Evaluation of Different G6PD Testing Platforms

Study Overview
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Brief Summary
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In this study the investigators propose to evaluate the performance of several G6PD testing platforms.

Detailed Description
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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.

Official Title
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Evaluation of a Point-of-care G6PD Diagnostic Test

Conditions
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Glucose-6-Phosphate Dehydrogenase Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be at least five years of age Patient / parental consent Patient willing to allow donated sample to be used in future research Exclusion Criteria: Patients with severe malaria or other severe illness Patients who received a blood transfusion in the last three months Patients unwilling to allow donated blood to be used in future research

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G6PD testing<br>Blood samples will be tested for G6PD activity levels | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine concordance between point-of-care tests and spectrophotometric gold standard | Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard | This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard. | Six months | 
| Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard | Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard | Six months | 
| Determine concordance between point-of-care G6PD tests and the florescent spot test | Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test. | Six months | 
| Define the G6PD-normal and deficient profiles in the SW Sumba population. | Determine the profile of the SW Sumba area in regards to normal and deficient population spread. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose-6-phosphate dehydrogenase, point-of-care diagnostic testing