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

PATH

Status: Completed

Conditions: G6PD Deficiency

Treatments: Diagnostic Test: HemoCue System; Diagnostic Test: SD Biosensor STANDARD G6PD Test; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: Complete blood count (CBC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04033640

G6PD Brazil

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,754 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,754 participants in 2 patient groups

G6PD Diagnostic Testing

Other group

Description:

Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed the SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only).

Treatment:

Diagnostic Test: Pointe Scientific Test Kit

Diagnostic Test: SD Biosensor STANDARD G6PD Test

Diagnostic Test: Complete blood count (CBC)

Diagnostic Test: HemoCue System

Health Workers

No Intervention group

Description:

Participants were trained on use of the SD Biosensor STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation.