COVID-19 Testing, SARS-CoV2 Infection
Conditions
Keywords
antigen test, RT-PCR, Prospective samples, Retrospective samples
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTComparison 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.
Sponsors
Aalborg University Hospital
Herlev and Gentofte Hospital
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Slagelse Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Sygehus Lillebaelt
Statens Serum Institut
Hvidovre University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or over, * Capacity to give informed, written consent * Be able to cooperate to the additional testing.
Exclusion criteria
* Individuals not fulfilling the inclusion criteria * Declining additional oropharyngeal, nasal or saliva swabs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical sensitivity and specificity of each antigen test compared to RT-PCR test result. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical sensitivity compared to RT-PCR result with the later stratified into low, intermediate and high Cq | Up to 3 days after first initial positive COVI-19 RT-PCR test | 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). |
| Agreement between oropharyngeal swabs and tests from other anatomical test locations by RT-PCR. | Up to 3 days after first initial positive COVI-19 RT-PCR test. | Antigen an RT-PCR tests are performed from multiple anatomical sampling sites on each teste individual. |
Countries
Denmark
Outcome results
None listed