N/A
Completed N=250
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
G6PD Deficiency
Source: ClinicalTrials.gov NCT04010695 ↗
Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals — 100.0; 100.0 percentage of participants
Summary
The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals |
100.0; 100.0 | — |
| PRIMARY Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity |
100.0; 75.0 | — |
| PRIMARY Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals |
94.9; 98.5 | — |
| PRIMARY Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity |
83.7; 92.4 | — |
| SECONDARY Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit |
85.7; 93.9 | — |
| SECONDARY Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test |
97.5; 89.6 | — |
| SECONDARY Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples |
7.6; 6.8 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
-Willingness to provide consent
Exclusion Criteria
-Blood transfusion in the past 90 days by self-report
Data sourced from ClinicalTrials.gov (NCT04010695). 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.