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

Not Applicable

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Diagnostic Test: ELISA POCT vs RT-PCR

• Registration Number: NCT05074745
• Lead Sponsor: Centre Scientifique de Monaco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-18
• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-12
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-27
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Buccal and nasopharyngeal swabs	ELISA POCT vs RT-PCR	One patient will have 3 swabs taken, 2 buccal for PCR and ELISA POCT, 1 nasopharyngeal for PCR

Primary Outcome Measures

Name	Time	Method
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)	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)

Secondary Outcome Measures

Name	Time	Method
Comparison of Ct values in buccal and nasopharyngeal swabs	48 Hours	Ct values by PCR in buccal and nasopharyngeal swabs

Trial Locations

Locations (1)

Centre National de Depistage - Espace Leo Ferre; 🇲🇨 Monaco, Monaco