COVID-19RaDiCoNCT04613310
PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19)
A study testing Rapid Diagnostic Test vs PCR in people with COVID-19 and SARS-CoV-2, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Rapid Diagnostic Test vs PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 949 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient aged above 18 years who reports having at least one of the following symptoms: reported cough, reported fever, reported anosmia, or reported ageusia
Who cannot join
- Unwilling or incapable of informed consent
- Hospitalized patients
- Anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2: a Comparative Clinical Trial
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).
Read the 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.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Rapid Diagnostic Test vs PCR
- Keywords
- COVID-19, SARS-CoV-2, Saliva, Rapid Diagnostic Test, Antigen, PCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Diagnostic Test vs PCRDiagnostic test
Also called Saliva versus nasopharyngeal swab
4 swabs taken, saliva for PCR and RDT, nasopharyngeal for PCR and RDT
| Study group | Role | What they receive |
|---|---|---|
| Saliva and nasopharyngeal swabs | Other | One patient will have 4 swabs taken, 2 saliva for PCR and RDT, 2 nasopharyngeal for PCR and RDT Receives: Diagnostic Test: Rapid Diagnostic Test vs PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours
Secondary outcomes (1)
Viral loads of SARS-CoV-2 by PCR on saliva and nasopharyngeal swabs
Ct values by PCR in saliva and nasopharyngeal swab
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start25 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 4 components Nasopharyngeal swab by PCR Nasopharyngeal swab by RDT Saliva by PCR Saliva by RDT
- Masking
- None (open label)
- Enrolment
- 949 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Valérie D'Acremont, MD PhD, Principal investigator, Unisanté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613310
- Sponsor's protocol ID
- 2020-02269
- Acronym
- RaDiCo
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2020
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36827328
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2: a Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04613310
- Acronym / sponsor ID
- RaDiCo / 2020-02269
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, SARS-CoV-2, Saliva, Rapid Diagnostic Test, Antigen, PCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 949 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 4 components Nasopharyngeal swab by PCR Nasopharyngeal swab by RDT Saliva by PCR Saliva by RDT
| Arm | Type | Receives |
|---|---|---|
| Saliva and nasopharyngeal swabs | Other | Diagnostic Test: Rapid Diagnostic Test vs PCROne patient will have 4 swabs taken, 2 saliva for PCR and RDT, 2 nasopharyngeal for PCR and RDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatient aged above 18 years who reports having at least one of the following symptoms: reported cough, reported fever, reported anosmia, or reported ageusia
Key exclusion criteria (3 listed)
- Unwilling or incapable of informed consent
- Hospitalized patients
- Anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Diagnostic Test vs PCRAlso: Saliva versus nasopharyngeal swab4 swabs taken, saliva for PCR and RDT, nasopharyngeal for PCR and RDT | Diagnostic test | Saliva and nasopharyngeal swabs |
Primary outcome
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)
1 secondary outcome
Viral loads of SARS-CoV-2 by PCR on saliva and nasopharyngeal swabs
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 36827328Schwob 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie D'Acremont, MD PhD principal investigator
Unisanté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Diagnostic Test vs PCR in people with COVID-19 and SARS-CoV-2, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04613310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.