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

Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

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.

Study Overview

• Status: Recruiting
• Conditions: Corona Virus Infection
• Intervention / Treatment: Diagnostic test: Serological testing for COVID-19 infection

• Study Type: Interventional
• Enrollment (Anticipated): 385
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Christophe Plantier, Professor; Phone Number: 02 32 88 66 72; Email: Jc.plantier@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 760031
    • Recruiting
    • Rouen university hospital
    • Contact: David Mallet
    • Contact: Email: secretariat.dcr@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :

• 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.

The criteria for inclusion in the "acute point infection" group are as follows:

• 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

The criteria for inclusion in the "Sequential acute infection" group are as follows:

• 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

The criteria for inclusion in the "Convalescent" group are as follows:

• Caregivers working at the UH of Rouen
• Screened by positive RT-PCR for SARS-CoV-2 infection,
• Healed for at least one month at the time of inclusion
• Having read and understood the briefing note and signed the informed consent form

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient infected or cured from covid19; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay	Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: 2020/0126/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No