NCT04033640

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

Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,754 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants. The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests. The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.

Conditions

• G6PD Deficiency

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-06-27
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-07-26
• Last updated: 2021-11-11
• Results posted: 2021-11-11

Locations

2 sites across 1 country: Brazil