Status:
COMPLETED
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
Lead Sponsor:
PATH
Conditions:
G6PD Deficiency
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 assa...
Detailed Description
Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick cap...
Eligibility Criteria
Inclusion
- 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
- Blood transfusion in the past 3 months by self-report
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT04054661
Start Date
August 12 2019
End Date
January 31 2020
Last Update
November 9 2021
Active Locations (1)
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1
BSC corporation
Reading, Pennsylvania, United States, 19602