COVID-19, Influenza, RSV Infection
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TEST(NPS right - Nasal swab left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(NPS left - Nasal swab right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(Nasal swab right - NPS left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(Nasal swab left - NPS right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(NPS right - OPS - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(NPS left - OPS - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(Nasal swab right - OPS - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(Nasal swab left - OPS - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(OPS - NPS right - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(OPS - NPS left - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(OPS - Nasal swab left - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
DIAGNOSTIC_TEST(OPS - Nasal swab right - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The order of the swabs performed will be decided with randomization to either of the eight combination: 1. NPS right - Nasal swab left - OPS 2. NPS left - Nasal swab right - OPS 3. Nasal swab right - NPS left - OPS 4. Nasal swab left - NPS right - OPS 5. NPS right - OPS - Nasal swab left 6. NPS left - OPS - Nasal swab right 7. Nasal swab right - OPS - NPS left 8. Nasal swab left - OPS - NPS right 9. OPS - NPS right - Nasal swab left 10. OPS - NPS left - Nasal swab right 11. OPS - Nasal swab left - NPS right 12. OPS - Nasal swab right - NPS left
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Denmark
Contacts
Primary ContactTobias Todsen, MD
Outcome results
None listed