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

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).

Conditions

• Influenza
• COVID-19
• RSV Infection

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 & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-03

Primary Completion

2023-04-01

Completion

2023-07-01

Countries

• Denmark

Study Locations