Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
Study Details
Study Description
Brief Summary
This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. We will include citizens attending outpatient test facilities at Testcenter Danmark Valby to obtain a RT-PCR test for COVID-19. They 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RT-PCR of upper airway specimens Saliva, nasopharyngeal, nasal, and oropharyngeal swabs will be collected on all participants and RT-PCR tested individually |
Diagnostic Test: Collection of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs
Collection of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
|
Outcome Measures
Primary Outcome Measures
- RT-PCR for upper airway viral diagnostics [1 day]
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
Secondary Outcome Measures
- local immunological mediators from the upper airway tract [1 day]
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).
Eligibility Criteria
Criteria
The inclusion criterion:
- 18 years or more of age requiring a test for COVID-19.
The exclusion criteria are :
-
Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
-
Do not understand oral or written Danish
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-23006949