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Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil

NCT04033640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1754

Last updated 2021-11-11

Study results available
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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

Conditions

  • G6PD Deficiency

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Complete blood count (CBC)

In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).

Sponsors & Collaborators

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Marcus Lacerda, MD, PhD · FMT/HVD

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033640 on ClinicalTrials.gov