Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
1 other identifier
interventional
250
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedStudy Start
First participant enrolled
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMarch 28, 2023
March 1, 2023
29 days
March 1, 2023
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
local immunological mediators from the upper airway tract
1 day
Study Arms (12)
Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)
EXPERIMENTAL1 NPS right - Nasal swab left - OPS NPS = nasopharyngeal swab OPS = oropharyngeal swab
Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)
EXPERIMENTAL2 NPS left - Nasal swab right - OPS
Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)
EXPERIMENTAL3 Nasal swab right - NPS left - OPS
Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)
EXPERIMENTAL4 Nasal swab left - NPS right - OPS
Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)
EXPERIMENTAL5 NPS right - OPS - Nasal swab left
Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)
EXPERIMENTAL6 NPS left - OPS - Nasal swab right
Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)
EXPERIMENTAL7 Nasal swab right - OPS - NPS left
Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)
EXPERIMENTAL8 Nasal swab left - OPS - NPS right
Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)
EXPERIMENTAL9 OPS - NPS right - Nasal swab left
Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)
EXPERIMENTAL10 OPS - NPS left - Nasal swab right
Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)
EXPERIMENTAL11 OPS - Nasal swab left - NPS right
Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)
EXPERIMENTAL12 OPS - Nasal swab right - NPS left
Interventions
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
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Valby COVID19 testcenter
Copenhagen, Denmark
Related Publications (1)
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.
PMID: 41247054DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Phd, Consultant, Ass. Prof
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
March 3, 2023
Primary Completion
April 1, 2023
Study Completion
July 1, 2023
Last Updated
March 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL