Generic Testing of Antigen Tests for COVID-19 in Denmark
NCT ID: NCT04913116
Last Updated: 2022-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4000 participants
OBSERVATIONAL
2021-01-18
2021-09-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
Comparison of antigen tests with RT-PCR as reference method
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.
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
Comparison of antigen tests with RT-PCR as reference method
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.
Interventions
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Comparison of antigen tests with RT-PCR as reference method
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.
Eligibility Criteria
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Inclusion Criteria
* Capacity to give informed, written consent
* Be able to cooperate to the additional testing.
* Declining additional oropharyngeal, nasal or saliva swabs.
18 Years
ALL
Yes
Sponsors
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Aalborg University Hospital
OTHER
Herlev and Gentofte Hospital
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Slagelse Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Sygehus Lillebaelt
OTHER
Statens Serum Institut
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
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Uffe Schneider
Principal Investigator.
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Hvidovre University Hospital
Hvidovre, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Nat COVID Ag Project
Identifier Type: -
Identifier Source: org_study_id
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