An observational study in SARS-CoV-2 Infection and COVID-19, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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).
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 5,197 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Exclusion Criteria:
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Diagnostic Test: Nasopharyngeal swab · Diagnostic Test: Saliva sample · Diagnostic Test: axillary sweat sample · Other: Data collection
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 · Other: Data collection
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus
RT-PCR on nasopharyngeal is considered as gold standard
Time frame: At diagnosis
Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus
Time frame: At diagnosis
Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus
Time frame: At diagnosis
Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus
Time frame: At diagnosis
Practicability to samples
Number of samples tested in a day for each test
Time frame: At diagnosis
Practicability to premises
Quantity of premises required for each test
Time frame: At diagnosis
Practicability to interpretation
Feasibly Reading and interpretation For each test
Time frame: At diagnosis
Practicability to render time
Render times for each test
Time frame: At diagnosis
IgG Antibody detection in saliva
Research of IgG by ELISA and RDT
Time frame: At diagnosis
IgM Antibody detection in saliva
Research of IgM by ELISA and RDT
Time frame: At diagnosis
IgA Antibody detection in saliva
Research of IgA by ELISA and RDT
Time frame: At diagnosis
Positivity of canine olfactory detection of SARS-CoV-2
Time frame: 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)
Time frame: 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)
Time frame: At diagnosis
Cost of each approach
Including sampling, transport, technique (consumables, reagents, machine), human resources
Time frame: At diagnosis
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris