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

NCT05074745 | Unknown

• 1 other identifier: PRO_CSM_01_2021
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2; COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients for the two different sampling types (buccal vs nasopharyngeal) and two methods (ELISA POCT vs RT-PCR)

  Number of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients by sampling type (buccal and nasopharyngeal swab) and analytical method (ELISA POCT vs RT-PC)

  48 Hours

Secondary Outcomes (1)

• Comparison of Ct values in buccal and nasopharyngeal swabs

  48 Hours

Study Arms (1)

Buccal and nasopharyngeal swabs

EXPERIMENTAL

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

Diagnostic Test: ELISA POCT vs RT-PCR

Interventions

ELISA POCT vs RT-PCR DIAGNOSTIC_TEST

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

Buccal and nasopharyngeal swabs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Scientifique de Monaco: lead
• Department of Health Affairs, Monaco: collaborator

Study Sites (1)

Centre National de Depistage - Espace Leo Ferre

Monaco, 98000, Monaco

RECRUITING

Related Publications (1)

• 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.

  PMID: 40399889 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Eric VOIGLIO, MD, PhD

CONTACT

+37798984850; evoiglio@gouv.mc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 12, 2021
• Study Start: February 18, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)