SARS-CoV-2CORDAGESNCT05074745
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
A study testing ELISA POCT vs RT-PCR in people with SARS-CoV-2 and COVID-19, run by Centre Scientifique de Monaco at 1 site in Monaco.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- ELISA POCT vs RT-PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteMonaco
- Study dates
- 18 Feb 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ patient eligible for COVID-19 testing in Monaco
- symptoms suggestive of COVID-19
- contact with a confirmed case of COVID-19
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Monaco1 site, 1 recruiting
- Recruiting
Centre National de Depistage - Espace Leo Ferre
Monaco, 98000
Eric VOIGLIO, MD, PhD, +37798984850, evoiglio@gouv.mc
Thomas ALTHAUS, MD, PhD, talthaus@gouv.mc
About this study
Official title: 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: the CORDAGES Study
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
- Being tested
- ELISA POCT vs RT-PCR
- Keywords
- SARS-CoV-2, POCT, RT-PCR, Contact case, ELISA, Buccal
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA POCT vs RT-PCRDiagnostic test
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR
| Study group | Role | What they receive |
|---|---|---|
| Buccal and nasopharyngeal swabs | Experimental | One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR Receives: Diagnostic Test: ELISA POCT vs RT-PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 Hours
Secondary outcomes (1)
Comparison of Ct values in buccal and nasopharyngeal swabs
Ct values by PCR in buccal and nasopharyngeal swabs
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start18 Feb 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Scientifique de Monaco
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health Affairs, Monaco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074745
- Sponsor's protocol ID
- PRO_CSM_01_2021
- Acronym
- CORDAGES
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40399889
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: the CORDAGES Study
- ClinicalTrials.gov ID
- NCT05074745
- Acronym / sponsor ID
- CORDAGES / PRO_CSM_01_2021
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- SARS-CoV-2, POCT, RT-PCR, Contact case, ELISA, Buccal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Scientifique de MonacoUniversity, hospital or other
- Collaborators
- Department of Health Affairs, Monaco
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
| Arm | Type | Receives |
|---|---|---|
| Buccal and nasopharyngeal swabs | Experimental | Diagnostic Test: ELISA POCT vs RT-PCROne patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ patient eligible for COVID-19 testing in Monaco
- symptoms suggestive of COVID-19
- contact with a confirmed case of COVID-19
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA POCT vs RT-PCR3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR | Diagnostic test | Buccal and nasopharyngeal swabs |
Primary outcome
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)
Time frame: 48 Hours
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)
1 secondary outcome
Comparison of Ct values in buccal and nasopharyngeal swabs
Time frame: 48 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 40399889Althaus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA POCT vs RT-PCR in people with SARS-CoV-2 and COVID-19, run by Centre Scientifique de Monaco at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric VOIGLIO, MD, PhD (+37798984850, evoiglio@gouv.mc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 48 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.