Evaluation of Different G6PD Testing Platforms

Completed

• Conditions: Glucose-6-Phosphate Dehydrogenase Deficiency

• Registration Number: NCT02104518
• Lead Sponsor: PATH

Brief Summary

In this study the investigators propose to evaluate the performance of several G6PD testing platforms.

Detailed Description

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine concordance between point-of-care tests and spectrophotometric gold standard	Six months	Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.

Secondary Outcome Measures

Name	Time	Method
Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard	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	Six months	Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
Define the G6PD-normal and deficient profiles in the SW Sumba population.	Six months	Determine the profile of the SW Sumba area in regards to normal and deficient population spread.
Determine concordance between point-of-care G6PD tests and the florescent spot test	Six months	Compare sensitivity \& specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.

Trial Locations

Locations (1)

Eijkman Institute for Molecular Biology; 🇮🇩 Jakarta, Indonesia