N/A N=1,754 Other

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

G6PD Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT04033640 ↗

Enrolled (actual)

1,754

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals — 100.0; 100.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SD Biosensor STANDARD G6PD Test (Diagnostic_test); Pointe Scientific Test Kit (Diagnostic_test); HemoCue System (Diagnostic_test); Complete blood count (CBC) (Diagnostic_test)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: PATH
Primary completion: Dec 2019

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	—

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

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

View full record on ClinicalTrials.gov →

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.