Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood

Completed · Not applicable

Conditions studied: G6PD Deficiency

In brief

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.

Key facts

Study ID

NCT04054661

Run by

PATH

People needed

229

Starts

2019-08-12

Expected to finish

2020-01-31

Last updated by the study team

2021-11-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Blood transfusion in the past 3 months by self-report

Where it is running

• BSC corporation — Reading, Pennsylvania, United States

Full record on ClinicalTrials.gov

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