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NCT05213897 · ClinicalTrials.gov registry record
Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings
A clinical trial of COVID-19, sponsored by Freedom For All Diagnostics.
- Completed
- Registry status
- 232
- Enrollment target
- 1
- Study location
NCT05213897: Completed study of COVID-19, sponsored by Freedom For All Diagnostics.
NCT05213897 is a study of COVID-19 that has completed, run by Freedom For All Diagnostics. The registered enrollment target is 232 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213897, a study of COVID-19, has completed, sponsored by Freedom For All Diagnostics.
- COMPLETED
- Registry status
- 232 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.
Primary Outcome
SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method.
Conditions Studied
Interventions
- DEVICE SARS-CoV-2 Antigen Assay
Study Locations (1)
Maryland
- Centennial Medical - Elkridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2022-06-01 |
What the finished NCT05213897 record still lists
NCT05213897 is an observational study that tracks outcomes without assigning an intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which SARS-CoV-2 Antigen Assay is the first listed.
NCT05213897 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05213897 about?
NCT05213897 is a clinical study titled "Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings". The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accurac...
What is the current status of trial NCT05213897?
This trial is currently completed. The enrollment target is 232 participants. The study started on 2022-01-27. Estimated completion is 2022-06-01.
What conditions does trial NCT05213897 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT05213897?
The interventions under investigation include: SARS-CoV-2 Antigen Assay (DEVICE).
Who is sponsoring clinical trial NCT05213897?
This trial is sponsored by Freedom For All Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213897 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05213897's enrollment target sits among peer trials
232 153rd of 298 higher than 146 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 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.
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