Evaluation of Different G6PD Testing Platforms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||June 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|