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| Name | Class |
|---|---|
| Mahidol University | OTHER |
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD Testing | No Intervention | All subjects receive G6PD test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G6PD Test | Other | All subjects are tested by multiple G6PD tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | six months |
| Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Nosten, MD/PhD | Shoklo Malaria Research Unit, Mahidol Oxford Research unit | Principal Investigator |
| Gonzalo Domingo, PhD | PATH | Study Chair |
| Germana Bancone, PhD | Shoklo Malaria Research Unit, Mahidol Oxford Research unit | Study Chair |
| Sarah McGray, MPH | PATH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoklo Malaria Research Unit (SMRU) | Mae Sot | Thailand |
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| ID | Term |
|---|---|
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests. |
| 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. | 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 | six months |
| Association between flow cytometry-based test and sample genotype | Determine accuracy of phenotypic results of flow cytometry assay against genetic profile. | Six months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |