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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients

NCT ID: NCT05074745

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2021-12-30

Brief Summary

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The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab.

Secondary objectives

* To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay.
* Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms.
* Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test.
* The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.

Detailed Description

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Conditions

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SARS-CoV-2 COVID-19

Keywords

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SARS-CoV-2 POCT RT-PCR Contact case ELISA Buccal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Buccal and nasopharyngeal swabs

One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR

Group Type EXPERIMENTAL

ELISA POCT vs RT-PCR

Intervention Type DIAGNOSTIC_TEST

3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR

Interventions

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ELISA POCT vs RT-PCR

3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18+ patient eligible for COVID-19 testing in Monaco
* symptoms suggestive of COVID-19
* contact with a confirmed case of COVID-19

Exclusion Criteria

* refusal to participate in the study
* preventive screening of professional groups
* inability to return to the screening center within 48-72 hours of the first visit.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health Affairs, Monaco

UNKNOWN

Sponsor Role collaborator

Centre Scientifique de Monaco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre National de Depistage - Espace Leo Ferre

Monaco, , Monaco

Site Status RECRUITING

Countries

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Monaco

Central Contacts

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Eric VOIGLIO, MD, PhD

Role: CONTACT

Phone: +37798984850

Email: [email protected]

Facility Contacts

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Eric VOIGLIO, MD, PhD

Role: primary

Thomas ALTHAUS, MD, PhD

Role: backup

References

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Althaus T, Blake A, Costantini A, Lavagna C, Jacquesson E, Groshenry G, Troel A, Vanzo B, Dejoux O, Raps H, Rampal P, Voiglio EJ. Diagnostic accuracy of non-invasive SARS-CoV-2 screening tests: a national prospective analysis. BMC Infect Dis. 2025 May 21;25(1):727. doi: 10.1186/s12879-025-11088-x.

Reference Type DERIVED
PMID: 40399889 (View on PubMed)

Other Identifiers

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PRO_CSM_01_2021

Identifier Type: -

Identifier Source: org_study_id