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

NCT04613310 | Completed

• 1 other identifier: 2020-02269
• Study Type: interventional
• Target: 949
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; SARS-CoV-2

Keywords

COVID-19; SARS-CoV-2; Saliva; Rapid Diagnostic Test; Antigen; PCR

Outcome Measures

Primary Outcomes (1)

• Proportion of SARS-CoV-2 positive patients for the two different sampling types (saliva vs nasopharyngeal) and two methods (RDT vs PCR) .

  Number of SARS-CoV-2 positive patients by sampling type (saliva and nasopharyngeal swab) and analytical method (RDT and PCR)

  48 hours

Secondary Outcomes (1)

• Viral loads of SARS-CoV-2 by PCR on saliva and nasopharyngeal swabs

  48 hours

Study Arms (1)

Saliva and nasopharyngeal swabs

OTHER

One patient will have 4 swabs taken, 2 saliva for PCR and RDT, 2 nasopharyngeal for PCR and RDT

Diagnostic Test: Rapid Diagnostic Test vs PCR

Interventions

Rapid Diagnostic Test vs PCR DIAGNOSTIC_TEST

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

Also known as: Saliva versus nasopharyngeal swab

Saliva and nasopharyngeal swabs

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Outpatient aged above 18 years who reports having at least one of the following symptoms: reported cough, reported fever, reported anosmia, or reported ageusia

You may not qualify if:

• Unwilling or incapable of informed consent
• Hospitalized patients
• Anticoagulation

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

Unisanté

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Schwob JM, Miauton A, Petrovic D, Perdrix J, Senn N, Gouveia A, Jaton K, Opota O, Maillard A, Minghelli G, Cornuz J, Greub G, Genton B, D'Acremont V. Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: A prospective comparative clinical trial. PLoS One. 2023 Feb 24;18(2):e0282150. doi: 10.1371/journal.pone.0282150. eCollection 2023.

  PMID: 36827328 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Valérie D'Acremont, MD PhD

  Unisanté

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 components Nasopharyngeal swab by PCR Nasopharyngeal swab by RDT Saliva by PCR Saliva by RDT

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 3, 2020
• Study Start: September 25, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

CH (1)