Evaluation of Different G6PD Testing Platforms

Evaluation of a Point-of-care G6PD Diagnostic Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02104518

Enrollment

700

Registered

2014-04-04

Start date

2014-04-30

Completion date

2014-06-30

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose-6-Phosphate Dehydrogenase Deficiency

Keywords

glucose-6-phosphate dehydrogenase, point-of-care diagnostic testing

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.
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.

Countries

Indonesia

Outcome results