Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

NCT04707833 | Terminated

• 1 other identifier: 2020/0126/HP
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months. In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay

  Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )

  24 months

Secondary Outcomes (1)

• Evaluation of immunological of EUROIMMUN SARS-CoV-2(IgA) ELISA, EUROIMMUN SARS-CoV-2 (IgG) ELISA, WANTAI SARS-CoV-2 Ab ELISA, WANTAI SARS-CoV-2 IgM ELISA, Diasorin LIAISON SARS CoV-2 S1/S2 IgG, Roche ECL anti-SARS-Cov-2 (combined IgG IgA)

  24 months

Study Arms (1)

Patient infected or cured from covid19

EXPERIMENTAL

* Patients with an acute SARS-CoV-2 infection confirmed by a positive RT-PCR, hospitalized in COVID units or in COVID resuscitations, * Nurses at the Rouen University Hospital infected with COVID 19, and cured, * Patients with a high suggestive clinic for COVID-19 infection but with negative COVID-19 RT-PCR

Diagnostic Test: Serological testing for COVID-19 infection

Interventions

Serological testing for COVID-19 infection DIAGNOSTIC_TEST

The tests used will be the following: EUROIMMUN SARS-CoV-2(IgA) ELISA ELISA SARS-CoV-2 (IgG) EUROIMMUN WANTAI SARS-CoV-2 Ab ELISA WANTAI SARS-CoV-2 IgM ELISA Abbott Architect SARS-CoV-2 IgG Diasorin SARS LINK CoV-2 S1/S2 IgG Roche ECL anti-SARS-Cov-2 (combined IgG IgM IgA)

Patient infected or cured from covid19

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020)
• Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus)
• Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen.
• Patients screened by a positive RT-PCR for an SARS-CoV-2 infection
• Patients aged ≥ 18 years old
• Patients taken in charge in the emergency room / in a unit / in COVID resuscitation at the Rouen University Hospital.
• Patients having read and understood the briefing note
• Non-opposition to participation in the study
• Patients with positive RT-PCR for CoV-2-SARS infection
• Patients aged ≥ 18 years old
• Taken care of in a COVID unit at the Rouen University Hospital
• Having read and understood the briefing note and signed the informed consent form
• Caregivers working at the UH of Rouen
• Screened by positive RT-PCR for SARS-CoV-2 infection,
• Having read and understood the briefing note and signed the informed consent form

You may not qualify if:

• Minor person
• Known Pregnancy
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
• Person not affiliated with social security
• Person who does not understand and speak French

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 760031, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 13, 2021
• Study Start: November 26, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: April 29, 2026

Record last verified: 2026-02

Locations

FR (1)