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Completed

NCT Number: NCT02104518

Evaluation of Different G6PD Testing Platforms

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

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Key information

Conditions

Glucose-6-Phosphate Dehydrogenase Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eijkman Institute for Molecular Biology

Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Eijkman Institute for Molecular Biology

Registry information

Official study title

Evaluation of a Point-of-care G6PD Diagnostic Test

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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