1,754
Participants
Start Date
June 27, 2019
Primary Completion Date
December 31, 2019
Study Completion Date
December 31, 2019
SD Biosensor STANDARD G6PD Test
"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."
Pointe Scientific Test Kit
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.
HemoCue System
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.
Complete blood count (CBC)
In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).
Tropical Medicine Foundation Doctor Heitor Vieira Dourado, Manaus
Centro de Pesquisa em Medicina Tropical de Rondônia, Porto Velho
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
OTHER
PATH
OTHER