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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 is a study of COVID-19 that has completed, run by Freedom For All Diagnostics. The registered enrollment target is 232 participants, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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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.

Conditions Studied

COVID-19

Interventions

  • DEVICE SARS-CoV-2 Antigen Assay

Study Locations (1)

Maryland

  • Centennial Medical - Elkridge

Trial Details

FieldValue
Enrollment Target 232 participants
Start Date 2022-01-27
Est. Completion 2022-06-01

Sponsor

Freedom For All Diagnostics

1 total trials

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What the Registry Record Tells You About NCT05213897

The ClinicalTrials.gov registry entry for NCT05213897 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Freedom For All Diagnostics, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.