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NCT04010695 · ClinicalTrials.gov registry record · NA
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
A NA study, sponsored by PATH.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT04010695: Completed NA study, sponsored by PATH.
NCT04010695 is a NA study that has completed, run by PATH. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04010695, a NA study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study 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.
Primary Outcome
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test. Diagnostic sensitivity of the SD Biosensor G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calcul
Interventions
- DIAGNOSTIC_TEST Pointe Scientific Test Kit
- DIAGNOSTIC_TEST HemoCue System
- DIAGNOSTIC_TEST SD Biosensor G6PD Analyzer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2019-09-19 |
| Phase | NA |
What the finished NCT04010695 record still lists
NCT04010695 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Pointe Scientific Test Kit is the first listed.
NCT04010695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04010695 about?
NCT04010695 is a clinical study titled "Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US". 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.
What is the current status of trial NCT04010695?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2019-05-13. Estimated completion is 2019-09-19.
What interventions are being tested in trial NCT04010695?
The interventions under investigation include: Pointe Scientific Test Kit (DIAGNOSTIC_TEST), HemoCue System (DIAGNOSTIC_TEST), SD Biosensor G6PD Analyzer (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04010695?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04010695's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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