N/A
Completed N=1,754
Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil
G6PD Deficiency
Source: ClinicalTrials.gov NCT04033640 ↗
Enrolled (actual)
1,754
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals — 100.0; 100.0 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals |
100.0; 100.0 | — |
| PRIMARY Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity |
96.9; 94.3 | — |
| PRIMARY Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals |
98.6; 97.8 | — |
| PRIMARY Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity |
96.5; 92.3 | — |
| SECONDARY Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit |
96.7; 94.1 | — |
| SECONDARY Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test |
93.3; 91.8 | — |
| SECONDARY Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count |
93.1; 93.2 | — |
| SECONDARY Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples |
8.0; 7.6 | <0.001 sig |
| SECONDARY Number of Participants Who Met Acceptance Criteria for Label Comprehension |
10 | — |
| SECONDARY Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation |
16 | — |
Eligibility Criteria
- 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
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04033640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.