Clinical validation study of the STANDARD™ G6PD test

Study to evaluate the performance of a novel, semi-quantitative point-of-care G6PD test - the STANDARD™ G6PD Test (commercialized by SD Biosensor, Republic of Korea) - as compared to a spectrophotometric reference assay in the detection of G6PD activity.

Primary Objective:

• To assess the accuracy and reliability of G6PD tests in detecting G6PD activity and classifying results when used by trained health care workers in Brazil. 

Component Objectives:

• 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.

The study has been completed and the report will be forthcoming.