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
NCT ID: NCT04578509
Last Updated: 2026-01-15
Study Results
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Basic Information
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COMPLETED
5197 participants
OBSERVATIONAL
2020-10-19
2021-06-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
axillary sweat sample
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
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.
Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
Interventions
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Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
axillary sweat sample
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jérôme Le Goff, Professor
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP)
Paris, , France
Countries
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References
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To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
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Other Identifiers
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2020-A02431-38
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200960
Identifier Type: -
Identifier Source: org_study_id
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