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)

Centre Scientifique de Monaco

Status

Unknown

Conditions

COVID-19

SARS-CoV-2

Treatments

Diagnostic Test: ELISA POCT vs RT-PCR

Study type

Interventional

Funder types

Other

Identifiers

NCT05074745

PRO_CSM_01_2021

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.