Evaluation of the Sofia SARS Antigen FIA Assay for COVID-19

NCT04953091 | Unknown

• 1 other identifier: ESADEC ( 29BRC21.0117)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluating the performance of the Sofia SARS Antigen FIA

Conditions

SARS-CoV2 Infection

Keywords

SARS-CoV2 Infection; Assessment; EIA; Diagnosis

Outcome Measures

Primary Outcomes (1)

• assessment Vs gold standard

  PCR results and Ct values for specimens tested are collected and compared with Sofia results.

  Up to 35 positive PCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two nasopharyngeal swabs will be taken per included patient. One will be analyzed by RT-PCR in the virology laboratory, the other will be analyzed on site with the Sofia SARS Antigen FIA test. The results of the two tests will then be compared. These samples will not be collected for further research.

You may qualify if:

• Adult patient (\> or = 18 years of age)
• Patient with symptoms of COVID-19 (Rhinitis, throat pain, nasal congestion or other signs of local manifestation of the disease in the upper respiratory tract, including loss of taste, with or without additional systemic symptoms such as fatigue, fever, muscle pain...) whose health condition does not require hospitalization (mild to moderate disease)
• Patient with these symptoms for 5 days or less with a median of 3 to 4 days.
• Patient with consent to participate in the study

You may not qualify if:

• Patient with an age below 18 years
• Patient under legal protection (guardianship, curatorship)
• Patient without upper respiratory tract symptoms
• Patients with symptoms for more than 5 days
• Patient with previous COVID-19 diagnosed by RT-PCR
• Patient vaccinated against SARS-CoV-2 (1 or 2 injections)
• Hospitalized patient
• Refusal to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Centre de dépistage - CHRU BREST

Brest, 29200, France

RECRUITING

CHRU de brest

Brest, 29609, France

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adissa TRAN

CONTACT

02.98.14.50.96; adissa.tran-minoui@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 7, 2021
• Study Start: May 12, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three month and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)