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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
| Herlev and Gentofte Hospital | OTHER |
| Odense University Hospital | OTHER |
| Aarhus University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of antigen tests with RT-PCR as reference method | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 3 days after first initial positive COVI-19 RT-PCR test |
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Inclusion Criteria:
Exclusion Criteria:
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approximately 4400 adult out-patients tested for SARS-CoV-2 by RT-PCR within 24 hours prior to inclusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| Hvidovre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35394449 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | May 30, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OTHER |
| Rigshospitalet, Denmark | OTHER |
| Slagelse Hospital | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Sygehus Lillebaelt | OTHER |
| Statens Serum Institut | OTHER |
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SARS-CoV-2 samples are collected from SARS-CoV-2 positive and negative individuals, analyzed and discharged
|
| 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. |
| Up to 3 days after first initial positive COVI-19 RT-PCR test. |
| Hvidovre |
| 2650 |
| Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |