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Diagnostic Accuracy of 2 cm Versus 4 cm Insertion Depth for Nasal Swabs for SARS-CoV-2 (COVID-19) Rapid Antigen Testing-A Randomized Controlled Trial
Sponsor: Rigshospitalet, Denmark
Summary
This study aims to compare the diagnostic accuracy of rapid antigen detection tests (RDTs) for SARS-CoV-2 using nasal swab insertion depths of 2 cm versus 4 cm. The study is an investigator-initiated, randomized clinical trial conducted at a public COVID-19 test center in Copenhagen, Denmark. Following enrollment, participants complete a questionnaire regarding symptoms and vaccination status. Participants are randomized in a 1:1 ratio to one of two sampling sequences: either a 2 cm swab in the left nostril and a 4 cm swab in the right nostril, or vice versa. All participants undergo a healthcare worker-collected throat swab for RT-PCR analysis, which serves as the reference standard for SARS-CoV-2 infection.
Official title: Diagnostic Accuracy of 2 cm Versus 4 cm Insertion Depth for Nasal Swabs for SARS-CoV-2 Rapid Antigen Testing-A Randomized Controlled Trial
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
317
Start Date
2023-02-01
Completion Date
2023-02-26
Last Updated
2026-05-19
Healthy Volunteers
Yes
Conditions
Interventions
4 cm nasal swab - left nostril
a 4 cm nasal swab insertion in the left nostril
2 cm nasal swab in the left nostril
a 2 cm nasal swab insertion in the left nostril
4 cm nasal swab - right nostril
a 4 cm nasal swab insertion in the right nostril
2 cm nasal swab - right nostril
a 2 cm nasal swab insertion in the right nostril
Locations (1)
Rigshospitalet
Copenhagen, Denmark