Comparing G6PD Tests Using Capillary Blood Versus Venous Blood
|ClinicalTrials.gov Identifier: NCT02069236|
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glucose-6 Phosphate Dehydrogenase Deficiency||Other: G6PD Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: G6PD Testing
All subjects receive G6PD test
Other: G6PD Test
All subjects are tested by multiple G6PD tests
- Correlation of capillary and venous blood results using Trinity quantitative G6PD test [ Time Frame: Six months ]Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.
- Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard [ Time Frame: six months ]Percent agreement between the quantitative results of the flow cytometry assay and the quantitative results of the spectrophotometric assay.
- Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping [ Time Frame: six months ]Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests.
- Concordance between a qualitative G6PD test and the spectrophotometric gold standard [ Time Frame: Six months ]Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the quantitative spectrophotometric assay.
- Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard [ Time Frame: six months ]Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
- Association between flow cytometry-based test and sample genotype [ Time Frame: Six months ]Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069236
|Shoklo Malaria Research Unit (SMRU)|
|Mae Sot, Thailand|
|Principal Investigator:||Francois Nosten, MD/PhD||Shoklo Malaria Research Unit, Mahidol Oxford Research unit|
|Study Chair:||Gonzalo Domingo, PhD||PATH|
|Study Chair:||Germana Bancone, PhD||Shoklo Malaria Research Unit, Mahidol Oxford Research unit|
|Study Chair:||Sarah McGray, MPH||PATH|