Evaluation of Different G6PD Testing Platforms

Overview

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

Full Title of Study: “Evaluation of a Point-of-care G6PD Diagnostic Test”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2014

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.

Arms, Groups and Cohorts

  • G6PD testing
    • Blood samples will be tested for G6PD activity levels

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PATH
  • Collaborator
    • Eijkman Institute for Molecular Biology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ari Winasti Satyagraha, PhD, Study Chair, Eijkman Institute for Molecular Biology
    • Kevin Baird, PhD, Study Chair, Eijkman Oxford Clinical Research Unit

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