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PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19)

NCT04613310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 949

Last updated 2025-10-06

No results posted yet for this study

Summary

Recent literature shows that the sensitivity of the PCR tests for the detection of SARS-CoV-2 using saliva samples is close to that using nasopharyngeal swabs. This type of sampling represents a practical advantage since it can be performed by the patient herself/himself and would thus allow to speed up the collection process. It is also less painful and could prevent the rare lesions to the nasal mucosa that can occur when using nasopharyngeal swabs.

Rapid Diagnostic Tests for the detection of SARS-CoV-2 antigens have been developed using nasophayngeal swabs and have shown very high sensitivity against PCR, ranging from 93% to 98% when based on laboratory validation, 80% when based on clinical validation.This method offers the considerable advantage to inform the patient of the test result on site, and allow the provision of appropriate recommendations on the spot of testing. The studies performed so far have been conducted using nasopharyngeal samples only. There are no data with saliva yet. It is expected that the RDT would also work on the saliva. Even if slightly less sensitive due to the fact that it detects antigens and not multiplied RNA as PCR does, RDT on saliva could better serve the public health goal to test widely and quickly and have ultimately more COVID cases detected and isolated, and hence reduced transmission.

To investigate the case detection rates of both PCR on saliva and nasopharynx and RDT on nasopharynx and saliva, the patient will be taken four samples, two swabs on saliva, one for RDT and one for PCR, and two swabs on nasopharynx, one for RDT and one for PCR. Patients who have at least one of the common symptoms and who consent to such a procedure will be recruited to compare the four results. The primary objective is to compare the case detection rates for SARS-CoV-2 of the four testing methods (two sampling types and two test types).

Conditions

Interventions

DIAGNOSTIC_TEST

Rapid Diagnostic Test vs PCR

4 swabs taken, saliva for PCR and RDT, nasopharyngeal for PCR and RDT

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

    lead OTHER

Principal Investigators

  • Valérie D'Acremont, MD PhD · Unisanté

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Switzerland

Study Locations

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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 NCT04613310 on ClinicalTrials.gov