Trials Sponsors Conditions Drugs Pricing

Conditions

Covid19 SARS-CoV-2

Keywords

AntigenRapidPoint of care testing

Outcome Measures

Primary Outcomes (1)

Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
30 days

Study Arms (1)

SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing

Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing.

Device: POC CoviDx™ Rapid Antigen Test

Interventions

POC CoviDx™ Rapid Antigen TestDevice

All patients will have a nasal swab for CoviDx™ Rapid Antigen testing

SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Year+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Symptomatic patients who are suspected of having SARS-CoV-2

You may qualify if:

Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection

Sponsors & Collaborators

Rapid Pathogen Screening
Industrycollaborator
Lumos Diagnostics
Industrylead

Study Sites (2)

Doral Medical Research

Hialeah, Florida, 33016, United States

Comprehensive Clinical Research

West Palm Beach, Florida, 33409, United States

Biospecimen

Retention: SAMPLES WITH DNA

Nasal Swabs

MeSH Terms

Conditions

COVID-19Fasting

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesFeeding BehaviorBehavior

Enrollment

140 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 11, 2021

Study Start

February 8, 2021

Actual (reported)

Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations