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Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil
In Brief
A clinical study evaluating SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit, and 2 other interventions for G6PD Deficiency. Completed, enrolled 1,754 participants across 2 sites.
Detailed Summary
Th objectives of this study are: * To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay * To assess the comprehension of the G6PD test packaging and labelling among intended users * To assess the usability of G6PD test result outputs among intended users
Study Details
Timeline
Interventions
The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care (POC) setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in Brazil and is considered an investigational product.
The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.
The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.
In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).