COVID-19 Pandemic Clinical Trial
— COVID-19Official title:
Diagnostic Accuracy of Self-collected Versus Healthcare Collected Anterior Nose Swabs for SARS-CoV-2 Detection - a Randomized Controlled Trial.
Verified date | May 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current Coronavirus Disease 2019 (COVID-19) pandemic continues to be a worldwide health emergency. To contain the spread of disease, high demands on testing availability and capacity are observed. Although polymerase chain reaction (PRC) is the golden standard method in detecting infection with COVID-19, the procedure is time consuming and requires healthcare personnel and laboratories. Rapid antigen tests, however, have several potential benefits including greater scalability and results are provided much quicker. So far, sampling for rapid antigen tests is predominantly performed by health care personnel. Though, the testing and analyzing procedure of an antigen test seems manageable by laymen but the validity of a self-performed rapid antigen test is sparsely examined. Thus, the investigators wish to conduct a study evaluating the diagnostic accuracy of self-performed rapid antigen test for detecting COVID-19 infection by comparing self-performed and healthcare-performed rapid antigen tests on the same individual while using a PCR tests as a control.
Status | Completed |
Enrollment | 3070 |
Est. completion date | May 6, 2022 |
Est. primary completion date | March 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Age = 16 years - Having a scheduled appointment for a COVID-19 test at one of the test centers run by Testcenter Danmark in the Capital Region Exclusion Criteria: - Non-fluent in Danish - Impaired citizen i.e. not capable of an independent self-testing - Neck breathers (Tracheostomy/laryngectomy patients) - Nasopharyngeal or oropharyngeal anomalies disallowing sampling using swabs |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet-Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Copenhagen Medical A/S, Emergency Medical Services, Capital Region, Denmark, Technical University of Denmark |
Denmark,
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Lindner AK, Nikolai O, Kausch F, Wintel M, Hommes F, Gertler M, Krüger LJ, Gaeddert M, Tobian F, Lainati F, Köppel L, Seybold J, Corman VM, Drosten C, Hofmann J, Sacks JA, Mockenhaupt FP, Denkinger CM. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J. 2021 Apr 15;57(4). pii: 2003961. doi: 10.1183/13993003.03961-2020. Print 2021 Apr. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of the self-collected rapid antigen test compared to healthcare collected test | This applies to both specimen from the anterior part of the nose and from the oropharynx | 48 hours from sampling to results of RT-PCR analysis | |
Secondary | Diagnostic accuracy including sensitivity and specificity of self-collected and healthcare collected rapid antigen test to RT-PCR tests collected by health care personnel | These measures apply to both specimen from the anterior part of the nose and from the oropharynx | 30 minutes from sampling to results of the two rapid antigen tests |
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