Dry Versus Wet Nasopharyngeal Rapid Test for the Detection of COVID-19.

NCT04839094 | Completed

• 1 other identifier: Q2059
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study the investigators compare antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. The investigators conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland).

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2 diagnosis; RT-PCR; rapid antigen testing; saliva; viral transport medium

Outcome Measures

Primary Outcomes (1)

• Diagnostic assessment

  Comparison of diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the different strategies on patients hospitalised with a SARS-CoV-2 infection.

  On the day of inclusion

Secondary Outcomes (1)

• Limit of detection determination.

  On the day of inclusion

Interventions

rapid antigen testing versus RT-PCR DIAGNOSTIC_TEST

Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hospitalized patients with a confirmed SARS-CoV-2 infection will be screened for inclusion criteria.

You may qualify if:

• Hospitalized patients aged above 18 years with confirmed SARS-CoV-2 infection by RT-PCR assay.
• Provide informed consent.

You may not qualify if:

• Patient's refusal to participate in the study.
• Patients with negative RT-PCR if already performed for patient's follow up as part of standard care.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: December 10, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CH (1)