Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-03

Study Completion Date

2023-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Influenza COVID-19 RSV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)

1 NPS right - Nasal swab left - OPS

NPS = nasopharyngeal swab OPS = oropharyngeal swab

Group Type EXPERIMENTAL