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Clinical Trial Summary

To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing. For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status. Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples. 30 companies with a total of 55 tests participate in this nationwide study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04913116
Study type Observational
Source Hvidovre University Hospital
Contact
Status Completed
Phase
Start date January 18, 2021
Completion date September 9, 2021

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