SARS-CoV2 InfectionNCT04913116
Generic Testing of Antigen Tests for COVID-19 in Denmark
An observational study of SARS-CoV2 Infection and COVID-19 Testing, run by Hvidovre University Hospital at 3 sites in Denmark.
Trial summary
To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, COVID-19 Testing
- What is being tested?
- Comparison of antigen tests with RT-PCR as reference method
- How many people
- 4,000 participants
- Where
- 3 sitesDenmark
- Study dates
- 18 Jan 2021to 9 Sep 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: approximately 4400 adult out-patients tested for SARS-CoV-2 by RT-PCR within 24 hours prior to inclusion.
Who may be able to join
- Age 18 years or over,
- Capacity to give informed, written consent
- Be able to cooperate to the additional testing.
Who cannot join
- Individuals not fulfilling the inclusion criteria
- Declining additional oropharyngeal, nasal or saliva swabs.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
Hvidovre University Hospital
Hvidovre, 2650
Odense University Hospital
Odense, 5000
About this study
Official title: Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With PCR, for Detecting SARS-CoV-2 in Adults: A Prospective Nationwide Observational Study
To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing.
For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status.
Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples.
30 companies with a total of 55 tests participate in this nationwide study.
- Conditions
- SARS-CoV2 Infection, COVID-19 Testing
- Being tested
- Comparison of antigen tests with RT-PCR as reference method
- Keywords
- antigen test, RT-PCR, Prospective samples, Retrospective samples
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of antigen tests with RT-PCR as reference methodDiagnostic test
Antigen tests are performed locally including sampling from multiple anatomical testing sites. A reference oropharyngeal swab is always send for RT-PCR for SARS-CoV-2 at DTU to verify the status of the patient. RT-PCR samples from other anatomical test locations may be included.
| Study group | Role | What they receive |
|---|---|---|
| SARS-Cov-2 positives | 200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location Receives: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method | |
| SARS-CoV-2 negatives | 200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location Receives: Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.
Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously
Measured: Up to 3 days after first initial positive COVI-19 RT-PCR test
Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.
SARS-CoV-2 positive samples are stratified into subgroups according to Cq by RT-PCR and frozen samples in universal transport medium is tested on each antigen test.
Measured: 2 months
Secondary outcomes (2)
Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq
Performance of each antigen test in relation to the cycle of quantification Cq by RT-PCR stratified into low (Cq <25), intermediate (Cq 25-35) and High (Cq >35).
Measured: Up to 3 days after first initial positive COVI-19 RT-PCR test
Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.
Antigen an RT-PCR tests are performed from multiple anatomical sampling sites on each teste individual.
Measured: Up to 3 days after first initial positive COVI-19 RT-PCR test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start18 Jan 2021
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
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 SARS-CoV2 InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Herlev and Gentofte Hospital, Odense University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Slagelse Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Sygehus Lillebaelt, Statens Serum Institut
- Responsible party
- Principal investigator, Uffe Schneider, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913116
- Sponsor's protocol ID
- Nat COVID Ag Project
- Status last verified
- Jan 2022
- First submitted
- 12 May 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schneider UV, Knudsen JD, Koch A, Kirkby NS, Lisby JG. An Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With Reverse Transcription Polymerase Chain Reaction for Detecting SARS-CoV-2 in Adults: Protocol for a Prospective Nationwide Observational Study. JMIR Res Protoc. 2022 May 4;11(5):e35706. doi: 10.2196/35706.
PubMed 35394449
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With PCR, for Detecting SARS-CoV-2 in Adults: A Prospective Nationwide Observational Study
- ClinicalTrials.gov ID
- NCT04913116
- Acronym / sponsor ID
- Nat COVID Ag Project
- Conditions
- SARS-CoV2 Infection, COVID-19 Testing
- Keywords
- antigen test, RT-PCR, Prospective samples, Retrospective samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Herlev and Gentofte Hospital, Odense University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Slagelse Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Sygehus Lillebaelt, Statens Serum Institut
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 4 Jun 2021 (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.
To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing.
For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status.
Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples.
30 companies with a total of 55 tests participate in this nationwide study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-Cov-2 positives | – | Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location |
| SARS-CoV-2 negatives | – | Diagnostic Test: Comparison of antigen tests with RT-PCR as reference method200 individuals will be tested by each antigen test. Testing is done with up to three swabs at a time from each anatomical test location |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- approximately 4400 adult out-patients tested for SARS-CoV-2 by RT-PCR within 24 hours prior to inclusion.
Key inclusion criteria (3 listed)
- Age 18 years or over,
- Capacity to give informed, written consent
- Be able to cooperate to the additional testing.
Key exclusion criteria (2 listed)
- Individuals not fulfilling the inclusion criteria
- Declining additional oropharyngeal, nasal or saliva swabs.
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 |
|---|---|---|
| Comparison of antigen tests with RT-PCR as reference methodAntigen tests are performed locally including sampling from multiple anatomical testing sites. A reference oropharyngeal swab is always send for RT-PCR for SARS-CoV-2 at DTU to verify the status of the patient. RT-PCR samples from other anatomical test locations may be included. | Diagnostic test | SARS-CoV-2 negatives, SARS-Cov-2 positives |
Primary outcome
Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result.
Time frame: Up to 3 days after first initial positive COVI-19 RT-PCR test
Performance is compared for each antigen test in relation to oropharyngeal RT-PCR samples collected simultaneously
Analytical sensitivity and specificity of each antigen test on retrospectively collected SARS-CoV-2 positive and negative samples.
Time frame: 2 months
SARS-CoV-2 positive samples are stratified into subgroups according to Cq by RT-PCR and frozen samples in universal transport medium is tested on each antigen test.
2 secondary outcomes
Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq
Time frame: Up to 3 days after first initial positive COVI-19 RT-PCR test
Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR.
Time frame: Up to 3 days after first initial positive COVI-19 RT-PCR test.
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 26 Jan 2022.
- Derived from this study: PubMed 35394449Schneider UV, Knudsen JD, Koch A, Kirkby NS, Lisby JG. An Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With Reverse Transcription Polymerase Chain Reaction for Detecting SARS-CoV-2 in Adults: Protocol for a Prospective Nationwide Observational Study. JMIR Res Protoc. 2022 May 4;11(5):e35706. doi: 10.2196/35706.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and COVID-19 Testing, run by Hvidovre University Hospital at 3 sites in Denmark.
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 3 inclusion and 2 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result. (time frame: Up to 3 days after first initial positive COVI-19 RT-PCR test). The study lists 2 primary outcomes in all. 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 NCT04913116, 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 26 Jan 2022.