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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
250
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Valby COVID19 testcenter
Copenhagen, Denmark
RECRUITINGRT-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
Time frame: 1 day
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).
Time frame: 1 day
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