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Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.
We will include citizens referred for outpatient testing for COVID-19 who will be offered to participante in the study on a volunteer basis. Participants are all volunteers, who are attending the test facilities to obtain a PCR test. Participants are required to provide oral and written informed consent to participate before entering the study. The inclusion criterion is 18 years or more of age. Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients).
The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing.
The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR as usual. The diagnostic accuracy and SARS-CoV-2 viral load will be compared using independent t-test. The participants will be asked to complete a questionnaire regarding their symptoms and the number of sick days. All data will be documented on-site in a secure web database (REDCap).
The primary outcome will be reported as:
• SARS-CoV-2 RNA by RT-PCR test result (positive, negative, inconclusive)
The secondary outcome will be reported as:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oropharyngeal swab only including the posterior oropharyngeal wall | Experimental | An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only |
|
| Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils | Experimental | An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An Oropharyngeal swab | Procedure | An Oropharyngeal swab performed for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| RT-PCR results | The detection rate of SARS-CoV-2 RNA | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Sycle threshold (Ct) | SARS-CoV-2 RT-PCR cycle threshold (Ct) values | Day 1 |
| Inconclusive tests | Number of inconclusive RT-PCR tests results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Todsen, MD, PhD | Contact | +45 35466008 | tobias.todsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillerød Covid-19 Testcenter | Recruiting | Copenhagen | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38865190 | Derived | Hartvigsen B, Jakobsen KK, Benfield T, Gredal NT, Ersboll AK, Gronlund MW, Bundgaard H, Andersen MP, Steenhard N, von Buchwald C, Todsen T. Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 12;13:e47446. doi: 10.2196/47446. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 21, 2022 | Jan 10, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
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| Day 1 |
| Test discomfort | Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort) | Day 1 |
| Development of COVID-19 disease after testing | Online questionare about symptoms send by email | 1 month |
| Test accuracy between healthcare workers | SARS-CoV-2 detection rate for each healthcare worker | Day 1 |
| Participants oropharynx anatomy | Mallampati Score of participants | Day 1 |
| Valby | Recruiting | Copenhagen | 2500 | Denmark |
|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |