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The inclusion and exclusion criteria have become very restrictive, resulting in a very limited eligible population
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient infected or cured from covid19 | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :
The criteria for inclusion in the "acute point infection" group are as follows:
The criteria for inclusion in the "Sequential acute infection" group are as follows:
The criteria for inclusion in the "Convalescent" group are as follows:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | 760031 | France |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D007239 |
| Infections |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |