COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne (AntiCoV-HB)

Study Overview
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Brief Summary
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Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.

Detailed Description
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The first cases of the new coronavirus disease 2019 (COVID-19) due to the SARS-CoV-2 virus were reported in December 2019 in Wuhan, China. Since that date, a significant circulation of the virus around the world has been observed, justifying that WHO described the situation as pandemic on March 11. Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization. In the general population, only one recent study in France, in the Oise, one of the first clusters in France, reports a seroconversion rate of 35% in the area concerned [7]. This study used three different tests (ELISA, S-FLOW, LIPS assays) to define seroconversion (people were considered positive if at least one of the tests reported the presence of Anti SARS CoV 2 Antibodies). The proportion of people infected in Brittany, estimated by modeling work, would be 1.8% [1.1% -3.3%]. At the present time, no data exist to our knowledge on the seroprevalence of anti SARS-CoV-2 antibodies in healthcare populations. Many serological tests are currently being validated. The Rennes University Hospital, thanks to the support of the NOMINOE fund, will offer all employees of the territory hospital group (GHT) Haute-Bretagne to participate in this seroprevalence study using the serological test from the company NG-Biotech. It is a device of the type rapid serological diagnostic orientation test (TROD) which can be carried out outside medical biology laboratories by a doctor / pharmacist who is not a biologist or a nurse. This test provides a result in about fifteen minutes. The NG-Biotech test has a CE / IVD mark (pending opinion from the Institut Pasteur). An assessment of the sensitivity and specificity of the test was carried out at the CHU Kremlin Bicêtre and CHU Paul Brousse. From a sample of 101 COVID-19 patients (diagnosed by RT-PCR on nasopharyngeal or pulmonary samples) and 50 negative controls (30 pre-pandemic sera from September and October 2017 and 20 sera from patients tested COVID- 19 negative by RT-PCR without any symptoms for more than 15 days) a sensitivity of 97% [88.7% - 99.4%] and a specificity of 100% [91.1% -100%] were obtained 15 days after the first signs of COVID-19 patients. If the validity of the test is very good in this study, its main limitation is that it was carried out with a group of COVID-19 patients who were in the vast majority hospitalized (84% of patients) and therefore not representative of pauci or asymptomatic patients . Consequently, given the absence of consolidated data on the immune response based on clinical pictures, it is relevant to continue validation in a population of employees in which we wish to carry out this seroprevalence study and where the majority of infections did not lead to hospitalization. In addition, it is also necessary to obtain other data, in particular concerning the inter-observer reproducibility of the test which has not yet been studied. The need to validate the test in pauci or asymptomatic populations and to obtain reproducibility data was underlined in the opinion of the HAS on the methods for evaluating the performance of serological tests detecting antibodies directed against SARS-CoV -2.

Official Title
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COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne

Conditions
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Coronavirus

Intervention / Treatment
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* Diagnostic Test: NG test
* Diagnostic Test: Blood test
* Behavioral: Self-questionnary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Employees of voluntary establishments of GHT Haute-Bretagne Employees over the age of 18 Having signed a free, informed and written consent. Exclusion Criteria: Employees subject to legal protection (safeguard of justice, guardianship, curatorship)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-center cross-sectional survey at risk and minimal constraints, among GHT Haute Bretagne employees in order to know the prevalence of the presence of anti-SARS-CoV-2 antibodies. For a sample of employees with no additional prospective follow-up will be done on D30 and D90.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Seroprevalence survey<br>NG Test + short self-questionnaire (except validation survey and detailed survey) | Diagnostic Test: NG test<br>* rapid diagnosis Covid 19<br>Behavioral: Self-questionnary<br>* behavioral survey<br>|
| Other: Validation test of the NG test survey<br>Blood test + NG test + detailed self-questionnaire | Diagnostic Test: NG test<br>* rapid diagnosis Covid 19<br>Diagnostic Test: Blood test<br>* sample<br>Behavioral: Self-questionnary<br>* behavioral survey<br>|
| Other: Detailed Survey<br>NG test + self-questionnaire complementary to the short questionnaire | Diagnostic Test: NG test<br>* rapid diagnosis Covid 19<br>Behavioral: Self-questionnary<br>* behavioral survey<br>|
| Other: Prevalence monitoring (2 population samples)<br>Participants having presented a certain or probable COVID: acts of the validation test survey, + follow-up questionnaire,+ blood test + NG test, on D30 and D90 Others Participants : drawn by lot: acts of the seroprevalence survey, + follow-up questionnaire + NG test, on D90 | Diagnostic Test: NG test<br>* rapid diagnosis Covid 19<br>Diagnostic Test: Blood test<br>* sample<br>Behavioral: Self-questionnary<br>* behavioral survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment. | Rate of presence | at inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Validation of the Biotech NG test: | Sensitivity | at inclusion visit | 
| a) Validation of the Biotech NG test: | Specificity | at inclusion visit | 
| a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG | agreement between observers (kappa coefficient) | at inclusion visit | 
| a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM. | agreement between observers (kappa coefficient) | at inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | Demographic characteristics (age, sex) | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Professional characteristics (establishment, profession, service). | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Management of confirmed or probable COVID-19 patients | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - From contact with confirmed or probable COVID-19 professionals. | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - From contact in his personal circle with COVID-19 confirmed or probable persons. | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Episodes of symptoms suggestive of COVID-19 | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The existence of a chronic immunomodulatory pathology | At inclusion visit | 
| b) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The existence of smoking | At inclusion visit | 
| c) Risk of presence of anti SARS-CoV-2 antibodies in function: | - The use of materials adapted to good hygiene practices | At inclusion visit | 
| c) Risk of presence of anti SARS-CoV-2 antibodies in function: | - Service organization | At inclusion visit | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who changed their tobacco consumption | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of the reasons for modifying tobacco consumption | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who changed their alcohol consumption | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of the reasons for modification of alcohol consumption | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who have changed their eating habits | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of sleep changes | at Day 0 | 
| d) Description of the experience and behavioral changes related to the epidemic, | depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of lived experience and perceived stress | at Day 0 | 
| e) Evolution of seroprevalence over time: | For employees identified as COVID certain or probable * Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90. | At Day30 | 
| e) Evolution of seroprevalence over time: | For employees identified as COVID certain or probable * Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90. | At Day 90 | 
| e) Evolution of seroprevalence over time: | For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 | At Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid 19, SRAS-CoV-2