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 (SALICOV)

March 6, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

5197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75001
        • SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Diagnostic test: Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Diagnostic test: Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Diagnostic test: axillary sweat sample
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
SalicovII (ancillary study)
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
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: Jérôme Le Goff, Professor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

June 9, 2021

Study Completion (Actual)

June 9, 2021

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200960
  • 2020-A02431-38 (Other Identifier: APHP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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