitative G6PD test
Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.
Time frame: Six months
Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard
Percent agreement between the quantitative results of the flow cytometry assay and the quantitative results of the spectrophotometric assay.
Time frame: six months
Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping
Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests.
Time frame: six months
Concordance between a qualitative G6PD test and the spectrophotometric gold standard
Compare sensitivity \& specificity of qualitative results of the G6PD test and the categorical results of the quantitative spectrophotometric assay.
Time frame: Six months
Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard
Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
Time frame: six months
Association between flow cytometry-based test and sample genotype
Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.
Time frame: Six months
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