Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva

Study Overview
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Brief Summary
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The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).

Detailed Description
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Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS). However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results. New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care. Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used. Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times. The main objective of the study is to evaluate, for the detection of SARS-CoV-2 infection, the performance of various alternative virological diagnostic strategies on saliva samples, in comparison with the reference technique (RT-PCR on NPS). The primary endpoint of the study is positivity of the standard technique (RT-PCR on NPS) for the SARS-CoV-2 virus. The result of the alternative strategies on a saliva sample will be considered as positive or negative according to criteria specific to each of them and compared to the result of the reference technique to estimate their respective sensitivity. The secondary objectives are to compare the diagnostic performances of RT-PCR on saliva versus RT-PCR on NPS, the diagnostic performances of alternative techniques on saliva versus RT-PCR on saliva, to evaluate the acceptability of the saliva self-sampling and the cost-effectiveness of new diagnostic strategies compared to the reference technique. The study will include adults and children in whom a NPS is performed for SARS-CoV-2 screening. After informed consent, participants will be asked to provide a saliva sample before nasopharyngeal sampling. Both samples will be analyzed in parallel. The analytical performance of each technique will be assessed, centrally or delocalised, depending on the feasibility of the techniques and according to the advice of the scientific board. The analyzes will be carried out by a team of technicians specifically recruited for the study. All samples collected will be stored in a centralized in a biobank.

Official Title
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Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)

Conditions
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SARS-CoV-2 Infection, COVID-19

Intervention / Treatment
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* Diagnostic Test: Nasopharyngeal swab
* Diagnostic Test: Saliva sample
* Diagnostic Test: axillary sweat sample
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult or child subject able to receive nasopharyngeal swab, regardless of age Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP Subject or parent not opposed to saliva sampling and data collection as part of this research Exclusion Criteria: None
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Salicov<br>Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab | Diagnostic Test: Nasopharyngeal swab<br>* Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test<br>Diagnostic Test: Saliva sample<br>* Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach<br>Diagnostic Test: axillary sweat sample<br>* Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.<br>Other: Data collection<br>* Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected<br>|
| SalicovII (ancillary study)<br>Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected. | Diagnostic Test: Saliva sample<br>* Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach<br>Other: Data collection<br>* Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus | RT-PCR on nasopharyngeal is considered as gold standard | At diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus |  | At diagnosis | 
| Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus |  | At diagnosis | 
| Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus |  | At diagnosis | 
| Practicability to samples | Number of samples tested in a day for each test | At diagnosis | 
| Practicability to premises | Quantity of premises required for each test | At diagnosis | 
| Practicability to interpretation | Feasibly Reading and interpretation For each test | At diagnosis | 
| Practicability to render time | Render times for each test | At diagnosis | 
| IgG Antibody detection in saliva | Research of IgG by ELISA and RDT | At diagnosis | 
| IgM Antibody detection in saliva | Research of IgM by ELISA and RDT | At diagnosis | 
| IgA Antibody detection in saliva | Research of IgA by ELISA and RDT | At diagnosis | 
| Positivity of canine olfactory detection of SARS-CoV-2 |  | At diagnosis | 
| Patient tolerance of the salivary self-sampling | Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance) | At diagnosis | 
| Operator tolerance of the salivary self-sampling | Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance) | At diagnosis | 
| Cost of each approach | Including sampling, transport, technique (consumables, reagents, machine), human resources | At diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening program, SARS-CoV-2 infection