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

Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil

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

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.

1. Participants with unknown G6PD status

   Inclusion criteria:

   • Febrile patients seeking care at the Manaus or Porto Velho clinics
   • 2 years age or older
   • Willing to provide informed consent

   Exclusion criteria

   • Younger than 2 years of age
   • Participants who received a blood transfusion in the last 3 months, self report
   • Unwilling to provide informed consent

2. Participants with known G6PD status

   Inclusion criteria:

   • Included in previous G6PD surveys and provided consent to be contacted again
   • 2 years of age or older
   • Willing to provide informed consent or assent

   Exclusion criteria:

   • Younger than 2 years of age
   • Participants who received a blood transfusion in the last 3 months, self report
   • Unwilling to provide informed consent or assent or unavailable during study visit

3. Health workers

Inclusion Criteria:

• Provides malaria case management at study facility or study site
• Considered an intended user of quantitative POC G6PD tests
• Trained and proficient in the use of the POC G6PD test
• Willing to provide informed consent

Exclusion Criteria:

• Does not provide malaria case management at study facility or study site
• Not considered an intended user of quantitative POC G6PD tests
• Not trained or not proficient in the use of the POC G6PD test
• Unwilling to provide informed consent