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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 cm nasal swab in the right nostril, and 4 cm nasal swab in the left nostril | Experimental |
| |
| 4 cm nasal swab in the right nostril, and 2 cm nasal swab in the left nostril | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 cm nasal swab - left nostril | Diagnostic Test | a 4 cm nasal swab insertion in the left nostril |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy (sensitivity and specificity) of SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) using nasal swabs collected at 2 cm versus 4 cm insertion depth, with RT-PCR as the reference standard | Baseline (during the study visit at the time of sample collection). Ag-RDT results were available immediately, whereas RT-PCR results were reported the following days (1-3 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Test discomfort on a 10-point VAS-scale | Test discomfort was evaluated using a 10-point visual analogue scale (VAS), ranging from 0 (no discomfort) to 10 (worst imaginable discomfort). | Baseline (during the study visit at the time of sample collection). |
| Self-reported symptoms of disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
Study Protocol
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| 2 cm nasal swab in the left nostril | Diagnostic Test | a 2 cm nasal swab insertion in the left nostril |
|
| 4 cm nasal swab - right nostril | Diagnostic Test | a 4 cm nasal swab insertion in the right nostril |
|
| 2 cm nasal swab - right nostril | Diagnostic Test | a 2 cm nasal swab insertion in the right nostril |
|
Self-reported symptoms of SARS-CoV-2 infection collected via questionnaire at enrollment, including presence, type, and duration of symptoms (e.g., fever, cough, sore throat, nasal congestion, loss of taste or smell) |
| Baseline (during the study visit at the time of sample collection). Self-reported symptoms of disease were collected immediately prior to testing, during the study visit. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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