Comparing G6PD Tests Using Capillary Blood Versus Venous Blood
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|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.
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): 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|