N/A
N=229
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
G6PD Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT04054661 ↗Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Oct 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)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Jan 2020
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 |
83.3; 66.7 | — |
| PRIMARY Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals |
98.0; 99.0 | — |
| PRIMARY Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity |
94.2; 100.0 | — |
| SECONDARY Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit |
96.8; 98.2 | — |
| SECONDARY Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test |
96.4; 78.6 | — |
| SECONDARY Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer |
5.1; 4.7; 5.4; 6.6; 5.4; 4.7 | — |
| SECONDARY Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer |
11.9; 12.0; 11.8; 12.3; 11.6; 12.2 | — |
| SECONDARY Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature |
5.63; 5.44; 5.52; 5.82; 5.61; 5.78 | — |
| SECONDARY Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage |
5.6; 5.4; 5.5; 5.9; 5.7; 5.4 | — |
| SECONDARY Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature |
13.9; 14.2; 12.6; 14.2; 13.8; 13.0 | — |
| SECONDARY Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage |
13.9; 14.2; 12.6; 14.4; 14.3; 13.1 | — |
Summary
The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.
Eligibility Criteria
Inclusion Criteria
- Must communicate an understanding of the study protocol.
- Must be able to provide written consent to undergo screening and provide medical history.
- Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
- Black/African-American, by self-report.
Exclusion Criteria
- Blood transfusion in the past 3 months by self-report
Data sourced from ClinicalTrials.gov (NCT04054661). 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.