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

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ClinicalTrials.gov Identifier: NCT04613310
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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).


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Diagnostic Test: Rapid Diagnostic Test vs PCR Not Applicable

Detailed Description:

Background:

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, patients 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).

Methods:

Procedures:

Patients fulfilling inclusion and exclusion criteria will be recruited consecutively. After confirmation of inclusion and exclusion criteria, patients will be asked whether they would be willing to provide two saliva samples and one nasopharyngeal swab in addition to that provided for routine testing. After written informed consent, patients will be asked to perform swabbing of the gingiva-buccal fold two times and a saliva sample under professional supervision, once for sending to the laboratory to perform PCR, and once for performing the RDT onsite according to manufacturer's information. They will also be taken two nasopharyngeal swabs, one for RDT and one for PCR. No coughing or sniffing prior to sample collection is required. Ideally, water should be avoided 10 minutes prior to collection. Other drinks, food, and nasal sprays should be avoided 20 minutes before sample collection.

The saliva and nasopharyngeal samples will be analysed by PCR according to the standard procedure.

The RDTs will be performed and results read according to the manufacturer information (see below). Alternatively one of the three following tests will be tested: RDT from Roche (Standard Q COVID-19, the RDT from Abbott (Panbio COVID-19 Ag) and the RDT from AAZ-LMB (COVID-VIRO).

The patient will be considered as positive for SARS-CoV-2 if any of the test results (by RDT, or PCR on saliva or nasopharynx) is positive.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 4 components Nasopharyngeal swab by PCR Nasopharyngeal swab by RDT Saliva by PCR Saliva by RDT
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2: a Comparative Clinical Trial
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Saliva and nasopharyngeal swabs
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
4 swabs taken, saliva for PCR and RDT, nasopharyngeal for PCR and RDT
Other Name: Saliva versus nasopharyngeal swab




Primary Outcome Measures :
  1. Proportion of SARS-CoV-2 positive patients for the two different sampling types (saliva vs nasopharyngeal) and two methods (RDT vs PCR) . [ Time Frame: 48 hours ]
    Number of SARS-CoV-2 positive patients by sampling type (saliva and nasopharyngeal swab) and analytical method (RDT and PCR)


Secondary Outcome Measures :
  1. Viral loads of SARS-CoV-2 by PCR on saliva and nasopharyngeal swabs [ Time Frame: 48 hours ]
    Ct values by PCR in saliva and nasopharyngeal swab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613310


Contacts
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Contact: Valérie D'Acremont, MD PhD +41 79 556 25 51 valerie.dacremont@unisante.ch
Contact: Blaise Genton, MD PhD +41 79 556 58 68 blaise.genton@unisante.ch

Locations
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Switzerland
Unisanté Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Valerie D'Acremont, MD-PhD    +41 79 556 25 51    valerie.dacremont@unisante.ch   
Contact: Blaise Genton, MD-PhD    +41 79 556 58 68    blaise.genton@unisante.ch   
Principal Investigator: Valerie D'Acremont, MD-PhD         
Sub-Investigator: Blaise Genton, MD, PhD, MPH         
Sub-Investigator: Gilbert Greub, MD, PhD         
Sponsors and Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Valérie D'Acremont, MD PhD Unisanté
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Responsible Party: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT04613310    
Other Study ID Numbers: 2020-02269
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland:
COVID-19
SARS-CoV-2
Saliva
Rapid Diagnostic Test
Antigen
PCR