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 (CORDAGES)
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|ClinicalTrials.gov Identifier: NCT05074745|
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 27, 2021
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 COVID-19||Diagnostic Test: ELISA POCT vs RT-PCR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 18, 2021|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Buccal and nasopharyngeal swabs
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
3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR
- 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)
- Comparison of Ct values in buccal and nasopharyngeal swabs [ Time Frame: 48 Hours ]Ct values by PCR in buccal and nasopharyngeal swabs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074745
|Contact: Eric VOIGLIO, MD, PhDfirstname.lastname@example.org|
|Centre National de Depistage - Espace Leo Ferre||Recruiting|
|Monaco, Monaco, 98000|
|Contact: Eric VOIGLIO, MD, PhD +37798984850 email@example.com|
|Contact: Thomas ALTHAUS, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Eric VOIGLIO, MD, PhD|
|Sub-Investigator: Thomas ALTHAUS, MD, PhD|
|Sub-Investigator: Herve RAPS, MD|
|Sub-Investigator: Olivier DEJOUX, MD|
|Sub-Investigator: Patrick RAMPAL, MD|