At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Diagnostic Accuracy of Self-collected Versus Healthcare Collected Anterior Nose Swabs for SARS-CoV-2 Detection - a Randomized Controlled Trial.
In Brief
A clinical study evaluating Collection of nasal and oropharyngeal specimen for COVID19 antigen test for COVID-19 Pandemic. Completed, enrolled 3,070 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Regarding two independent sampling procedures from the anterior part of the nose and the oropharynx, participants are randomized to either perform the sampling by themselves with written instructions or having the procedure performed by trained personnel. The specimen is meant for a rapid antigen test for COVID-19 infection.