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
NCT07597889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317
Last updated 2026-05-19
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.
Conditions
- COVID -19
Interventions
- DIAGNOSTIC_TEST
-
4 cm nasal swab - left nostril
a 4 cm nasal swab insertion in the left nostril
- DIAGNOSTIC_TEST
-
2 cm nasal swab in the left nostril
a 2 cm nasal swab insertion in the left nostril
- DIAGNOSTIC_TEST
-
4 cm nasal swab - right nostril
a 4 cm nasal swab insertion in the right nostril
- DIAGNOSTIC_TEST
-
2 cm nasal swab - right nostril
a 2 cm nasal swab insertion in the right nostril
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-01
- Primary Completion
- 2023-02-26
- Completion
- 2023-02-26
Countries
- Denmark
Study Locations
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