Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

Study Overview
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Brief Summary
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Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

Official Title
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Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

Conditions
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CoV2 Positive Caregivers

Intervention / Treatment
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* Diagnostic Test: Serological tests will be applied on patients blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL. Age: ≥ 18 years old Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months. Persons affiliated to a social security scheme or beneficiary of such a scheme. Exclusion Criteria: Pregnant or lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serological tests will be applied on patients blood sampling<br>Serological tests will be applied on patients blood sampling | Diagnostic Test: Serological tests will be applied on patients blood sampling<br>* Application of tests on patients' serum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 0 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 3 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 7 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 14 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 21 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 28 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 35 | 
| The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of IgM and IgG antibody titer at each sampling of weekly and monthly visits of covid-19+ patients and implementation of the kinetics of mean appearance. |  | Day 42 | 
| - Among the symptomatic PCR negative patients recruited into the study at the first visit, the measurement of the IgM antibody and IgG titer will be performed in serum at D28, and the positive results will then constitute the false-negative PCR results. |  | Day 28 | 
| - Measurement of IgM and IgG antibody titer at each sampling of late patient visits. |  | Day 42 | 
| - The neutralizing capacity of the antibodies will be determined by in vitro serum neutralization tests on seropositive serum. A group of 50 patients made up of seropositive and asymptomatic caregivers at the time of infection will represent this group. |  | Day 42 |