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 Type
OBSERVATIONAL
Enrollment
4,000
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.
Aarhus University Hospital
Aarhus, Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
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
Time frame: 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.
Time frame: 2 months
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).
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.
Antigen an RT-PCR tests are performed from multiple anatomical sampling sites on each teste individual.
Time frame: Up to 3 days after first initial positive COVI-19 RT-PCR test.
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