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.
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
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
SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP)
Paris, France
Jérôme Le Goff, Professor, Study Director
Assistance Publique - Hôpitaux de Paris