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| Name | Class |
|---|---|
| Eijkman Institute for Molecular Biology | OTHER |
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In this study the investigators propose to evaluate the performance of several G6PD testing platforms.
In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD testing | Blood samples will be tested for G6PD activity levels |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine concordance between point-of-care tests and spectrophotometric gold standard | Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard | This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard. | Six months |
| Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.
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| Name | Affiliation | Role |
|---|---|---|
| Ari Winasti Satyagraha, PhD | Eijkman Institute for Molecular Biology | Study Chair |
| Kevin Baird, PhD | Oxford University Clinical Research Unit Indonesia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eijkman Institute for Molecular Biology | Jakarta | Indonesia |
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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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Left-over venous blood will be spun down and buffy coat and extracted DNA will be stored in labeled tubes for later G6PD genotyping and characterization.
Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard |
| Six months |
| Determine concordance between point-of-care G6PD tests and the florescent spot test | Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test. | Six months |
| Define the G6PD-normal and deficient profiles in the SW Sumba population. | Determine the profile of the SW Sumba area in regards to normal and deficient population spread. | 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 |