Evaluation of Different G6PD Testing Platforms
|ClinicalTrials.gov Identifier: NCT02104518|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : October 28, 2014
|Condition or disease|
|Glucose-6-Phosphate Dehydrogenase Deficiency|
|Study Type :||Observational|
|Actual Enrollment :||700 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Evaluation of a Point-of-care G6PD Diagnostic Test|
|Study Start Date :||April 2014|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
Blood samples will be tested for G6PD activity levels
- Determine concordance between point-of-care tests and spectrophotometric gold standard [ Time Frame: Six months ]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 ]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 ]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 ]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 ]Determine the profile of the SW Sumba area in regards to normal and deficient population spread.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|