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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 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2021-10-27

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

ELISA POCT vs RT-PCR

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

Sponsors & Collaborators

  • Department of Health Affairs, Monaco

    collaborator UNKNOWN

  • Centre Scientifique de Monaco

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • Monaco

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074745 on ClinicalTrials.gov