Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

G6PD Deficiency Clinical Trial

Official title: Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood.

G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured.

Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples.

Another venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays:

• G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay

• hemoglobin measurement by a hematology analyzer

Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up. ;

Related Conditions & MeSH terms

• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency

• NCT number: NCT04010695
• Study type: Interventional
• Source: PATH
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Completion date: September 19, 2019