Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
Study NCT ID:
NCT04010695
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2019-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Sponsor:
PATH
Organization:
Study Overview
Official Title:
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: