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This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS) | Experimental | 1 NPS right - Nasal swab left - OPS NPS = nasopharyngeal swab OPS = oropharyngeal swab |
|
| Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS) | Experimental | 2 NPS left - Nasal swab right - OPS |
|
| Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS) | Experimental | 3 Nasal swab right - NPS left - OPS |
|
| Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS) | Experimental | 4 Nasal swab left - NPS right - OPS |
|
| Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left) | Experimental | 5 NPS right - OPS - Nasal swab left |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (NPS right - Nasal swab left - OPS) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| Measure | Description | Time Frame |
|---|---|---|
| RT-PCR for upper airway viral diagnostics | the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| local immunological mediators from the upper airway tract | measure interferon γ (IFN-γ), C-X-C motif chemokine 10 (CXCL10/IP10), interleukin 10 (IL-10), interleukin 12p70, interleukin 13 (IL-13), interleukin 1β (IL-1β), interleukin 2, interleukin 4 (IL-4), interleukin 5 (IL-5), interleukin 6, CXCL8, tumor necrosis factor α (TNF-α), C-C motif chemokine 5 (CCL5/RANTES), interferon α2a, and granulocyte macrophage colony-stimulating factor (GM-CSF). |
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The inclusion criterion:
A. 18 years or more of age requiring a test for COVID-19.
The exclusion criteria are :
A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
B. Do not understand oral or written Danish
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Todsen, MD | Contact | +35453545 | tobias.todsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valby COVID19 testcenter | Recruiting | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41247054 | Derived | Lopez-Perez M, Benfield T, Jakobsen KK, Dal MH, Stange SD, Ersboll AK, Larsen H, Berger SS, Gredal T, Buchwald Cv, Kirkby N, Todsen T. Diagnostic performance of upper airway sampling sites for SARS-CoV-2 and influenza testing. Microbiol Spectr. 2026 Jan 6;14(1):e0221225. doi: 10.1128/spectrum.02212-25. Epub 2025 Nov 17. |
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The order of the swabs performed will be decided with randomization to either of the eight combination:
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| Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right) | Experimental | 6 NPS left - OPS - Nasal swab right |
|
| Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left) | Experimental | 7 Nasal swab right - OPS - NPS left |
|
| Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right) | Experimental | 8 Nasal swab left - OPS - NPS right |
|
| Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left) | Experimental | 9 OPS - NPS right - Nasal swab left |
|
| Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right) | Experimental | 10 OPS - NPS left - Nasal swab right |
|
| Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right) | Experimental | 11 OPS - Nasal swab left - NPS right |
|
| Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left) | Experimental | 12 OPS - Nasal swab right - NPS left |
|
| (NPS left - Nasal swab right - OPS) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (Nasal swab right - NPS left - OPS) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (Nasal swab left - NPS right - OPS) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (NPS right - OPS - Nasal swab left) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (NPS left - OPS - Nasal swab right) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (Nasal swab right - OPS - NPS left) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (Nasal swab left - OPS - NPS right) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (OPS - NPS right - Nasal swab left) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (OPS - NPS left - Nasal swab right) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (OPS - Nasal swab left - NPS right) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| (OPS - Nasal swab right - NPS left) | Diagnostic Test | Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order |
|
| 1 day |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
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