Evaluation of Different G6PD Testing Platforms
In this study the investigators propose to evaluate the performance of several G6PD testing platforms.
Glucose-6-Phosphate Dehydrogenase Deficiency
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Evaluation of a Point-of-care G6PD Diagnostic Test|
- Determine concordance between point-of-care tests and spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.
- Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard.
- Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard [ Time Frame: Six months ] [ Designated as safety issue: No ]Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
- Determine concordance between point-of-care G6PD tests and the florescent spot test [ Time Frame: Six months ] [ Designated as safety issue: No ]Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.
- Define the G6PD-normal and deficient profiles in the SW Sumba population. [ Time Frame: Six months ] [ Designated as safety issue: No ]Determine the profile of the SW Sumba area in regards to normal and deficient population spread.
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||April 2014|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Blood samples will be tested for G6PD activity levels
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02104518
|Eijkman Institute for Molecular Biology|
|Study Chair:||Ari Winasti Satyagraha, PhD||Eijkman Institute for Molecular Biology|
|Study Chair:||Kevin Baird, PhD||Eijkman Oxford Clinical Research Unit|