Clinical Trial: Evaluation of Different G6PD Testing Platforms

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: PATH

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: April 1, 2014
Date Started: April 2014
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014